Umbilical cord tissue may offer new option for bladder leakage surgery
NCT ID NCT06678984
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hôpital Charles-Nicolle, CHU de Rouen
Rouen, 76000, France
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Hôpital Estaing, CHU de Clermont-Ferrand
Clermont-Ferrand, 63100, France
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Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495, France
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Hôpital Michalon, CHU de Grenoble Alpes
La Tronche, 38700, France
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Hôpital Rangueil, CHU de Toulouse
Toulouse, 31400, France
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Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
Paris, 75013, France
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Hôtel-Dieu, CHU de Nantes
Nantes, 44000, France
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Nouvel hôpital civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Magnetic chair therapy aims to strengthen pelvic floor without surgery
- Beyond the pelvis: could hip and leg alignment hold clues to stress incontinence?
- New device aims to stop severe bladder leaks in women
- New device aims to help women with bladder leakage
- Could amniotic membrane make mesh surgery safer for women?
- Which surgery works best for leaky bladder? new study compares top options