Fecal Incontinence
Conditions
Keywords
Fecal incontinence, Accidental bowel leakage, Failure conservative therapy, Women, Class III medical device, Surgical mesh
Brief summary
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
Detailed description
This is a prospective, multi-center, single-arm, open-label, two- stage, adaptive study conducted to obtain data to demonstrate the safety and effectiveness of the TOPAS system for the treatment of FI in women who have failed conservative therapy. It was approved by the FDA for up to 152 implanted subjects at up to 15 investigational sites in the US. Eight study centers are led by a Colorectal Surgeon and seven centers are led by an Urogynecologist. This study is being conducted in compliance with Title 21 CFR Parts 11, 50, 54, 56, and 812; the principles of GCP as set forth in the World Medical Association Declaration of Helsinki (2008); and the ISO standard 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice).
Interventions
DEVICETOPAS 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.
Sponsors
ASTORA Women's Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject is/has: 1. An adult (\>/= 18 years) female. 2. FI symptoms for a minimum of 6 months. 3. Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training. 4. \<50 years old OR if \>/= 50 years old, has had a negative cancer screening examination of the colon according screening guidelines (colonoscopy or barium enema + flexible sigmoidoscopy) within the past 3 years prior to informed consent date. (Note: if not done, the investigating physician must provide written justification for not having this exam and must be following the American Cancer Society Guidelines). 5. FI episodes ≥ 4 in 14 day period.
Exclusion criteria
Subject is/has 1. Unable or unwilling to sign Informed Consent Form or comply with study requirements. 2. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by AMS. 3. Allergic to polypropylene. 4. Pregnant or planning a future pregnancy. 5. Less than 12 months (365 days) postpartum. 6. Pelvic prolapse \>/=1 cm beyond the hymen (Stage III & IV) 7. Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation. 8. Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation. 9. Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation. 10. Planning pelvic surgery within 12 months (365 days) post implant 11. Current Grade III or IV hemorrhoids. 12. Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor. 13. Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease). 14. Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. 15. Severe chronic constipation, including obstructive defecatory disorder. 16. External full thickness rectal prolapse. 17. A history of laxative abuse within the past 5 years. 18. Had previous rectal resection. 19. Active pelvic infection, perianal or recto-vaginal fistula. 20. Congenital anorectal malformations or chronic 4th degree lacerations and cloacae. 21. History of therapeutic radiation for cancers of the pelvis. 22. Currently implanted with a sacral nerve stimulator. 23. Contraindicated for surgery or having any condition that would compromise wound healing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders | 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wexner Symptom Severity Score | 36 Month Follow-up Visit | 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. |
| Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | 36 Month Follow-up Visit | 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. |
| Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | 36 Month Follow-up Visit | 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. |
| Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | 36 Month Follow-up Visit | 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. |
| Change in Numeric Pelvic Pain Scale (NPPS) | 12 Month Follow-up Visit | 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. |
| Change in Fecal Incontinence Episodes | 36 Month Follow-up Visit | Number of fecal incontinence episodes in a 14 day period |
| Change in Fecal Incontinence Days | 36 Month Follow-up Visit | Number of fecal incontinence days in a 14 day period |
| Change in Urge Fecal Incontinence Episodes | 36 Month Follow-up Visit | Number of urge fecal incontinence episodes in a 14 day period |
| Change in Fecal Incontinence Quality of Life Score | 36 Month Follow-up Visit | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | 36 Month Follow-up Visit | Change in health resource usage using sponsor-created questionnaire |
| Change in Health Resource Usage: # Physician Visits Due to FI | 36 Month Follow-up Visit | Change in health resource usage using sponsor-created questionnaire |
| Change in Health Resource Usage: # Pads Per Day Subject Took for FI | 36 Month Follow-up Visit | Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI |
| Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8) | 36 Month Follow-up Visit | 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 |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| TOPAS 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. | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12 Month Follow-up | Death | 1 |
| 12 Month Follow-up | Lost to Follow-up | 1 |
| 12 Month Follow-up | Physician Decision | 1 |
| 12 Month Follow-up | Withdrawal by Subject | 2 |
| 24 Month Follow-up | Death | 1 |
| 24 Month Follow-up | Lost to Follow-up | 1 |
| 24 Month Follow-up | Withdrawal by Subject | 7 |
| 36 Month Follow-up | Visit still pending | 17 |
| 36 Month Follow-up | Withdrawal by Subject | 6 |
| Enrollment | Adverse Event | 1 |
| Enrollment | Lost to Follow-up | 5 |
| Enrollment | Physician Decision | 5 |
| Enrollment | Protocol Violation | 14 |
| Enrollment | Sponsor termination of site | 4 |
| Enrollment | Study implant limit reached | 2 |
| Enrollment | Withdrawal by Subject | 24 |
Baseline characteristics
| Characteristic | TOPAS |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 9.7 |
| Anal Resting Tone Absent | 11 participants |
| Anal Resting Tone Present | 141 participants |
| Anorectal Manometry - Pressures Mean Maximum Resting Pressure | 31.5 mmHg STANDARD_DEVIATION 21.9 |
| Anorectal Manometry - Pressures Mean Maximum Squeeze Pressure | 60.1 mmHg STANDARD_DEVIATION 42.6 |
| Anorectal Manometry - Volumes First sensation volume | 43.1 cc STANDARD_DEVIATION 30.9 |
| Anorectal Manometry - Volumes Maximum tolerated volume | 124.8 cc STANDARD_DEVIATION 61.9 |
| Baseline Fecal Incontinence Medication Anti-cholinergic agents | 6 participants |
| Baseline Fecal Incontinence Medication Bile acid sequestrants | 3 participants |
| Baseline Fecal Incontinence Medication Bulking agents | 22 participants |
| Baseline Fecal Incontinence Medication Opioid-receptor agents | 30 participants |
| Baseline Fecal Incontinence Medication Osmotic laxatives | 8 participants |
| Baseline Fecal Incontinence Medication Other meds | 5 participants |
| Baseline Medical History Depressive disorder | 56 participants |
| Baseline Medical History Diabetes | 19 participants |
| Baseline Medical History Diverticulitis | 41 participants |
| Baseline Medical History Gallstones | 2 participants |
| Baseline Medical History Gastrointestional reflux disease | 65 participants |
| Baseline Medical History Headaches | 29 participants |
| Baseline Medical History Hemorrhoids | 36 participants |
| Baseline Medical History Hyperlipidemia | 53 participants |
| Baseline Medical History Hypertension | 60 participants |
| Baseline Medical History Hypothroid | 38 participants |
| Baseline Medical History Irritable bowel syndrome | 31 participants |
| Baseline Medical History Pelvic area pain | 52 participants |
| Baseline Medical History Previous anal sphincter repair | 31 participants |
| Baseline Medical History Previous cholecystectomy | 38 participants |
| Baseline Medical History Previous hysterectomy / oophorectomy | 74 participants |
| Baseline Medical History Previous prolapse / UI repair | 70 participants |
| Baseline Medical History Rectal prolapse | 6 participants |
| Baseline Medical History Systemic pain | 55 participants |
| Baseline Medical History Urinary incontinence | 39 participants |
| Baseline Medical History Vaginal atrophy | 23 participants |
| Baseline Medical History Vaginal prolapse | 8 participants |
| Concomitant Use # Caffeine use on a regular basis | 102 participants |
| Concomitant Use # Rgular laxative use within past 5 years | 18 participants |
| Concomitant Use # Smoked within past 6 months | 8 participants |
| Duration of Fecal Incontinence | 110.0 months STANDARD_DEVIATION 113.5 |
| Etiology of Fecal Incontinence Anorectal trauma | 6 participants |
| Etiology of Fecal Incontinence Idiopathic/unknown | 62 participants |
| Etiology of Fecal Incontinence Obstetric trauma | 87 participants |
| Etiology of Fecal Incontinence Other | 4 participants |
| External Anal Sphincter Defect Extent | 95.3 degrees STANDARD_DEVIATION 45 |
| External Anal Sphincter Defects Absent | 73 participants |
| External Anal Sphincter Defects Present | 79 participants |
| Failed Fecal Incontinence Conservative Therapy Diet, medication and pelvic floor training | 61 participants |
| Failed Fecal Incontinence Conservative Therapy Diet modification and medication | 22 participants |
| Failed Fecal Incontinence Conservative Therapy Diet modification and pelvic floor muscle training | 49 participants |
| Failed Fecal Incontinence Conservative Therapy Medication and pelvic floor muscle training | 20 participants |
| Hemorrhoids Absent | 118 participants |
| Hemorrhoids Present | 34 participants |
| Internal Anal Sphincter Defect Extent | 110.0 degrees STANDARD_DEVIATION 53.7 |
| Internal Anal Sphincter Defects Absent | 110 participants |
| Internal Anal Sphincter Defects Present | 42 participants |
| Menopausal Status Peri-menopausal | 6 participants |
