Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

Study Overview
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Brief Summary
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This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.

Official Title
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Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

Conditions
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Vesico-vaginal Fistula

Intervention / Treatment
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* Device: Surgisis Biodesign (Vesico-vaginal fistula plug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has signed and dated the informed consent. Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent. Patient agrees to follow-up schedule. Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess. Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device. Exclusion Criteria: Patient is not medically fit enough for surgery under general or spinal anesthesia. Patient is a mature minor as defined by Ugandan law. Patient is pregnant, breastfeeding or planning further pregnancy during the study period. Patient has physical allergies or cultural objections to the receipt of porcine products. Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing. Patient has spina bifida or other neural tube defect. Patient has interstitial cystitis or other chronic pelvic pain syndrome. Patient has signs of acute or chronic pelvic inflammation, active urinary tract infection not responsive to antibiotic treatment, vaginal infection, or abscess of the fistula tract. Patient presents with clinically diagnosed sepsis (for whatever reason). Patient has concomitant ureterovaginal fistula.

Ages Eligible for Study
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Minimum Age: 10 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vesico-vaginal fistula plug<br>Vesico-vaginal fistula plug | Device: Surgisis Biodesign (Vesico-vaginal fistula plug)<br>* Vesico-vaginal fistula plug<br>* Other names: SurgiSIS Biodesign;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula |  | 4 months | 
| Adverse Events |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fistula, vesico-vaginal fistula