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Trial record 1 of 1 for:    An Investigation of TReatment of FecAl IncontiNence using the TOPAS Sling
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Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence (TRANSFORM)

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ClinicalTrials.gov Identifier: NCT01090739
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
ASTORA Women's Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fecal Incontinence
Intervention Device: TOPAS Treatment for Fecal Incontinence
Enrollment 207
Recruitment Details Subject recruitment occurred from July 2010 - December 2012.
Pre-assignment Details Following enrollment (i.e., signing informed consent form), subjects underwent two screening visits to evaluate and confirm eligibility for the TOPAS implant procedures.
Arm/Group Title TOPAS
Hide Arm/Group Description TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Period Title: Enrollment
Started 207 [1]
Completed 152
Not Completed 55
Reason Not Completed
Withdrawal by Subject             24
Protocol Violation             14
Lost to Follow-up             5
Physician Decision             5
Sponsor termination of site             4
Study implant limit reached             2
Adverse Event             1
[1]
Subject enrollment = signed informed consent form
Period Title: 12 Month Follow-up
Started 152
Completed 147
Not Completed 5
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             1
Physician Decision             1
Death             1
Period Title: 24 Month Follow-up
Started 147
Completed 138
Not Completed 9
Reason Not Completed
Withdrawal by Subject             7
Lost to Follow-up             1
Death             1
Period Title: 36 Month Follow-up
Started 138
Completed 115
Not Completed 23
Reason Not Completed
Withdrawal by Subject             6
Visit still pending             17
Arm/Group Title TOPAS
Hide Arm/Group Description TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Baseline Participants 152
Hide Baseline Analysis Population Description
All subjects who met the study inclusion/exclusion criteria and were implanted with the TOPAS device.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants
59.6  (9.7)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Women Number Analyzed 152 participants
152
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
White/Caucasian 137
Black or African American 10
Asian 1
Hispanic/Latina 3
Other 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 152 participants
152
Obstetric History - Gravidity   [1] 
Mean (Standard Deviation)
Unit of measure:  Number
Number Analyzed 152 participants
3.0  (1.8)
[1]
Measure Description: Number of times subjects have been pregnant
Obstetric History - Parity   [1] 
Mean (Standard Deviation)
Unit of measure:  Number
Number Analyzed 152 participants
2.6  (1.4)
[1]
Measure Description: Parity is defined as the number of pregnancies carried to gestation
Obstetric History - # of Vaginal Deliveries   [1] 
Mean (Standard Deviation)
Unit of measure:  Number
Number Analyzed 152 participants
2.4  (1.5)
[1]
Measure Description: The number of times a women delivered vaginally
Obstetric History - # of Caesarean deliveries   [1] 
Mean (Standard Deviation)
Unit of measure:  Number
Number Analyzed 152 participants
0.1  (0.5)
[1]
Measure Description: women delivering via a caesarean procedure
Menopausal Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Pre-menopausal 20
Peri-menopausal 6
Post-menopausal 126
Concomitant Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
# Smoked within past 6 months 8
# Caffeine use on a regular basis 102
# Rgular laxative use within past 5 years 18
Duration of Fecal Incontinence  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 152 participants
110.0  (113.5)
Etiology of Fecal Incontinence   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Anorectal trauma 6
Obstetric trauma 87
Idiopathic/unknown 62
Other 4
[1]
Measure Description: Subjects can have multiple etiologies so total does not equal 152 (number of subjects)
Rectal soft tissue scarring  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Present 26
Absent 126
Baseline Medical History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Previous hysterectomy / oophorectomy 74
Previous prolapse / UI repair 70
Gastrointestional reflux disease 65
Hypertension 60
Depressive disorder 56
Systemic pain 55
Hyperlipidemia 53
Pelvic area pain 52
Diverticulitis 41
Urinary incontinence 39
Hypothroid 38
Previous cholecystectomy 38
Hemorrhoids 36
Irritable bowel syndrome 31
Previous anal sphincter repair 31
