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Neuromodulation for Accidental Bowel Leakage (NOTABLe)

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ClinicalTrials.gov Identifier: NCT03278613
Recruitment Status : Completed
First Posted : September 11, 2017
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of California, San Diego
Duke University
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
NICHD Pelvic Floor Disorders Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Fecal Incontinence
Bowel Incontinence
Intervention Device: ES-130
Enrollment 166
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Percutaneous Tibial Nerve Stimulation (PTNS) Validated Sham
Hide Arm/Group Description

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Period Title: Overall Study
Started 111 55
Completed 108 54
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             3             1
Arm/Group Title PTNS Sham Total
Hide Arm/Group Description

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Total of all reporting groups
Overall Number of Baseline Participants 111 55 166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 55 participants 166 participants
63.5  (12) 63.8  (11) 63.6  (12)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 55 participants 166 participants
Female
111
 100.0%
55
 100.0%
166
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 55 participants 166 participants
Hispanic or Latino
10
   9.0%
6
  10.9%
16
   9.6%
Not Hispanic or Latino
99
  89.2%
49
  89.1%
148
  89.2%
Unknown or Not Reported
2
   1.8%
0
   0.0%
2
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 55 participants 166 participants
American Indian or Alaska Native
1
   0.9%
1
   1.8%
2
   1.2%
Asian
1
   0.9%
1
   1.8%
2
   1.2%
Native Hawaiian or Other Pacific Islander
1
   0.9%
1
   1.8%
2
   1.2%
Black or African American
10
   9.0%
9
  16.4%
19
  11.4%
White
95
  85.6%
39
  70.9%
134
  80.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.7%
4
   7.3%
7
   4.2%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 111 participants 55 participants 166 participants
29.2  (7) 29.7  (6) 29.4  (7)
Current Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 55 participants 166 participants
Yes
9
   8.1%
5
   9.1%
14
   8.4%
No
102
  91.9%
50
  90.9%
152
  91.6%
Ever Pregnant  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 55 participants 166 participants
Yes
107
  96.4%
50
  90.9%
157
  94.6%
No
4
   3.6%
5
   9.1%
9
   5.4%
Number of Vaginal Deliveries  
Median (Full Range)
Unit of measure:  Deliveries per participant
Number Analyzed 111 participants 55 participants 166 participants
2
(0 to 9)
2
(0 to 7)
2
(0 to 9)
Number of Cesarean Deliveries  
Median (Full Range)
Unit of measure:  Deliveries per participant
Number Analyzed 111 participants 55 participants 166 participants
0
(0 to 4)
0
(0 to 1)
0
(0 to 4)
Menstrual Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 55 participants 166 participants
pre-menopausal
11
   9.9%
4
   7.3%
15
   9.0%
post-menopausal
92
  82.9%
49
  89.1%
141
  84.9%
not sure
8
   7.2%
2
   3.6%
10
   6.0%
1.Primary Outcome
Title Change From Baseline St. Mark's (Vaizey) Score
Hide Description The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week [4, 8, or 12] Score minus the score at baseline.
