Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.

Official Title
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Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

Conditions
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Fecal Incontinence, Anal Incontinence

Intervention / Treatment
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* Device: Biodesign Tissue Repair Graft
* Other: Overlapping Sphincter Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age 18 years or older fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles Fecal incontinence severity score of 10 or more Fecal incontinence episodes of 4 or more over a 2 week period Exclusion Criteria: History of diabetes History of allergy to porcine derivatives History of infection in the anal area (abscess, fistula) History of inflammatory bowel disease History of hidradenitis suppurativa History of immunosuppression History of HIV positivity History of radiation to the study site within the last 12 months Patients who cannot travel to keep follow up appointments Patients who are prisoners Patients who are mentally handicapped Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment. Patients with a FIQL baseline score of ≤ 4 Patients participating in another clinical trial for the same indication Patients unwilling to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodesign Tissue Repair Graft<br>Biodesign Tissue Repair Graft | Device: Biodesign Tissue Repair Graft<br>* Biodesign Tissue Repair Graft reinforcement<br>Other: Overlapping Sphincter Repair<br>* Overlapping Sphincter Repair Alone<br>|
| Active Comparator: Overlapping Sphincter Repair<br>Control | Other: Overlapping Sphincter Repair<br>* Overlapping Sphincter Repair Alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting a Decrease in Incontinence Episodes Per Week |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting a Decrease in Incontinence Episodes Per Week |  | 24 months |