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Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397785
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : March 12, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Pelvic Pain
Interventions Device: ApexM
Device: Sham Device
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week. Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Period Title: Overall Study
Started 24 34
Completed 22 25
Not Completed 2 9
Arm/Group Title ApexM Device Sham Device Total
Hide Arm/Group Description InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week. Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week. Total of all reporting groups
Overall Number of Baseline Participants 24 34 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 34 participants 58 participants
32.3  (9.5) 33.8  (10.5) 33.2  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
Female
24
 100.0%
34
 100.0%
58
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.2%
0
   0.0%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.5%
4
  11.8%
7
  12.1%
White
20
  83.3%
30
  88.2%
50
  86.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants 34 participants 58 participants
24
 100.0%
34
 100.0%
58
 100.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 24 participants 34 participants 58 participants
27.0  (5.8) 28.1  (6.3) 27.6  (6.0)
Employment Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
Employed
19
  79.2%
27
  79.4%
46
  79.3%
Unemployed
5
  20.8%
7
  20.6%
12
  20.7%
Annual Household Income  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
<$25,000
8
  33.3%
5
  14.7%
13
  22.4%
$25,001-$50,000
4
  16.7%
8
  23.5%
12
  20.7%
$50,001-$75,000
8
  33.3%
7
  20.6%
15
  25.9%
$75,001-$100,000
1
   4.2%
5
  14.7%
6
  10.3%
>$100,000
3
  12.5%
9
  26.5%
12
  20.7%
Highest Education Level Completed  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
< High School
1
   4.2%
0
   0.0%
1
   1.7%
High School / GED
6
  25.0%
9
  26.5%
15
  25.9%
College
11
  45.8%
18
  52.9%
29
  50.0%
Graduate/Professional Degree
6
  25.0%
7
  20.6%
13
  22.4%
Total Parity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
0
17
  70.8%
18
  52.9%
35
  60.3%
1
2
   8.3%
6
  17.6%
8
  13.8%
>=2
5
  20.8%
10
  29.4%
15
  25.9%
Vaginal Parity  
Mean (Standard Deviation)
Unit of measure:  Vaginal Births
Number Analyzed 24 participants 34 participants 58 participants
1.8  (1.2) 1.1  (1.3) 1.3  (1.2)
Menopausal Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
Pre-Menopausal
21
  87.5%
30
  88.2%
51
  87.9%
Post-Menopausal
3
  12.5%
4
  11.8%
7
  12.1%
Pain Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 34 participants 58 participants
4.9  (3.4) 11.0  (12.6) 8.5  (10.3)
Endometriosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
Yes
8
  33.3%
18
  52.9%
26
  44.8%
No
16
  66.7%
16
  47.1%
32
  55.2%
History of Pelvic Floor Physical Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
Yes
4
  16.7%
9
  26.5%
13
  22.4%
No
20
  83.3%
25
  73.5%
45
  77.6%
History of Depression  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
Yes
9
  37.5%
21
  61.8%
30
  51.7%
No
15
  62.5%
13
  38.2%
28
  48.3%
History of Sexual Abuse  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 34 participants 58 participants
Yes
5
  20.8%
9
  26.5%
14
  24.1%
No
19
  79.2%
25
  73.5%
44
  75.9%
1.Primary Outcome
Title Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 12
Hide Description The Visual Analog Scale assesses self-reported pain scores. Patients were asked to record their average pain over the past 4 weeks by placing an "X" on a 10-cm line, with 0 representing no pain and 100 representing the worst pain imaginable. Pain scores were determined by research personnel by measuring the distance (in mm) from 0 to the X. Change = (Week 12 Score - Baseline Score).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 VAS scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.5  (30.9) -7.4  (25.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments It was calculated that 52 participants (26 in each arm) was sufficient to detect a 30% reduction in the VAS score (⍺ = 0.05, β = 0.80) from baseline to 12 weeks using paired t-tests, assuming average pain of 80-90 on the VAS and 10% drop-out. Because stratified randomization was performed on the basis of levator ani muscle spasm, there was an imbalance between the size of the sham and active groups, and 58 subjects were ultimately recruited with approval from the Institutional Review Board.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8979
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Quality of Life on Short Form 36 (SF-36) Physical Functioning Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (4.1) 1.6  (13.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9338
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Physical Health Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.13  (50.9) 21  (43.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1568
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Emotional Problems Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.6  (43.5) 2.7  (35.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3817
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Quality of Life on Short Form 36 (SF-36) Energy/Fatigue Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (19.1) 7.2  (15.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2860
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Quality of Life on Short Form 36 (SF-36) Emotional Wellbeing Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.9  (12.3) 0.8  (11.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2884