| Menopausal Status Post-menopausal | 126 participants |
| Menopausal Status Pre-menopausal | 20 participants |
| Obstetric History - Gravidity | 3.0 number STANDARD_DEVIATION 1.8 |
| Obstetric History - # of Caesarean deliveries | 0.1 number STANDARD_DEVIATION 0.5 |
| Obstetric History - # of Vaginal Deliveries | 2.4 number STANDARD_DEVIATION 1.5 |
| Obstetric History - Parity | 2.6 number STANDARD_DEVIATION 1.4 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black or African American | 10 participants |
| Race/Ethnicity, Customized Hispanic/Latina | 3 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White/Caucasian | 137 participants |
| Rectal soft tissue scarring Absent | 126 participants |
| Rectal soft tissue scarring Present | 26 participants |
| Region of Enrollment United States | 152 participants |
| Sex/Gender, Customized Women | 152 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 72 / 152 |
| serious Total, serious adverse events | 8 / 152 |
Outcome results
Primary
Percentage of Responders
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
Population: All subjects implanted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TOPAS | Percentage of Responders | 69.1 percentage of treatment responders |
Secondary
Change in Fecal Incontinence Days
Number of fecal incontinence days in a 14 day period
Time frame: 36 Month Follow-up Visit
Population: All subjects implanted
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TOPAS | Change in Fecal Incontinence Days | Baseline | 10 fecal incontinent days/14 days |
| TOPAS | Change in Fecal Incontinence Days | 3 Months | 4 fecal incontinent days/14 days |
| TOPAS | Change in Fecal Incontinence Days | 6 Months | 4 fecal incontinent days/14 days |
| TOPAS | Change in Fecal Incontinence Days | 12 Months | 4 fecal incontinent days/14 days |
| TOPAS | Change in Fecal Incontinence Days | 24 Months | 4 fecal incontinent days/14 days |
| TOPAS | Change in Fecal Incontinence Days | 36 Months | 4 fecal incontinent days/14 days |
Secondary
Change in Fecal Incontinence Episodes
Number of fecal incontinence episodes in a 14 day period
Time frame: 36 Month Follow-up Visit
Population: All subjects implanted
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TOPAS | Change in Fecal Incontinence Episodes | Baseline | 18 fecal incontinent episodes/14 days |
| TOPAS | Change in Fecal Incontinence Episodes | 3 Months | 5 fecal incontinent episodes/14 days |
| TOPAS | Change in Fecal Incontinence Episodes | 6 Months | 5 fecal incontinent episodes/14 days |
| TOPAS | Change in Fecal Incontinence Episodes | 12 Months | 5 fecal incontinent episodes/14 days |
| TOPAS | Change in Fecal Incontinence Episodes | 24 Months | 5 fecal incontinent episodes/14 days |
| TOPAS | Change in Fecal Incontinence Episodes | 36 Months | 5 fecal incontinent episodes/14 days |
Secondary
Change in Fecal Incontinence Quality of Life Score
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
Population: All subjects implanted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Lifestyle - Baseline | 2.6 units on a scale | Standard Deviation 0.8 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Lifestyle - 3 Months | 3.3 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Lifestyle - 6 Months | 3.3 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Lifestyle - 12 Months | 3.4 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Lifestyle - 24 Months | 3.4 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Lifestyle - 36 Months | 3.4 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Coping - Baseline | 1.7 units on a scale | Standard Deviation 0.6 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Coping - 3 Months | 2.6 units on a scale | Standard Deviation 0.8 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Coping - 6 Months | 2.6 units on a scale | Standard Deviation 0.9 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Coping - 12 Months | 2.7 units on a scale | Standard Deviation 0.9 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Coping - 24 Months | 2.7 units on a scale | Standard Deviation 0.9 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Coping - 36 Months | 2.7 units on a scale | Standard Deviation 0.9 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Depression - Baseline | 2.4 units on a scale | Standard Deviation 0.6 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Depression - 3 Months | 3.0 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Depression - 6 Months | 3.1 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Depression - 12 Months | 3.1 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Depression - 24 Months | 3.1 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Depression - 36 Months | 3.2 units on a scale | Standard Deviation 0.7 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Embarrassment - Baseline | 1.6 units on a scale | Standard Deviation 0.6 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Embarrassment - 3 Months | 2.5 units on a scale | Standard Deviation 0.9 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Embarrassment - 6 Months | 2.6 units on a scale | Standard Deviation 1 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Embarrassment - 12 Months | 2.7 units on a scale | Standard Deviation 0.9 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Embarrassment - 24 Months | 2.7 units on a scale | Standard Deviation 0.9 |
