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Can a simple cup stop the leak? new study tests menstrual cup for fistula

NCT ID NCT03414060

Disease control Sponsor: University of Ghana Medical School Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looked at whether a menstrual cup can help women with vesicovaginal fistula (VVF) manage urine leakage while waiting for surgery. Eleven women in Ghana tested the cup, and researchers measured how much urine leaked with and without it. They also asked about comfort and ease of use. The goal was to see if the cup is a practical short-term option to reduce stigma and improve daily life.

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

11 people

The number who actually took part.

Started

Aug 2016

Finished

Dec 2016

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: 1. Patient seeking surgical repair for VVF 2. VVF confirmed by gynecologic examination 3. Adequate vaginal capacity to accommodate the menstrual cup 4. Fistula high in vagina (determined at gynecologic examination) 5. Willingness to insert and remove the device by one's self Exclusion Criteria: 1. Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina) 2. Unable or unwilling to learn to insert and remove the menstrual cup 3. Patient who declines consent or is incapable of consent 4. Presence of rectovaginal fistula (RVF) or combined RVF and VVF 5. Fistula low in the vagina precluding collection of urine by the menstrual cup

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Conditions

The condition(s) this trial relates to.

injury Vaginal Fistula Vesicovaginal Fistula

As listed by the trial registrant

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

Obstetric; injury Vaginal fistula Vesico vaginal fistula

Contacts and locations

Locations

  • Mercy Women's Catholic Hospital

    Mankessim, Central Region, Ghana

More trials for these conditions

Other studies related to the condition(s) this trial covers.