Actively Recruiting

Phase Not Applicable
Age: 15Years +
FEMALE
ID05444504

Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial

Led by University of California, San Francisco · Updated on 2025-12-22

100

Participants Needed

3

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

K

Korle-Bu Teaching Hospital, Accra, Ghana

Collaborating Sponsor

AI-Summary

What this Trial Is About

Obstetric fistula causes severe urinary incontinence and stigma, impacting quality of life for many women, particularly in sub-Saharan Africa. This research aims to evaluate two insertable device models for non-surgical management of urinary incontinence in women with obstetric fistula. The study will compare the effectiveness, acceptability, and costs of a vaginal cup alone and a cup connected to a urine collection bag among women awaiting fistula surgery or those with unsuccessful surgery. Participants will experience two intervention models: a vaginal cup inserted to manage leakage and the cup attached by tubing to a leg-secured urine collection bag for increased urine holding capacity. Using a randomized crossover design, 100 women will use each intervention and a no-intervention period for 24 hours each over four days. After this, participants will be re-randomized to use either the cup or cup+ at home for three months to assess long-term acceptability and outcomes. During the study, researchers will measure urine leakage volume, quality of life, stigma, sleep satisfaction, coping, empowerment, safety, and user acceptability using self-reports, clinical checklists, and interviews. Cost assessments will also be performed to understand financial impacts. The study involves multiple assessments over three months, including short-term objective measures and longer-term patient-reported outcomes, to fully evaluate device performance and user experience.

CONDITIONS

Brief Title

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

Who Can Participate

Age: 15Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with vesicovaginal fistula confirmed by dye test and clinical exam at least 3cm from the external urethral orifice
  • Adequate vaginal capacity to accommodate the cup as assessed by a physician
  • Willing to insert and remove the cup or cup+ device
  • Clear understanding of the study procedures
  • Willing to participate fully
  • Not yet repaired or previously had unsuccessful surgical repair and at least 6 months post-surgery
  • If previous fistula repair, at least 3 months post-delivery
  • If recent birth, participant is 18 years or older or an emancipated minor
  • Able to speak English or local language
Not Eligible

You will not qualify if you...

  • Any rectovaginal fistula
  • Urinary leakage less than 6 ml over 6 hours
  • Candidates for catheterization who could heal without surgery (less than 3 months post-delivery)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 4 days

Participants use each of the insertable devices (cup and cup+) and also experience leaking freely for 24 hours each in a randomized crossover design at fistula centers.

Daily visits or assessments during the 4-day crossover period

Implementation

Duration - 3 months

After initial crossover, participants are re-randomized to use either the cup or cup+ device at home for ongoing management of fistula-related urinary incontinence.

Periodic visits or assessments during the 3-month home use period

Trial Site Locations

Total: 3 locations

1

Mercy Women's Catholic Hospital

Mankessim, Ghana

Actively Recruiting

2

Tamale Fistula Center

Tamale, Ghana

Actively Recruiting

3

Gynocare Women's and fistula hospital

Eldoret, Kenya

Enrolling by Invitation

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Research Team

N

Nessa E Ryan, PhD

A

Alison M El Ayadi, ScD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

"I am alone and isolated": a qualitative study of experiences of women living with genital fistula in Uganda.

Justus Kafunjo Barageine, Jolly Beyeza-Kashesya, Josaphat K Byamugisha...

https://pubmed.ncbi.nlm.nih.gov/26359255

Current evidence supporting obstetric fistula prevention strategies in sub Saharan Africa: a systematic review of the literature.

Aduragbemi O Banke-Thomas, Oluwasola E Wilton-Waddell, Salam F Kouraogo...

https://pubmed.ncbi.nlm.nih.gov/25438516