Time Frame 4, 8, and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 108 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 4 Number Analyzed 102 participants 50 participants
-2.8
(-3.5 to -2)
-3.3
(-4.5 to -2.1)
Week 8 Number Analyzed 105 participants 52 participants
-4.3
(-5.2 to -3.3)
-4.1
(-5.4 to -2.9)
Week 12 Number Analyzed 104 participants 54 participants
-5.3
(-6.3 to -4.3)
-3.9
(-5.3 to -2.6)
2.Secondary Outcome
Title Responder to Treatment
Hide Description Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score
Time Frame 4, 8, and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 108 54
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 102 participants 50 participants
Responder
39
  38.2%
24
  48.0%
Non-responder
63
  61.8%
26
  52.0%
Week 8 Number Analyzed 105 participants 52 participants
Responder
54
  51.4%
29
  55.8%
Non-responder
51
  48.6%
23
  44.2%
Week 12 Number Analyzed 104 participants 54 participants
Responder
64
  61.5%
26
  48.1%
Non-responder
40
  38.5%
28
  51.9%
3.Secondary Outcome
Title Change From Baseline Number of Fecal Incontinence Events Per Week
Hide Description Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 53
Mean (95% Confidence Interval)
Unit of Measure: episodes per week
Week 8 Number Analyzed 103 participants 52 participants
-2.4
(-3.1 to -1.6)
-1.6
(-3.2 to 0)
Week 12 Number Analyzed 101 participants 51 participants
-2.3
(-3.2 to -1.5)
-2.1
(-3.7 to -0.4)
4.Secondary Outcome
Title Change From Baseline Number of Urge Fecal Incontinence Events Per Week
Hide Description Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 53
Mean (95% Confidence Interval)
Unit of Measure: episodes per week
Week 8 Number Analyzed 103 participants 52 participants
-1.3
(-1.8 to -0.8)
-0.4
(-1.1 to 0.2)
Week 12 Number Analyzed 101 participants 51 participants
-1.1
(-1.6 to -0.6)
-0.8
(-1.4 to -0.1)
5.Secondary Outcome
Title Change From Baseline Number of Bowel Movements Per Week
Hide Description Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 53
Mean (95% Confidence Interval)
Unit of Measure: episodes per week
Week 8 Number Analyzed 103 participants 52 participants
-1.8
(-3 to -0.6)
-0.2
(-1.6 to 1.1)
Week 12 Number Analyzed 101 participants 51 participants
-1.8
(-2.8 to -0.9)
-1.5
(-2.8 to -0.2)
6.Secondary Outcome
Title Change From Baseline Number of Urge Bowel Movements Per Week
Hide Description Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 53
Mean (95% Confidence Interval)
Unit of Measure: episodes per week
Week 8 Number Analyzed 103 participants 52 participants
-1.9
(-2.9 to -0.8)
-1.1
(-2.2 to -0.1)
Week 12 Number Analyzed 101 participants 51 participants
-2.3
(-3.2 to -1.3)
-2.2
(-3.3 to -1.1)
7.Secondary Outcome
Title Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week
Hide Description Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 53
Mean (95% Confidence Interval)
Unit of Measure: episodes per week
Week 8 Number Analyzed 103 participants 52 participants
1
(0.6 to 1.4)
0.8
(0.3 to 1.3)
Week 12 Number Analyzed 101 participants 51 participants
1.3
(0.9 to 1.7)
0.8
(0.2 to 1.4)
8.Secondary Outcome
Title 50% Improvement in Fecal Incontinence Episodes Per Week
Hide Description Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 102 50
Measure Type: Count of Participants
Unit of Measure: Participants
Week 8 Number Analyzed 99 participants 49 participants
>= 50% Improvement
38
  38.4%
14
  28.6%
< 50% Improvement
61
  61.6%
35
  71.4%
Week 12 Number Analyzed 97 participants 48 participants
>= 50% Improvement
51
  52.6%
19
  39.6%
< 50% Improvement
46
  47.4%
29
  60.4%
9.Secondary Outcome
Title 75% Improvement in Fecal Incontinence Episodes Per Week
Hide Description Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 102 50
Measure Type: Count of Participants
Unit of Measure: Participants
Week 8 Number Analyzed 99 participants 49 participants
>= 75% Improvement
19
  19.2%
10
  20.4%
< 75% Improvement
80
  80.8%
39
  79.6%
Week 12 Number Analyzed 97 participants 48 participants
>= 75% Improvement
32
  33.0%
13
  27.1%
< 75% Improvement
65
  67.0%
35
  72.9%
10.Secondary Outcome
Title Patient Global Impression-Improvement
Hide Description The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)
Time Frame 4, 8, and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 108 54
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 103 participants 50 participants
Improved
20
  19.4%
13
  26.0%
No improvement
83
  80.6%
37
  74.0%
Week 8 Number Analyzed 106 participants 50 participants
Improved
36
  34.0%
17
  34.0%
No improvement
70
  66.0%
33
  66.0%
Week 12 Number Analyzed 103 participants 54 participants
Improved
47
  45.6%
21
  38.9%
No improvement
56
  54.4%
33
  61.1%
11.Other Pre-specified Outcome
