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Umbilical cord tissue may offer new option for bladder leakage surgery

NCT ID NCT06678984

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a treated umbilical vein graft can effectively treat stress urinary incontinence in women, comparing it to the standard sling made from the patient's own tissue. About 96 women will receive one of the two surgical treatments and be followed for a year. The main goal is to see if the donated graft reduces urine leakage as well as the standard approach.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 96 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

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: * Women aged 18 to 85 years. * Patients with stress urinary incontinence or mixed urinary incontinence with a predominant stress component. * Patients with stress urinary incontinence due to cervico-urethral hypermobility or urethral hypermobility. * Patients with urethral hypermobility confirmed by Ulmsten suburethral support maneuver. * Urinary incontinence demonstrated by one-hour pad test. * Patients with significant and persistent discomfort despite perineal rehabilitation. * Patients able to understand the information concerning the study and having voluntarily dated and signed the informed consent form. * Patients able and willing to comply with the requirements and instructions of the study. * Patients who are members or the beneficiary of a national health insurance plan. Exclusion Criteria: * Pregnant or breastfeeding women or those not using effective contraception. * Patients with a body mass index (BMI) ≥ 35 kg/m2. * Patients with moderate stress urinary incontinence treated with physiotherapy and pelvic support exercises. * Patients with voiding disorders or at risk of performing self-catheterization. * Patients who have already undergone surgical treatment for urinary incontinence. * Patients unable to perform the pad test or unwilling to perform it at each follow-up visit. * Patients considered by the principal investigator to be poor candidates for surgical procedures and/or anesthesia due to their physical or mental state. * Patients with current urinary tract infection, severe anemia, uncontrolled diabetes or other conditions contraindicating surgery. * Patients with neurogenic bladder. * Patients with a history of conditions, illnesses or surgical procedures that may confound the results of the urinary incontinence assessment, including but not limited to: pelvic organ prolapse (e.g., cystocele, rectocele), neurological disorders (e.g., multiple sclerosis, Parkinson's disease), recurrent urinary tract infections, recurrent bladder stones, interstitial cystitis, history of pelvic irradiation (external beam therapy or brachytherapy), current diagnosis of genitourinary malignancy. * Patients deprived of liberty by a judicial or administrative decision. * Patients incapable of discernment for rehabilitation, unable to follow up or give consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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. 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

  • Hôpital Charles-Nicolle, CHU de Rouen

    Rouen, 76000, France

  • Hôpital Estaing, CHU de Clermont-Ferrand

    Clermont-Ferrand, 63100, France

  • Hôpital Lyon Sud, Hospices Civils de Lyon

    Pierre-Bénite, 69495, France

  • Hôpital Michalon, CHU de Grenoble Alpes

    La Tronche, 38700, France

  • Hôpital Rangueil, CHU de Toulouse

    Toulouse, 31400, France

  • Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris

    Paris, 75013, France

  • Hôtel-Dieu, CHU de Nantes

    Nantes, 44000, France

  • Nouvel hôpital civil, Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

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