Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

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.

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.