Could a simple vaginal cup help women with fistula leakage?

NCT ID NCT05444504

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for FISTULA are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Gynocare Women's and fistula hospital

    ENROLLING_BY_INVITATION

    Eldoret, Kenya

  • Mercy Women's Catholic Hospital

    RECRUITING

    Mankessim, Ghana

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Tamale Fistula Center

    RECRUITING

    Tamale, Ghana

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact