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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00923338
First received: June 16, 2009
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Vesico-vaginal Fistula
Device: Surgisis Biodesign (Vesico-vaginal fistula plug)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Fistula [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vesico-vaginal fistula plug
Vesico-vaginal fistula plug
Device: Surgisis Biodesign (Vesico-vaginal fistula plug)
Vesico-vaginal fistula plug
Other Name: SurgiSIS Biodesign

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923338

Locations
Uganda
Mbarara University Teaching Hospital
Mbarara, Uganda
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Musa Kayondo, MD Mbarara University Teaching Hospital
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00923338     History of Changes
Other Study ID Numbers: 09-006, 350012
Study First Received: June 16, 2009
Last Updated: July 18, 2012
Health Authority: Uganda: National Drug Authority

Keywords provided by Cook:
fistula
vesico-vaginal fistula

Additional relevant MeSH terms:
Fistula
Vaginal Fistula
Vesicovaginal Fistula
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Urinary Bladder Fistula
Urinary Fistula
Urogenital Abnormalities
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014