Headaches 29
Vaginal atrophy 23
Diabetes 19
Vaginal prolapse 8
Rectal prolapse 6
Gallstones 2
[1]
Measure Description: Subjects can have multiple medical history items so the total does not equal 152 (number of subjects).
Baseline Fecal Incontinence Medication   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Opioid-receptor agents 30
Bulking agents 22
Osmotic laxatives 8
Anti-cholinergic agents 6
Other meds 5
Bile acid sequestrants 3
[1]
Measure Description: Subjects taking medications does not equal 152 (number of subjects).
Failed Fecal Incontinence Conservative Therapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Diet modification and medication 22
Diet modification and pelvic floor muscle training 49
Medication and pelvic floor muscle training 20
Diet, medication and pelvic floor training 61
[1]
Measure Description: Subjects had to fail at least two conservative therapies for their FI prior to entry into the study.
Hemorrhoids  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Present 34
Absent 118
Anal Resting Tone  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Present 141
Absent 11
Anorectal Manometry - Pressures  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 152 participants
Mean Maximum Resting Pressure 31.5  (21.9)
Mean Maximum Squeeze Pressure 60.1  (42.6)
Anorectal Manometry - Volumes  
Mean (Standard Deviation)
Unit of measure:  Cc
Number Analyzed 152 participants
First sensation volume 43.1  (30.9)
Maximum tolerated volume 124.8  (61.9)
External Anal Sphincter Defects  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Present 79
Absent 73
Internal Anal Sphincter Defects  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants
Present 42
Absent 110
External Anal Sphincter Defect Extent  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 152 participants
95.3  (45.0)
Internal Anal Sphincter Defect Extent  
Mean (Standard Deviation)
Unit of measure:  Degrees
Number Analyzed 152 participants
110.0  (53.7)
1.Primary Outcome
Title Percentage of Responders
Hide Description The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of treatment responders
69.1
(61.1 to 76.3)
2.Secondary Outcome
Title Change in Fecal Incontinence Episodes
Hide Description Number of fecal incontinence episodes in a 14 day period
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Median (Full Range)
Unit of Measure: fecal incontinent episodes/14 days
Baseline
18
(4 to 81)
3 Months
5
(0 to 94)
6 Months
5
(0 to 67)
12 Months
5
(0 to 80)
24 Months
5
(0 to 73)
36 Months
5
(0 to 52)
3.Secondary Outcome
Title Change in Fecal Incontinence Days
Hide Description Number of fecal incontinence days in a 14 day period
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Median (Full Range)
Unit of Measure: fecal incontinent days/14 days
Baseline
10
(3 to 14)
3 Months
4
(0 to 14)
6 Months
4
(0 to 14)
12 Months
4
(0 to 14)
24 Months
4
(0 to 14)
36 Months
4
(0 to 14)
4.Secondary Outcome
Title Change in Urge Fecal Incontinence Episodes
Hide Description Number of urge fecal incontinence episodes in a 14 day period
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Median (Full Range)
Unit of Measure: urge fecal incontinent episodes/14 days
Baseline
4
(0 to 52)
3 Months
0
(0 to 16)
6 Months
0
(0 to 18)
12 Months
0
(0 to 29)
24 Months
0
(0 to 39)
36 Months
0
(0 to 34)
5.Secondary Outcome
Title Change in Wexner Symptom Severity Score
Hide Description Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 13.9  (2.7)
3 Months 9.4  (4.3)
6 Months 9.8  (4.4)
12 Months 9.6  (3.9)
24 Months 9.5  (4.2)
36 Months 9.4  (4.3)
6.Secondary Outcome
Title Change in Fecal Incontinence Quality of Life Score
Hide Description Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
Lifestyle - Baseline 2.6  (0.8)
Lifestyle - 3 Months 3.3  (0.7)
Lifestyle - 6 Months 3.3  (0.7)
Lifestyle - 12 Months 3.4  (0.7)
Lifestyle - 24 Months 3.4  (0.7)
Lifestyle - 36 Months 3.4  (0.7)
Coping - Baseline 1.7  (0.6)
Coping - 3 Months 2.6  (0.8)
Coping - 6 Months 2.6  (0.9)
Coping - 12 Months 2.7  (0.9)
Coping - 24 Months 2.7  (0.9)
Coping - 36 Months 2.7  (0.9)
Depression - Baseline 2.4  (0.6)
Depression - 3 Months 3.0  (0.7)
Depression - 6 Months 3.1  (0.7)
Depression - 12 Months 3.1  (0.7)
Depression - 24 Months 3.1  (0.7)
Depression - 36 Months 3.2  (0.7)
Embarrassment - Baseline 1.6  (0.6)
Embarrassment - 3 Months 2.5  (0.9)
Embarrassment - 6 Months 2.6  (1.0)
Embarrassment - 12 Months 2.7  (0.9)
Embarrassment - 24 Months 2.7  (0.9)
Embarrassment - 36 Months 2.7  (0.9)
7.Secondary Outcome
Title Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Hide Description

Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).

The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale.

Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total PFDI Score - Baseline 104.1  (47.4)
Total PFDI Score - 3 Months 69.7  (43.1)
Total PFDI Score - 6 Months 68.8  (45.9)
Total PFDI Score - 12 Months 66.7  (43.4)
Total PFDI Score - 24 Months 65.7  (43.9)
Total PFDI Score - 36 Months 70.3  (51.2)
Colorectal-Anal Subscale - Baseline 54.8  (16.2)
Colorectal-Anal Subscale - 3 Months 33.3  (17.7)
Colorectal-Anal Subscale - 6 Months 33.0  (19.8)
Colorectal-Anal Subscale - 12 Months 32.1  (19.2)
Colorectal-Anal Subscale - 24 Months 31.5  (19.7)
Colorectal-Anal Subscale - 36 Months 33.5  (21.0)
Urinary Subscale - Baseline 27.2  (25.1)
Urinary Subscale - 3 Months 21.4  (21.5)
Urinary Subscale - 6 Months 21.4  (22.7)
Urinary Subscale - 12 Months 21.5  (21.9)
Urinary Subscale - 24 Months 22.2  (22.1)
Urinary Subscale - 36 Months 22.6  (23.0)
POP Subscale - Baseline 21.9  (19.5)
POP Subscale - 3 Months 14.9  (15.6)
POP Subscale - 6 Months 14.2  (14.9)
POP Subscale - 12 Months 12.8  (13.9)
POP Subscale - 24 Months 12.1  (13.8)
POP Subscale - 36 Months 13.8  (16.9)
8.Secondary Outcome
Title Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Hide Description

Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).

The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score.

Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total PDFI Score - Baseline 79.6  (52.3)
Total PDFI Score - 3 Months 41.0  (43.5)
Total PDFI Score - 6 Months 39.6  (48.4)
Total PDFI Score - 12 Months 37.9  (43.5)
Total PDFI Score - 24 Months 35.2  (45.5)
Total PDFI Score - 36 Months 38.5  (48.5)
Colorectal-Anal Subscale - Baseline 51.7  (25.5)
Colorectal-Anal Subscale - 3 Months 23.1  (22.7)
Colorectal-Anal Subscale - 6 Months 23.3  (24.1)
Colorectal-Anal Subscale - 12 Months 21.7  (22.6)
Colorectal-Anal Subscale - 24 Months 20.4  (22.9)
Colorectal-Anal Subscale - 36 Months 20.9  (22.1)
Urinary Subscale - Baseline 18.5  (23.6)
Urinary Subscale - 3 Months 12.7  (19.8)
Urinary Subscale - 6 Months 10.8  (18.3)
Urinary Subscale - 12 Months 11.3  (18.1)
Urinary Subscale - 24 Months 10.4  (17.7)
Urinary Subscale - 36 Months 11.8  (19.6)
POP Subscale - Baseline 9.8  (19.5)
POP Subscale - 3 Months 5.2  (11.8)
POP Subscale - 6 Months 5.8  (16.3)
POP Subscale - 12 Months 4.8  (12.7)
POP Subscale - 24 Months 4.5  (13.9)
POP Subscale - 36 Months 5.8  (14.5)
9.Secondary Outcome
Title Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Hide Description Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 32.2  (6.7)
3 Months 35.1  (6.1)
6 Months 35.0  (6.9)
12 Months 34.6  (7.1)
24 Months 33.9  (7.9)
36 Months 35.1  (7.8)
10.Secondary Outcome
Title Change in Numeric Pelvic Pain Scale (NPPS)
Hide Description Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.
Time Frame 12 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted at the time the NPPS was implemented in the study
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.8  (1.7)
Procedure 3.2  (2.5)
Acute Follow-up 1.0  (1.9)
3 Months 0.4  (1.1)
6 Months 0.7  (1.8)
12 Months 0.6  (1.6)
11.Other Pre-specified Outcome
Title Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)
Hide Description The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All implanted subjects
Arm/Group Title TOPAS
Hide Arm/Group Description:
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.4  (22.1)
12.Other Pre-specified Outcome
Title Change in Health Resource Usage: # Pads Per Day Subject Took for FI
Hide Description Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All implanted subjects
Arm/Group Title TOPAS
Hide Arm/Group Description:

TOPAS Treatment for Fecal Incontinence

TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.

Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: pads per day
# pads per day subject took for FI - Baseline 2.4  (2.1)
# per day subject took for FI - 12 Months 1.4  (1.8)
# pads per day subject took for FI - 24 Months 1.1  (1.5)
# pads per day subject took for FI - 36 Months 1.2  (1.6)
13.Other Pre-specified Outcome
Title Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
Hide Description Change in health resource usage using sponsor-created questionnaire
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All implanted subjects
Arm/Group Title TOPAS
Hide Arm/Group Description:

TOPAS Treatment for Fecal Incontinence

TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.

Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: days
# days in hospital due to FI - Baseline 0.1  (0.6)
# days in hospital due to FI - 12 Months 0.1  (0.5)
# days in hospital due to FI - 24 Months 0.0  (0.1)
# days in hospital due to FI - 36 Months 0.0  (0.0)
# days took off work due to FI - Baseline 6.4  (34.0)
# days took off work due to FI - 12 Months 1.3  (9.9)
# days took off work due to FI - 24 Months 4.5  (35.4)
# days took off work due to FI - 36 Months 0.9  (9.5)
# days others took off work - Baseline 0.2  (1.3)
# days others took off work - 12 Months 0.0  (0.0)
# days others took off work - 24 Months 0.0  (0.3)
# days others took off work - 36 Months 0.0  (0.0)
14.Other Pre-specified Outcome
Title Change in Health Resource Usage: # Physician Visits Due to FI
Hide Description Change in health resource usage using sponsor-created questionnaire
Time Frame 36 Month Follow-up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All implanted subjects
Arm/Group Title TOPAS
Hide Arm/Group Description:

TOPAS Treatment for Fecal Incontinence

TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.

Overall Number of Participants Analyzed 152
Mean (Standard Deviation)
Unit of Measure: physician visits
# physician visits due to FI - Baseline 5.0  (7.6)
# physician visits due to FI - 12 Months 0.4  (1.4)
# physician visits due to FI - 24 Months 0.5  (1.8)
# physician visits due to FI - 36 Months 0.3  (1.1)
Time Frame AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
Adverse Event Reporting Description An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
 
Arm/Group Title TOPAS
Hide Arm/Group Description TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
All-Cause Mortality
TOPAS
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
TOPAS
Affected / at Risk (%) # Events
Total   8/152 (5.26%)    
Infections and infestations   
Methicillin-resistant staphylococcus aureus infection  [1]  1/152 (0.66%)  1
Musculoskeletal and connective tissue disorders   
Pain/discomfort - buttock  [2]  1/152 (0.66%)  1
Psychiatric disorders   
Exacerbated post traumatic stress disorder   1/152 (0.66%)  1
Reproductive system and breast disorders   
Worsening Pelvic Organ Prolapse  [3]  1/152 (0.66%)  1
De novo pelvic organ prolapse  [4]  1/152 (0.66%)  1
De novo rectal prolapse  [5]  1/152 (0.66%)  1
Respiratory, thoracic and mediastinal disorders   
Worsening chronic obstructive pulmonary disease   1/152 (0.66%)  1
Vascular disorders   
Deep vein thrombosis   1/152 (0.66%)  1
Indicates events were collected by systematic assessment
[1]
Hospital acquired - Left hand
[2]
Exacerbation of sciatic pain
[3]
Recurrent rectal prolapse
[4]
Mild cystocele / enterocele / rectocele
[5]
Mucosal prolapse
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TOPAS
Affected / at Risk (%) # Events
Total   72/152 (47.37%)    
Gastrointestinal disorders   
Defecatory problems  [1]  4/152 (2.63%)  4
Infections and infestations   
Infection  [2]  22/152 (14.47%)  25
Injury, poisoning and procedural complications   
Bleeding   1/152 (0.66%)  1
Other  [3]  14/152 (9.21%)  14
Renal and urinary disorders   
Urinary problems  [4]  8/152 (5.26%)  8
Reproductive system and breast disorders   
Pelvic area pain  [5]  43/152 (28.29%)  50
Pelvic organ prolapse  [6]  9/152 (5.92%)  13
Indicates events were collected by systematic assessment
[1]
includes worsening fecal incontinence and constipation
[2]
Includes incision site infection, abscess, UTIs, and fungal infections
[3]
Includes Allergic Reaction / Hypersensitivity Reaction, Diarrhea, Headache, Deep Venous Thrombosis, COPD, Nausea, Post-Traumatic Stress Disorder, Rectal Discharge, Skin Irritation, and Wound Dehiscence
[4]
Includes de novo and worsening urinary incontinence and retention
[5]
Pain/discomfort in the general pelvic region including the buttocks, groin, pelvis, upper leg, urogenitals and abdomen.
[6]
Includes de novo and worsening vaginal and rectal prolapse
Study was a single arm trial with no control group. Study was done with a very specialized group of clinical investigators from two medical sub-specialties, Colorectal Surgeons and Urogynecologists. Study population was primarily Caucasian (90%).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.

After the primary or the combined data article has been published, an Investigator may publish the study experience from his/her site. However, the Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data.

All publications will be reviewed by the sponsor in order to assure that no confidential information is disclosed. Such confidential information is not allowed for publishing.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dee Fenner, MD, Study Coordinating Investigator
Organization: University of Michigan, Professor of Obstetrics and Gynecology
Phone: 734-647-5866
EMail: deef@med.umich.edu
Layout table for additonal information
Responsible Party: ASTORA Women's Health
ClinicalTrials.gov Identifier: NCT01090739    
Other Study ID Numbers: WC0807
First Submitted: March 19, 2010
First Posted: March 22, 2010
Results First Submitted: April 19, 2016
Results First Posted: August 26, 2016
Last Update Posted: August 26, 2016