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The pessary puzzle: why half of women quit within a year

NCT ID NCT06021769

Knowledge-focused Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Pessaries are silicone devices inserted into the vagina to treat pelvic organ prolapse and stress urinary incontinence. Many women stop using them within a year. Researchers at the University of Virginia are following 30 women who start using a pessary to understand what makes them continue or quit. The study uses questionnaires and interviews to track symptoms, quality of life, and reasons for stopping.

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 researchers learn why women stop using pessaries, doctors could offer better support and adjustments, helping more women keep using a device that eases pelvic floor symptoms.
What could go wrong
This is a small observational study of 30 women at one clinic, so its findings may not apply to everyone. It will not test whether pessaries work, only why some women stop using them.

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

About 30 people

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

Started

Jun 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.

Who is studied

Women in the area surrounding the University of Virginia who have stress urinary incontinences or pelvic organ prolapse.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * English-speaking women aged 18 years or older * Choosing to undergo a pessary fitting for symptomatic pelvic organ prolapse and/or stress urinary incontinence at the University of Virginia Pelvic Medicine and Reconstructive Surgery clinic * Willingness and ability to comply with scheduled visits and study procedures. * Successful pessary fitting Exclusion Criteria: * Pregnant women * Prisoners * Cognitively impaired * Non-English speaking subjects * Patients who cannot comply with pessary check visits * Active vaginal infection * Vaginal malignancy * Genitourinary tract fistula

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Conditions

The condition(s) this trial relates to.

female stress incontinence pelvic organ prolapse Urinary Incontinence, Stress

As listed by the trial registrant

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

Pelvic organ prolapse Stress urinary incontinence

Contacts and locations

Locations

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

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