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Could a simple vaginal cup help women with fistula leakage?

NCT ID NCT05444504

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician) * Willing to insert and remove cup/cup+ * Clear understanding of the study procedures * Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery * If previous fistula repair, ≥3mo post-delivery * If recent birth, age 18+ or emancipated minor * Speak English or local language Exclusion criteria: * Any rectovaginal fistula * Urinary leakage \<6ml over 6 hours * Women who are candidates for catheterization who could be healed without surgery will be excluded as they are \<3mo post-delivery.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

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