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Tiny trial on preventive bladder sling halted early — no clear answers

NCT ID NCT01095692

Prevention Sponsor: Assistance Publique - Hôpitaux de Paris 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 women with pelvic organ prolapse who also had hidden (occult) stress urinary incontinence — leakage that doesn't show up on standard tests. The goal was to see if placing a TOT sling during prolapse surgery could prevent incontinence from appearing later. The trial was terminated early and only 21 women took part, so the results are not strong enough to guide routine care.

What this could mean

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

Active substance
Tension-free vaginal tape (TOT) sling
What this could lead to
If successful, this could show that a preventive sling during prolapse surgery reduces the chance of developing stress incontinence later.
What could go wrong
The trial was terminated early and enrolled only 21 women, so results are very limited. The approach may not work for everyone and carries surgical risks like mesh complications.

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

21 people

The number who actually took part.

Started

Jul 2010

Finished

Oct 2013

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: * Female patients, at least 18 years of age * Having a pelvic organ prolapse and occult stress urinary incontinence * Patient non opposed to the exploitation of data in research * Agree to comply with all protocol-specified procedures, including protocol mandated follow up visits Exclusion Criteria: * Symptoms of stress urinary incontinence preoperatively * Patients not having social security * Pregnancy or lactation

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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

  • Diaconesses Hospital

    Paris, Île-de-France Region, 75012, France

More trials for these conditions

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