| TOPAS | Change in Fecal Incontinence Quality of Life Score | Embarrassment - 36 Months | 2.7 units on a scale | Standard Deviation 0.9 |
Secondary
Change in Numeric Pelvic Pain Scale (NPPS)
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
Population: All subjects implanted at the time the NPPS was implemented in the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Numeric Pelvic Pain Scale (NPPS) | Baseline | 0.8 units on a scale | Standard Deviation 1.7 |
| TOPAS | Change in Numeric Pelvic Pain Scale (NPPS) | Procedure | 3.2 units on a scale | Standard Deviation 2.5 |
| TOPAS | Change in Numeric Pelvic Pain Scale (NPPS) | Acute Follow-up | 1.0 units on a scale | Standard Deviation 1.9 |
| TOPAS | Change in Numeric Pelvic Pain Scale (NPPS) | 3 Months | 0.4 units on a scale | Standard Deviation 1.1 |
| TOPAS | Change in Numeric Pelvic Pain Scale (NPPS) | 6 Months | 0.7 units on a scale | Standard Deviation 1.8 |
| TOPAS | Change in Numeric Pelvic Pain Scale (NPPS) | 12 Months | 0.6 units on a scale | Standard Deviation 1.6 |
Secondary
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
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
Population: All subjects implanted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Colorectal-Anal Subscale - 3 Months | 33.3 units on a scale | Standard Deviation 17.7 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | POP Subscale - 12 Months | 12.8 units on a scale | Standard Deviation 13.9 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Total PFDI Score - Baseline | 104.1 units on a scale | Standard Deviation 47.4 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Total PFDI Score - 3 Months | 69.7 units on a scale | Standard Deviation 43.1 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Total PFDI Score - 6 Months | 68.8 units on a scale | Standard Deviation 45.9 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Total PFDI Score - 12 Months | 66.7 units on a scale | Standard Deviation 43.4 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Total PFDI Score - 24 Months | 65.7 units on a scale | Standard Deviation 43.9 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Total PFDI Score - 36 Months | 70.3 units on a scale | Standard Deviation 51.2 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Colorectal-Anal Subscale - Baseline | 54.8 units on a scale | Standard Deviation 16.2 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Colorectal-Anal Subscale - 6 Months | 33.0 units on a scale | Standard Deviation 19.8 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Colorectal-Anal Subscale - 12 Months | 32.1 units on a scale | Standard Deviation 19.2 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Colorectal-Anal Subscale - 24 Months | 31.5 units on a scale | Standard Deviation 19.7 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Colorectal-Anal Subscale - 36 Months | 33.5 units on a scale | Standard Deviation 21 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Urinary Subscale - Baseline | 27.2 units on a scale | Standard Deviation 25.1 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Urinary Subscale - 3 Months | 21.4 units on a scale | Standard Deviation 21.5 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Urinary Subscale - 6 Months | 21.4 units on a scale | Standard Deviation 22.7 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Urinary Subscale - 12 Months | 21.5 units on a scale | Standard Deviation 21.9 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Urinary Subscale - 24 Months | 22.2 units on a scale | Standard Deviation 22.1 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | POP Subscale - 36 Months | 13.8 units on a scale | Standard Deviation 16.9 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | Urinary Subscale - 36 Months | 22.6 units on a scale | Standard Deviation 23 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | POP Subscale - Baseline | 21.9 units on a scale | Standard Deviation 19.5 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | POP Subscale - 3 Months | 14.9 units on a scale | Standard Deviation 15.6 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | POP Subscale - 6 Months | 14.2 units on a scale | Standard Deviation 14.9 |
| TOPAS | Change in Pelvic Floor Distress Inventory (PFDI-20) Scores | POP Subscale - 24 Months | 12.1 units on a scale | Standard Deviation 13.8 |
Secondary
