Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
Not Applicable
Completed
- Conditions
- Vesico-vaginal Fistula
- Interventions
- Device: Surgisis Biodesign (Vesico-vaginal fistula plug)
- Registration Number
- NCT00923338
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vesico-vaginal fistula plug Surgisis Biodesign (Vesico-vaginal fistula plug) Vesico-vaginal fistula plug
- Primary Outcome Measures
Name Time Method Adverse Events 4 months Fistula 4 months
- Secondary Outcome Measures
Name Time Method Improvement in quality of life 4 months
Trial Locations
- Locations (1)
Mbarara University Teaching Hospital
🇺🇬Mbarara, Uganda