Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

Not Applicable

Completed

• Conditions: Vesico-vaginal Fistula

• 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

Study Timeline

• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Study Start: 2009-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-31

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

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