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Quality of Life on Short Form 36 (SF-36) Social Function Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.4  (15.5) 5.5  (18.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0855
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Pain on Short Form 36 (SF-36) Pain Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.2  (21.9) 18.1  (17.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0287
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Quality of Life on Short Form 36 (SF-36) General Health Scale
Hide Description Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.1  (9.9) 0  (10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2887
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Severity Scale
Hide Description The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (2.3) -0.4  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9954
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Interference Scale
Hide Description The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.06  (3.2) -1.1  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0574
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Quality of Life on Female Sexual Function Index (FSFI) Scale
Hide Description The Female Sexual Function Index is a validated, self-reported instrument used to evaluate sexual function and symptoms. The FSFI consists of 6 sub-scales: 1) desire [score range = 1.2 - 6], 2) arousal [score range = 0 - 6], 3) lubrication [score range = 0 - 6], 4) orgasm [score range = 0 - 6], 5) satisfaction [score range = 0 - 6], 6) pain [score range = 0 - 6]. The full FSFI consists of 19 questions, and the total score ranges from 1.2 - 36. Change = (Week 12 Score - Baseline Score). Higher scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 FSFI scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (8.0) 1.9  (9.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7827
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Pelvic Organ Prolapse Distress Inventory (POPDI) Sub-Scale
Hide Description The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.7  (11.7) -9.3  (13.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2114
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Colorectal Anal Distress Inventory (CRADI) Sub-Scale
Hide Description The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.1  (8.6) -6.5  (14.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4986
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) Sub-Scale
Hide Description The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.3  (17.6) -10  (16.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4610
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Total Scale
Hide Description The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 22 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.2  (28.8) -25.8  (33.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2556
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Weekly Ibuprofen Use
Hide Description Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: mg/week
200  (836) -400  (1201)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0723
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Weekly Naprosyn Use
Hide Description Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: mg/week
-35.3  (250) -62.9  (288)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7456
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Weekly Acetaminophen Use
Hide Description Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: mg/week
125  (559) -333  (1238)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1380
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Weekly Opioid Use
Hide Description Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description:
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: morphine equivalents/week
-0.25  (1.1) 0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ApexM Device, Sham Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3155
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse Event Reporting Description Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
 
Arm/Group Title ApexM Device Sham Device
Hide Arm/Group Description InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week. Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
All-Cause Mortality
ApexM Device Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/34 (0.00%)    
Hide Serious Adverse Events
ApexM Device Sham Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/34 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ApexM Device Sham Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/24 (58.33%)      4/34 (11.76%)    
Product Issues     
Tingling Sensation  [1]  8/24 (33.33%)  8 0/34 (0.00%)  0
Renal and urinary disorders     
Urinary Frequency   2/24 (8.33%)  2 0/34 (0.00%)  0
Reproductive system and breast disorders     
Vaginal Discharge   2/24 (8.33%)  2 2/34 (5.88%)  2
Pelvic Cramping   2/24 (8.33%)  2 1/34 (2.94%)  1
Vaginal Soreness   0/24 (0.00%)  0 1/34 (2.94%)  1
Indicates events were collected by systematic assessment
[1]
Resolved with device repositioning and further instruction/teaching about correct positioning
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: Erica Magelky, Principal Investigator
Organization: Cleveland Clinic Foundation
Phone: 713-628-5357
EMail: magelke@ccf.org
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02397785    
Other Study ID Numbers: 15-150
First Submitted: March 20, 2015
First Posted: March 25, 2015
Results First Submitted: December 26, 2017
Results First Posted: March 12, 2018
Last Update Posted: July 26, 2019