Vesico-vaginal Fistula
Conditions
Keywords
fistula, vesico-vaginal fistula
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.
Interventions
DEVICESurgisis Biodesign (Vesico-vaginal fistula plug)
Vesico-vaginal fistula plug
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fistula | 4 months |
| Adverse Events | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life | 4 months |
Countries
Uganda
Outcome results
None listed