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
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
Population: All subjects implanted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Total PDFI Score - Baseline | 79.6 units on a scale | Standard Deviation 52.3 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Total PDFI Score - 3 Months | 41.0 units on a scale | Standard Deviation 43.5 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Total PDFI Score - 6 Months | 39.6 units on a scale | Standard Deviation 48.4 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Total PDFI Score - 12 Months | 37.9 units on a scale | Standard Deviation 43.5 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Total PDFI Score - 24 Months | 35.2 units on a scale | Standard Deviation 45.5 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Total PDFI Score - 36 Months | 38.5 units on a scale | Standard Deviation 48.5 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Colorectal-Anal Subscale - Baseline | 51.7 units on a scale | Standard Deviation 25.5 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Colorectal-Anal Subscale - 3 Months | 23.1 units on a scale | Standard Deviation 22.7 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Colorectal-Anal Subscale - 6 Months | 23.3 units on a scale | Standard Deviation 24.1 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Colorectal-Anal Subscale - 12 Months | 21.7 units on a scale | Standard Deviation 22.6 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Colorectal-Anal Subscale - 24 Months | 20.4 units on a scale | Standard Deviation 22.9 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Colorectal-Anal Subscale - 36 Months | 20.9 units on a scale | Standard Deviation 22.1 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Urinary Subscale - Baseline | 18.5 units on a scale | Standard Deviation 23.6 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Urinary Subscale - 3 Months | 12.7 units on a scale | Standard Deviation 19.8 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Urinary Subscale - 6 Months | 10.8 units on a scale | Standard Deviation 18.3 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Urinary Subscale - 12 Months | 11.3 units on a scale | Standard Deviation 18.1 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Urinary Subscale - 24 Months | 10.4 units on a scale | Standard Deviation 17.7 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | Urinary Subscale - 36 Months | 11.8 units on a scale | Standard Deviation 19.6 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | POP Subscale - Baseline | 9.8 units on a scale | Standard Deviation 19.5 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | POP Subscale - 3 Months | 5.2 units on a scale | Standard Deviation 11.8 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | POP Subscale - 6 Months | 5.8 units on a scale | Standard Deviation 16.3 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | POP Subscale - 12 Months | 4.8 units on a scale | Standard Deviation 12.7 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | POP Subscale - 24 Months | 4.5 units on a scale | Standard Deviation 13.9 |
| TOPAS | Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores | POP Subscale - 36 Months | 5.8 units on a scale | Standard Deviation 14.5 |
Secondary
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
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
Population: All subjects implanted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | Baseline | 32.2 units on a scale | Standard Deviation 6.7 |
| TOPAS | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | 3 Months | 35.1 units on a scale | Standard Deviation 6.1 |
| TOPAS | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | 6 Months | 35.0 units on a scale | Standard Deviation 6.9 |
| TOPAS | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | 12 Months | 34.6 units on a scale | Standard Deviation 7.1 |
| TOPAS | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | 24 Months | 33.9 units on a scale | Standard Deviation 7.9 |
| TOPAS | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | 36 Months | 35.1 units on a scale | Standard Deviation 7.8 |
Secondary
Change in Urge Fecal Incontinence Episodes
Number of urge fecal incontinence episodes in a 14 day period
Time frame: 36 Month Follow-up Visit
Population: All subjects implanted
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TOPAS | Change in Urge Fecal Incontinence Episodes | Baseline | 4 urge fecal incontinent episodes/14 days |
| TOPAS | Change in Urge Fecal Incontinence Episodes | 3 Months | 0 urge fecal incontinent episodes/14 days |
| TOPAS | Change in Urge Fecal Incontinence Episodes | 6 Months | 0 urge fecal incontinent episodes/14 days |
| TOPAS | Change in Urge Fecal Incontinence Episodes | 12 Months | 0 urge fecal incontinent episodes/14 days |