Title Change From Baseline ABLe Liquid Score
Hide Description The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
-0.3
(-0.4 to -0.1)
-0.5
(-0.8 to -0.2)
Week 12 Number Analyzed 103 participants 54 participants
-0.6
(-0.8 to -0.4)
-0.7
(-1 to -0.4)
12.Other Pre-specified Outcome
Title Change From Baseline ABLe Solid Score
Hide Description The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
-0.5
(-0.7 to -0.3)
-0.4
(-0.6 to -0.1)
Week 12 Number Analyzed 103 participants 54 participants
-0.7
(-0.9 to -0.5)
-0.7
(-1 to -0.4)
13.Other Pre-specified Outcome
Title Change From Baseline ABLe Mucus Score
Hide Description The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 105 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 104 participants 51 participants
-0.5
(-0.7 to -0.3)
-0.4
(-0.7 to -0.1)
Week 12 Number Analyzed 102 participants 54 participants
-0.7
(-0.9 to -0.5)
-0.4
(-0.7 to -0.1)
14.Other Pre-specified Outcome
Title Change From Baseline ABLe Gas Score
Hide Description The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
-0.3
(-0.5 to -0.1)
-0.2
(-0.5 to 0.1)
Week 12 Number Analyzed 103 participants 54 participants
-0.4
(-0.6 to -0.3)
-0.4
(-0.7 to -0.1)
15.Other Pre-specified Outcome
Title Change From Baseline ABLe Predictability/Awareness Score
Hide Description The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
0
(-0.2 to 0.1)
0
(-0.2 to 0.2)
Week 12 Number Analyzed 103 participants 54 participants
-0.2
(-0.4 to -0.1)
0
(-0.2 to 0.2)
16.Other Pre-specified Outcome
Title Change From Baseline ABLe Control Score
Hide Description The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
-0.3
(-0.5 to -0.2)
-0.3
(-0.6 to -0.1)
Week 12 Number Analyzed 103 participants 54 participants
-0.6
(-0.8 to -0.4)
-0.6
(-0.9 to -0.3)
17.Other Pre-specified Outcome
Title Change From Baseline ABLe Ancillary Bowel Symptoms Score
Hide Description The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
-0.4
(-0.5 to -0.2)
-0.3
(-0.6 to -0.1)
Week 12 Number Analyzed 103 participants 54 participants
-0.7
(-0.9 to -0.5)
-0.4
(-0.6 to -0.1)
18.Other Pre-specified Outcome
Title Change From Baseline ABLe Overall Score
Hide Description The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
-0.4
(-0.5 to -0.2)
-0.3
(-0.6 to -0.1)
Week 12 Number Analyzed 103 participants 54 participants
-0.7
(-0.9 to -0.5)
-0.4
(-0.6 to -0.1)
19.Other Pre-specified Outcome
Title Patient Global Symptom Control
Hide Description The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)
Time Frame Baseline and 4, 8, and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 111 55
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 111 participants 54 participants
No Control
18
  16.2%
10
  18.5%
Control
93
  83.8%
44
  81.5%
Week 4 Number Analyzed 105 participants 50 participants
No Control
46
  43.8%
25
  50.0%
Control
59
  56.2%
25
  50.0%
Week 8 Number Analyzed 106 participants 52 participants
No Control
70
  66.0%
33
  63.5%
Control
36
  34.0%
19
  36.5%
Week 12 Number Analyzed 104 participants 54 participants
No Control
82
  78.8%
40
  74.1%
Control
22
  21.2%
14
  25.9%
20.Other Pre-specified Outcome
Title Change From Baseline FIQL Lifestyle Score
Hide Description The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 105 participants 51 participants
0.3
(0.2 to 0.5)
0.4
(0.2 to 0.6)
Week 12 Number Analyzed 102 participants 54 participants
0.6
(0.5 to 0.8)
0.4
(0.2 to 0.6)
21.Other Pre-specified Outcome
Title Change From Baseline FIQL Coping Score
Hide Description The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
0.4
(0.3 to 0.5)
0.4
(0.2 to 0.6)
Week 12 Number Analyzed 102 participants 54 participants
0.6
(0.5 to 0.8)
0.5
(0.3 to 0.7)
22.Other Pre-specified Outcome
Title Change From Baseline FIQL Depression Score
Hide Description The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 106 participants 51 participants
0.3
(0.2 to 0.4)
0.2
(0 to 0.4)
Week 12 Number Analyzed 102 participants 54 participants
0.5
(0.4 to 0.6)
0.2
(0.1 to 0.4)
23.Other Pre-specified Outcome
Title Change From Baseline FIQL Embarrassment Score
Hide Description The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 105 participants 51 participants
0.4
(0.3 to 0.5)
0.4
(0.2 to 0.6)
Week 12 Number Analyzed 102 participants 53 participants
0.7
(0.6 to 0.9)
0.4
(0.3 to 0.6)
24.Other Pre-specified Outcome
Title Change From Baseline FISI Patient Score
Hide Description The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 102 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 100 participants 50 participants
-4.9
(-7.1 to -2.8)
-5.9
(-8.7 to -3.1)
Week 12 Number Analyzed 95 participants 52 participants
-7.5
(-9.7 to -5.3)
-6.7
(-10.1 to -3.3)
25.Other Pre-specified Outcome
Title Change From Baseline FISI Doctor Score
