Could a simple vaginal cup help women with fistula leakage?

NCT ID NCT05444504

Recruiting now Symptom relief Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This trial tests two insertable vaginal cup devices to help manage urine leakage in women with obstetric fistula, a condition where an opening between the vagina and bladder causes constant leaking. One hundred women who are waiting for surgery or whose surgery failed will try both a basic cup and a cup attached to a leg bag. The study measures how much leakage is reduced and how acceptable the devices are to users.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: insertable vaginal cup device
What this could lead to: If successful, this could offer a non-surgical way to manage fistula-related urine leakage, improving comfort and quality of life for women who cannot have or did not benefit from surgery.
What could go wrong: This is an early-stage trial with only 100 participants, so results may not apply to all women. The devices may not fit everyone or may cause discomfort, and they do not repair the fistula itself.

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Conditions

The condition(s) this trial relates to.

Fistula Urinary Fistula Urinary Incontinence Vaginal Fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FISTULA FISTULA, URINARY FISTULA, VAGINAL OBSTETRIC FISTULA

Contacts and locations

Locations

Gynocare Women's and fistula hospital
ENROLLING_BY_INVITATION

Eldoret, Kenya
Mercy Women's Catholic Hospital
RECRUITING

Mankessim, Ghana
Tamale Fistula Center
RECRUITING

Tamale, Ghana

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