Phase 2
N=29
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00565136 ↗Enrolled (actual)
29
Serious AEs
17.2%
Results posted
Aug 2013
Primary outcome: Primary: Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment — 6.9; 3.0; 3.7; 3.7 Number of FI episodes/14 day period
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TOPAS (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- ASTORA Women's Health
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment |
6.9; 3.0; 3.7; 3.7; 3.1; 3.5 | — |
| SECONDARY Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period |
2.34; 0.66; 0.17; 0.03 | — |
| SECONDARY Fecal Incontinence Symptoms as Measured by the Wexner Score |
13.2; 7.6; 7.5; 8.5; 8.7; 9.9 | — |
| SECONDARY Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence |
10.1; 7.4; 7.2; 7.5; 8.0; 8.1 | — |
| SECONDARY Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life |
2.7; 3.3; 3.2; 3.3; 3.3; 2.7 | — |
| SECONDARY Pain Intensity as Measured by the Pain Intensity Scale |
1.0; 0.4 | — |
| SECONDARY Intra- and Peri-Surgical Parameters: Length of Procedure |
23 | — |
| SECONDARY Intra- and Peri-Surgical Parameters: Length of Hospital Stay |
22.6 | — |
| SECONDARY Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure |
15 | — |
Summary
The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence
Eligibility Criteria
Inclusion Criteria
- Females at least 21 years of age who have evidence of pelvic floor weakness
- Females who attempted but not been satisfied with conservative therapies such as dietary changes, dietary bulking agents, biofeedback, etc.
- Subjects, who have an external anal injury, must have some voluntary sphincter control
Exclusion Criteria
- Subjects who are unwilling or unable to sign an Informed Consent form
- Subjects who are currently pregnant or considering future child-bearing
- Subjects who are contraindicated for surgery
- Subjects who are allergic to polypropylene mesh
- Subjects who are enrolled in a concurrent clinical trial
- Subjects with previous implantation of mesh or trauma to the pelvic area
- Subjects who engage in anal receptive intercourse
- Subjects with a significant evacuation disorder such as chronic constipation
- Subjects with Crohn's Disease, ulcerative colitis or chronic diarrhea as the primary cause for fecal incontinence
- Subjects who had a hysterectomy within 6 months prior to enrollment
- Subjects with vaginal prolapse that passes the hymen
- Subjects with complete rectal prolapse
- Subjects with a history of pelvic radiation that compromises the anal canal
- Subjects who have psychiatric disturbance or debilitation as a possible cause for fecal incontinence
- Subjects with a neurological disorder such as amyotrophic lateral sclerosis, multiple sclerosis, or brain tumor as a possible cause for fecal incontinence symptoms
- Subjects with an active pelvic infection or a recto-vaginal fistula
- Subjects who have not had a negative screening exam for colon cancer within 10 years of enrollment
- Subjects who have other inappropriate conditions as determined by the physician
Data sourced from ClinicalTrials.gov (NCT00565136). 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.