Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug (VVP)

Cook Group

Status

Completed

Conditions

Vesico-vaginal Fistula

Treatments

Device: Surgisis Biodesign (Vesico-vaginal fistula plug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00923338

09-006

350012

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

10+ years old

Volunteers

No Healthy Volunteers

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.