N/A
N=207
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01090739 ↗Enrolled (actual)
207
Serious AEs
5.3%
Results posted
Aug 2016
Primary outcome: Primary: Percentage of Responders — 69.1 percentage of treatment responders
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TOPAS Treatment for Fecal Incontinence (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- ASTORA Women's Health
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders |
69.1 | — |
| SECONDARY Change in Fecal Incontinence Episodes |
18; 5; 5; 5; 5; 5 | — |
| SECONDARY Change in Fecal Incontinence Days |
10; 4; 4; 4; 4; 4 | — |
| SECONDARY Change in Urge Fecal Incontinence Episodes |
4; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Wexner Symptom Severity Score |
13.9; 9.4; 9.8; 9.6; 9.5; 9.4 | — |
| SECONDARY Change in Fecal Incontinence Quality of Life Score |
2.6; 3.3; 3.3; 3.4; 3.4; 3.4 | — |
| SECONDARY Change in Pelvic Floor Distress Inventory (PFDI-20) Scores |
104.1; 69.7; 68.8; 66.7; 65.7; 70.3 | — |
| SECONDARY Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores |
79.6; 41.0; 39.6; 37.9; 35.2; 38.5 | — |
| SECONDARY Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) |
32.2; 35.1; 35.0; 34.6; 33.9; 35.1 | — |
| SECONDARY Change in Numeric Pelvic Pain Scale (NPPS) |
0.8; 3.2; 1.0; 0.4; 0.7; 0.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
Subject is/has:
- An adult (>/= 18 years) female.
- FI symptoms for a minimum of 6 months.
- Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training.
- /= 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).
- FI episodes ≥ 4 in 14 day period.
Exclusion Criteria
Subject is/has
- Unable or unwilling to sign Informed Consent Form or comply with study requirements.
- 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.
- Allergic to polypropylene.
- Pregnant or planning a future pregnancy.
- Less than 12 months (365 days) postpartum.
- Pelvic prolapse >/=1 cm beyond the hymen (Stage III & IV)
- Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation.
- Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation.
- Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation.
- Planning pelvic surgery within 12 months (365 days) post implant
- Current Grade III or IV hemorrhoids.
- Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor.
- Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease).
- Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence.
- Severe chronic constipation, including obstructive defecatory disorder.
- External full thickness rectal prolapse.
- A history of laxative abuse within the past 5 years.
- Had previous rectal resection.
- Active pelvic infection, perianal or recto-vaginal fistula.
- Congenital anorectal malformations or chronic 4th degree lacerations and cloacae.
- History of therapeutic radiation for cancers of the pelvis.
- Currently implanted with a sacral nerve stimulator.
- Contraindicated for surgery or having any condition that would compromise wound healing.
Data sourced from ClinicalTrials.gov (NCT01090739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.