| TOPAS | Change in Urge Fecal Incontinence Episodes | 24 Months | 0 urge fecal incontinent episodes/14 days |
| TOPAS | Change in Urge Fecal Incontinence Episodes | 36 Months | 0 urge fecal incontinent episodes/14 days |
Secondary
Change in Wexner Symptom Severity Score
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
Population: All subjects implanted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Wexner Symptom Severity Score | Baseline | 13.9 units on a scale | Standard Deviation 2.7 |
| TOPAS | Change in Wexner Symptom Severity Score | 3 Months | 9.4 units on a scale | Standard Deviation 4.3 |
| TOPAS | Change in Wexner Symptom Severity Score | 6 Months | 9.8 units on a scale | Standard Deviation 4.4 |
| TOPAS | Change in Wexner Symptom Severity Score | 12 Months | 9.6 units on a scale | Standard Deviation 3.9 |
| TOPAS | Change in Wexner Symptom Severity Score | 24 Months | 9.5 units on a scale | Standard Deviation 4.2 |
| TOPAS | Change in Wexner Symptom Severity Score | 36 Months | 9.4 units on a scale | Standard Deviation 4.3 |
Other Pre-specified
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
Change in health resource usage using sponsor-created questionnaire
Time frame: 36 Month Follow-up Visit
Population: All implanted subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days in hospital due to FI - Baseline | 0.1 days | Standard Deviation 0.6 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days in hospital due to FI - 12 Months | 0.1 days | Standard Deviation 0.5 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days in hospital due to FI - 24 Months | 0.0 days | Standard Deviation 0.1 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days in hospital due to FI - 36 Months | 0.0 days | Standard Deviation 0 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days took off work due to FI - Baseline | 6.4 days | Standard Deviation 34 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days took off work due to FI - 12 Months | 1.3 days | Standard Deviation 9.9 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days took off work due to FI - 24 Months | 4.5 days | Standard Deviation 35.4 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days took off work due to FI - 36 Months | 0.9 days | Standard Deviation 9.5 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days others took off work - Baseline | 0.2 days | Standard Deviation 1.3 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days others took off work - 12 Months | 0.0 days | Standard Deviation 0 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days others took off work - 24 Months | 0.0 days | Standard Deviation 0.3 |
| TOPAS | Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI | # days others took off work - 36 Months | 0.0 days | Standard Deviation 0 |
Other Pre-specified
Change in Health Resource Usage: # Pads Per Day Subject Took for FI
Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI
Time frame: 36 Month Follow-up Visit
Population: All implanted subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Health Resource Usage: # Pads Per Day Subject Took for FI | # pads per day subject took for FI - Baseline | 2.4 pads per day | Standard Deviation 2.1 |
| TOPAS | Change in Health Resource Usage: # Pads Per Day Subject Took for FI | # per day subject took for FI - 12 Months | 1.4 pads per day | Standard Deviation 1.8 |
| TOPAS | Change in Health Resource Usage: # Pads Per Day Subject Took for FI | # pads per day subject took for FI - 24 Months | 1.1 pads per day | Standard Deviation 1.5 |
| TOPAS | Change in Health Resource Usage: # Pads Per Day Subject Took for FI | # pads per day subject took for FI - 36 Months | 1.2 pads per day | Standard Deviation 1.6 |
Other Pre-specified
Change in Health Resource Usage: # Physician Visits Due to FI
Change in health resource usage using sponsor-created questionnaire
Time frame: 36 Month Follow-up Visit
Population: All implanted subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TOPAS | Change in Health Resource Usage: # Physician Visits Due to FI | # physician visits due to FI - Baseline | 5.0 physician visits | Standard Deviation 7.6 |
| TOPAS | Change in Health Resource Usage: # Physician Visits Due to FI | # physician visits due to FI - 12 Months | 0.4 physician visits | Standard Deviation 1.4 |
| TOPAS | Change in Health Resource Usage: # Physician Visits Due to FI | # physician visits due to FI - 24 Months | 0.5 physician visits | Standard Deviation 1.8 |
| TOPAS | Change in Health Resource Usage: # Physician Visits Due to FI | # physician visits due to FI - 36 Months | 0.3 physician visits | Standard Deviation 1.1 |
Other Pre-specified
Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)
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
Population: All implanted subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TOPAS | Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8) | 79.4 units on a scale | Standard Deviation 22.1 |