Hide Description The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 102 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 100 participants 50 participants
-5
(-7.3 to -2.8)
-6.3
(-9.2 to -3.4)
Week 12 Number Analyzed 95 participants 52 participants
-7.4
(-9.8 to -5)
-7
(-10.5 to -3.5)
26.Other Pre-specified Outcome
Title Change From Baseline MMHQ Incontinence Impact Score
Hide Description The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 104 participants 51 participants
-9.4
(-14.5 to -4.2)
-11.3
(-17.9 to -4.6)
Week 12 Number Analyzed 103 participants 52 participants
-17.2
(-23 to -11.5)
-15.9
(-23.4 to -8.3)
27.Other Pre-specified Outcome
Title Change From Baseline MMHQ Role Limitations Score
Hide Description The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 104 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 103 participants 49 participants
-9.8
(-14.6 to -5.1)
-3.1
(-10.4 to 4.3)
Week 12 Number Analyzed 101 participants 52 participants
-17.5
(-22.6 to -12.3)
-9.9
(-17.1 to -2.6)
28.Other Pre-specified Outcome
Title Change From Baseline MMHQ Physical Limitations Score
Hide Description The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 104 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 102 participants 49 participants
-10.3
(-15.3 to -5.3)
-3.8
(-9.2 to 1.6)
Week 12 Number Analyzed 100 participants 52 participants
-20.4
(-25.5 to -15.2)
-10.6
(-16.6 to -4.5)
29.Other Pre-specified Outcome
Title Change From Baseline MMHQ Social Limitations Score
Hide Description The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 102 participants 50 participants
-9.6
(-15.3 to -3.9)
-1.8
(-7.5 to 3.9)
Week 12 Number Analyzed 102 participants 53 participants
-14.8
(-20.1 to -9.5)
-8.6
(-14.6 to -2.7)
30.Other Pre-specified Outcome
Title Change From Baseline MMHQ Personal Relationship Score
Hide Description The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 75 35
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 70 participants 28 participants
-5
(-11.6 to 1.6)
-2.2
(-11.5 to 7)
Week 12 Number Analyzed 71 participants 35 participants
-6.2
(-11.3 to -1)
-11.4
(-23.2 to 0.4)
31.Other Pre-specified Outcome
Title Change From Baseline MMHQ Emotional Function Score
Hide Description The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 104 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 103 participants 51 participants
-7.2
(-11.7 to -2.7)
-4.6
(-10.6 to 1.5)
Week 12 Number Analyzed 101 participants 52 participants
-14.4
(-19.1 to -9.6)
-7.4
(-14.3 to -0.4)
32.Other Pre-specified Outcome
Title Change From Baseline MMHQ Sleep/Energy Score
Hide Description The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 104 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 101 participants 50 participants
-7.2
(-11.4 to -3)
-4.3
(-10.8 to 2.3)
Week 12 Number Analyzed 98 participants 51 participants
-11
(-15.2 to -6.8)
-6.4
(-12.4 to -0.3)
33.Other Pre-specified Outcome
Title Change From Baseline MMHQ Severity Measures Score
Hide Description The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week [8 or 12] Score minus the score at baseline.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 105 51
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 104 participants 47 participants
-9.1
(-13.2 to -5)
-10.7
(-15.9 to -5.6)
Week 12 Number Analyzed 101 participants 50 participants
-17
(-21.3 to -12.6)
-11.8
(-17 to -6.6)
34.Other Pre-specified Outcome
Title Change From Baseline CRAIQ Score
Hide Description The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 105 participants 51 participants
-12.9
(-17.1 to -8.7)
-12.8
(-19.6 to -5.9)
Week 12 Number Analyzed 103 participants 54 participants
-19.1
(-24.2 to -14)
-14.5
(-22.2 to -6.9)
35.Other Pre-specified Outcome
Title Change From Baseline POPIQ Score
Hide Description The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 105 participants 51 participants
-3.3
(-7.2 to 0.7)
-5.1
(-8.8 to -1.5)
Week 12 Number Analyzed 103 participants 54 participants
-5.2
(-8.1 to -2.3)
-5.6
(-9.8 to -1.4)
36.Other Pre-specified Outcome
Title Change From Baseline UIQ Score
Hide Description The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 105 participants 51 participants
-3.3
(-6.4 to -0.1)
-10.2
(-15.3 to -5)
Week 12 Number Analyzed 103 participants 54 participants
-7.2
(-10.6 to -3.8)
-10.5
(-16.5 to -4.6)
37.Other Pre-specified Outcome
Title Change From Baseline PFIQ Score
Hide Description The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [8, 12] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame 8 and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 106 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 8 Number Analyzed 105 participants 51 participants
-19.4
