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New surgery aims to fix bladder prolapse without mesh

NCT ID NCT05602246

Disease control Sponsor: Charles University, Czech Republic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new surgical technique called transobturator cystocele repair (TOCR) to the standard anterior repair for fixing a cystocele, a type of pelvic organ prolapse where the bladder bulges into the vagina. About 592 women aged 50 and older with at least stage 2 prolapse will be randomly assigned to one of the two surgeries. The goal is to see which approach is safer and more effective at preventing the prolapse from coming back.

What this could mean

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

Active substance
Transobturator cystocele repair (TOCR) surgery
What this could lead to
If TOCR works better than standard repair, it could offer a more effective, less invasive surgical option for cystocele without using mesh.
What could go wrong
This is a surgical technique trial, not a drug. Success depends on surgeon skill and patient factors. The new method may not prove superior and could carry risks like any surgery.

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 592 people

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

Started

Dec 2022

Expected to finish

Nov 2034

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

50 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: * (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1) * Age ≥ 50 years * Symptom bulge * Ability to speak Czech or English Exclusion Criteria: * Malignancy

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Conditions

The condition(s) this trial relates to.

Cystocele pelvic organ prolapse prolapse of female genital organ

As listed by the trial registrant

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

Cystocele Cystocele and incomplete uterovaginal prolapse Pelvic organ prolapse

How to take part

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

  1. The places running it

    8 sites in 2 countries. 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

  • Faculty of Medicine in Hradec Kralove, Charles University

    NOT_YET_RECRUITING

    Hradec Králové, 500 05, Czechia

  • Faculty of Medicine in Pilsen, Charles University

    RECRUITING

    Pilsen, 30000, Czechia

  • Hospital Pardubice Region, Inc.

    NOT_YET_RECRUITING

    Pardubice, 530 03, Czechia

  • Hospital na Bulovce, 1st Medical Faculty, Charles University

    NOT_YET_RECRUITING

    Prague, 18000, Czechia

  • Košice Medical University

    NOT_YET_RECRUITING

    Košice, 040 11, Slovakia

  • Medical Faculty, Ostrava University

    NOT_YET_RECRUITING

    Ostrava-Poruba, 708 52, Czechia

  • Tomas Bata Regional Hospital in Zlin

    NOT_YET_RECRUITING

    Zlín, 762 75, Czechia

  • Trenčianska univerzita Alexandra Dubčeka

    NOT_YET_RECRUITING

    Trenčín, 911 01, Slovakia

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