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New custom pessary aims to solve fit problems for pelvic organ prolapse

NCT ID NCT06954701

Symptom relief Sponsor: University of Alberta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new pessary that is custom-shaped to each woman's body for treating pelvic organ prolapse (POP). About 43 women who already use a standard pessary will try the new device for 3 months. The goal is to see if the custom fit improves comfort, ease of use, and symptom relief compared to traditional one-size-fits-all pessaries.

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 43 people

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

Started

Apr 2026

Expected to finish

Oct 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

18 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: * Patients assigned female at birth * At least 18 years old at time of screening * Patients with symptomatic POP using a pessary for ≥ 3 months * Capable of giving informed consent * Fluency in English Exclusion Criteria: * Pregnancy * Short vaginal length (total vaginal length \<5 cm) or subjective vaginal narrowing * Vaginal erosion due to current pessary * Presence of vesicovaginal fistula * Presence of rectovaginal fistula * Current treatment for vaginal, rectal, or bladder tumor * Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary * Presence of pelvic, vaginal, or urinary infection requiring treatment * Ongoing treatment of recurrent urinary tract or vaginal infections * Inflammatory bowel disease * Chronic pain syndromes of pelvic or anorectal origin * Previous pelvic floor surgery in last 12 months * Congenital malformation of bladder, rectum, or vagina * Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, ambulatory restrictions, etc.) * Planning pregnancy in next 6 months

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse

As listed by the trial registrant

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

Pelvic organ prolapse (POP)

How to take part

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

  1. The places running it

    1 site. 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

  • Dale Sheard Centre for Solutions in Women's Health

    RECRUITING

    Edmonton, Alberta, T5H3V9, Canada

More trials for these conditions

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