(-27.7 to -11.1)
-28.1
(-39.9 to -16.2)
Week 12 Number Analyzed 103 participants 54 participants
-31.5
(-40.3 to -22.7)
-30.7
(-43.7 to -17.6)
38.Other Pre-specified Outcome
Title Change From Baseline PAC-SYM Abdominal Score
Hide Description The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 103 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.4
(-0.6 to -0.3)
-0.2
(-0.4 to 0)
39.Other Pre-specified Outcome
Title Change From Baseline PAC-SYM Rectal Score
Hide Description The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 103 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.1
(-0.3 to 0.0)
-0.1
(-0.3 to 0.1)
40.Other Pre-specified Outcome
Title Change From Baseline PAC-SYM Stool Score
Hide Description The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 103 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.3
(-0.5 to -0.1)
-0.2
(-0.5 to 0.0)
41.Other Pre-specified Outcome
Title Change From Baseline PAC-SYM Total Score
Hide Description The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 103 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.3
(-0.4 to -0.2)
-0.2
(-0.4 to 0.0)
42.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR NSA-PR Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 43 29
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.1
(-0.3 to 0.4)
-0.1
(-0.4 to 0.1)
43.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR NSA-CS Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 40 29
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.2
(-0.1 to 0.5)
0.2
(-0.2 to 0.6)
44.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR NSA-GQA Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 41 28
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.4
(0.1 to 0.6)
0.3
(0 to 0.5)
45.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR NSA-CI Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected for participants that were not sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 40 28
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.4
(0.1 to 0.7)
0.3
(0.0 to 0.6)
46.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR SA-AO Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only calculated for participants that were sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 46 21
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.2
(0.1 to 0.4)
0.2
(0.0 to 0.4)
47.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR SA-PR Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only collected from participants that were sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 44 19
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.1
(0.0 to 0.3)
0.0
(-0.2 to 0.2)
48.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR SA-CS Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 45 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.3
(0.1 to 0.6)
0.5
(0.2 to 0.8)
49.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR SA-GQR Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 46 21
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.3
(0.1 to 0.6)
0.4
(-0.1 to 0.9)
50.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR SA-CI Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 46 21
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.4
(0.2 to 0.6)
0.3
(0.0 to 0.6)
51.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR SA-D Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 45 21
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.0
(-0.1 to 0.2)
0.2
(-0.2 to 0.6)
52.Other Pre-specified Outcome
Title Change From Baseline PISQ-IR SA-AVG Score
Hide Description The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were sexually active.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 44 19
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.2
(0.1 to 0.4)
0.3
(0.1 to 0.5)
53.Other Pre-specified Outcome
Title Change From Baseline FIAI Hygiene Index Score
Hide Description The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 101 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-10.2
(-14 to -6.5)
-2.8
(-8.4 to 2.9)
54.Other Pre-specified Outcome
Title Change From Baseline FIAI Avoidance Index Score
Hide Description The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 101 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-12.8
(-16.1 to -9.4)
-6.4
(-12.2 to -0.6)
55.Other Pre-specified Outcome
Title Change From Baseline SF-12 Aggregate Physical Score
Hide Description The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 89 50
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.6
(1.1 to 4.2)
2.1
(-1 to 5.3)
56.Other Pre-specified Outcome
Title Change From Baseline SF-12 Aggregate Mental Score
Hide Description The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.
