Can we stop fistula repairs from failing? scientists hunt for modifiable risk factors

NCT ID NCT05437939

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study follows women who have had surgery for a female genital fistula, a hole between the bladder and vagina that causes incontinence. The goal is to find factors that can be changed to prevent the repair from breaking down or new incontinence from developing. Researchers will track participants for up to three years and also talk to women to see what kinds of prevention strategies might work in real life.

What this could mean

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

What this could lead to
If successful, this research could identify key targets for interventions that prevent fistula repair failure and incontinence, improving women's health after surgery.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The findings may not apply to all settings or populations.

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.

Participants

802 people

The number who actually took part.

Started

May 2022

Expected to finish

Aug 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.

Who is studied

Up to n=1000 women with successful (closed) vesicovaginal fistula repair who are 18 and older or 15-17 year old emancipated minors (per Ugandan law) will be eligible to participate from fistula surgery centers and hospitals participating in the study as recruitment sites.

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: * Vesicovaginal fistula * Completed surgery with confirmed surgical closure * Age 15 or above, with ages 15-17 meeting criteria for emancipated minor * Capable of providing informed consent Exclusion Criteria: * None beyond above

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Makerere University

    Kampala, Uganda

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