Arm/Group Title PTNS Sham
Hide Arm/Group Description:

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Overall Number of Participants Analyzed 89 50
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.9
(-1.3 to 3.1)
-0.7
(-4.2 to 2.9)
Time Frame 12 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PTNS Sham
Hide Arm/Group Description

PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.

ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.

All-Cause Mortality
PTNS Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   1/111 (0.90%)      0/55 (0.00%)    
Hide Serious Adverse Events
PTNS Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/111 (3.60%)      2/55 (3.64%)    
Cardiac disorders     
Myocardial infarction * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Gastrointestinal disorders     
Colitis * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Hiatus hernia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
General disorders     
Death * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Infections and infestations     
Localised infection * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Injury, poisoning and procedural complications     
Femur fracture * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumothorax * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
1
Term from vocabulary, MedDRA 17.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.00%
PTNS Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/111 (64.86%)      30/55 (54.55%)    
Cardiac disorders     
Atrial fibrillation * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Tachycardia * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Eye disorders     
Chalazion * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Photopsia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Abdominal pain * 1  2/111 (1.80%)  2 0/55 (0.00%)  0
Abdominal pain upper * 1  1/111 (0.90%)  1 2/55 (3.64%)  2
Anal paraesthesia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Chapped lips * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Constipation * 1  4/111 (3.60%)  6 2/55 (3.64%)  2
Diarrhoea * 1  6/111 (5.41%)  9 1/55 (1.82%)  1
Flatulence * 1  1/111 (0.90%)  2 0/55 (0.00%)  0
Gastritis * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Haematochezia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Hiatus hernia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Nausea * 1  2/111 (1.80%)  2 0/55 (0.00%)  0
Rectal haemorrhage * 1  2/111 (1.80%)  2 0/55 (0.00%)  0
Vomiting * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
General disorders     
Adverse drug reaction * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Application site pain * 1  2/111 (1.80%)  2 0/55 (0.00%)  0
Application site paraesthesia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Asthenia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Chest pain * 1  1/111 (0.90%)  1 1/55 (1.82%)  1
Chills * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Influenza like illness * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Injection site pain * 1  2/111 (1.80%)  2 0/55 (0.00%)  0
Malaise * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Medical device site haemorrhage * 1  9/111 (8.11%)  14 0/55 (0.00%)  0
Medical device site pain * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Puncture site pain * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Hepatobiliary disorders     
Hepatic steatosis * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Immune system disorders     
Drug hypersensitivity * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Multiple allergies * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Infections and infestations     
Bronchitis * 1  4/111 (3.60%)  4 1/55 (1.82%)  1
Eye infection * 1  2/111 (1.80%)  2 0/55 (0.00%)  0
Fungal infection * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Gastrointestinal viral infection * 1  1/111 (0.90%)  1 1/55 (1.82%)  1
Herpes zoster * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Hordeolum * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Influenza * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Nasopharyngitis * 1  7/111 (6.31%)  8 2/55 (3.64%)  2
Oral candidiasis * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Pharyngitis * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Pneumonia * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Sinusitis * 1  3/111 (2.70%)  3 1/55 (1.82%)  1
Streptococcal infection * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Tooth infection * 1  1/111 (0.90%)  1 1/55 (1.82%)  1
Upper respiratory tract infection * 1  1/111 (0.90%)  1 2/55 (3.64%)  2
Urinary tract infection * 1  14/111 (12.61%)  14 4/55 (7.27%)  4
Injury, poisoning and procedural complications     
Contusion * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Fall * 1  6/111 (5.41%)  7 1/55 (1.82%)  1
Joint injury * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Ligament sprain * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Limb injury * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Post procedural haemorrhage * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Procedural haemorrhage * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Procedural pain * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Investigations     
Blood potassium decreased * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Blood pressure increased * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Colonoscopy * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Endoscopy gastrointestinal * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Oesophagogastroduodenoscopy * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Metabolism and nutrition disorders     
Gluten sensitivity * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Gout * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/111 (2.70%)  5 2/55 (3.64%)  2
Back pain * 1  3/111 (2.70%)  3 1/55 (1.82%)  1
Diastasis recti abdominis * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Joint swelling * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Limb discomfort * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Muscle spasms * 1  3/111 (2.70%)  3 0/55 (0.00%)  0
Muscle tightness * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Muscle twitching * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal pain * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Myalgia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Neck pain * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Osteoarthritis * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Pain in extremity * 1  5/111 (4.50%)  7 0/55 (0.00%)  0
Nervous system disorders     
Amnesia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Cervical radiculopathy * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Dizziness * 1  2/111 (1.80%)  2 0/55 (0.00%)  0
Headache * 1  4/111 (3.60%)  4 1/55 (1.82%)  1
Hypoaesthesia * 1  0/111 (0.00%)  0 2/55 (3.64%)  2
Migraine * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Nerve compression * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Paraesthesia * 1  11/111 (9.91%)  16 2/55 (3.64%)  2
Sciatica * 1  2/111 (1.80%)  2 1/55 (1.82%)  1
Somnolence * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Tremor * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Renal and urinary disorders     
Dysuria * 1  1/111 (0.90%)  1 1/55 (1.82%)  1
Pollakiuria * 1  0/111 (0.00%)  0 2/55 (3.64%)  2
Urge incontinence * 1  0/111 (0.00%)  0 2/55 (3.64%)  2
Urinary incontinence * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Urinary retention * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Reproductive system and breast disorders     
Fibrocystic breast disease * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Pelvic pain * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Uterine haemorrhage * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Vaginal discharge * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Vulvovaginal pain * 1  1/111 (0.90%)  2 0/55 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/111 (1.80%)  2 1/55 (1.82%)  1
Dry throat * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Dyspnoea * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Nasal congestion * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Pulmonary hypertension * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Sinus disorder * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Throat irritation * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Upper-airway cough syndrome * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Blister * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Eczema * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Ingrowing nail * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Rash * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Rash generalised * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Skin discolouration * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Skin reaction * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Surgical and medical procedures     
Abdominal hernia repair * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Abdominoplasty * 1  0/111 (0.00%)  0 1/55 (1.82%)  1
Medical device removal * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Vascular disorders     
Hot flush * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
Hypertension * 1  1/111 (0.90%)  1 0/55 (0.00%)  0
1
Term from vocabulary, MedDRA 17.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marie Gantz
Organization: RTI International
Phone: 919-597-5110
EMail: mgantz@rti.org
Layout table for additonal information
Responsible Party: NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT03278613    
Other Study ID Numbers: 12865-29
2U24HD069031-06 ( U.S. NIH Grant/Contract )
2UG1HD069013-06 ( U.S. NIH Grant/Contract )
5UG1HD041267-18 ( U.S. NIH Grant/Contract )
5UG1HD069010-07 ( U.S. NIH Grant/Contract )
5UG1HD069006-07 ( U.S. NIH Grant/Contract )
5UG1HD041261-17 ( U.S. NIH Grant/Contract )
5UG1HD054214-12 ( U.S. NIH Grant/Contract )
5UG1HD054241-12 ( U.S. NIH Grant/Contract )
First Submitted: September 6, 2017
First Posted: September 11, 2017
Results First Submitted: March 24, 2021
Results First Posted: May 14, 2021
Last Update Posted: May 14, 2021