Stress Urinary Incontinence in WomenPhase 3NCT06678984
Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascial Pubovaginal Sling in the Treatment of Female Stress Urinary Incontinence
A Phase 3 study testing with treated umbilical vein allograft and with autologous fascial pubovaginal sling in people with Stress Urinary Incontinence in Women, run by TBF Genie Tissulaire at 8 sites in France.
Trial summary
The goal of this clinical trial is to evaluate whether a treated umbilical vein allograft is effective in treating stress urinary incontinence in females. The researchers will compare the treated umbilical vein allograft with a sling made of autologous tissue. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Stress Urinary Incontinence in Women
- What is being tested?
- with treated umbilical vein allograft and with autologous fascial pubovaginal sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 8 sitesFrance
- Study dates
- 6 Nov 2025to 1 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Hôpital Estaing, CHU de Clermont-Ferrand
Clermont-Ferrand, 63100
Sandrine Campagne-Loiseau, MD
- Recruiting
Hôpital Michalon, CHU de Grenoble Alpes
La Tronche, 38700
Caroline THUILLIER, MD
- Recruiting
Hôtel-Dieu, CHU de Nantes
Nantes, 44000
Marie-Aimée PERROUIN-VERBE, Professor
Marie-Liesse DE GUERRY DE BEAUREGARD, MD
- Recruiting
Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris
Paris, 75013
Kamilia ZEDEK, 184828323 ext. +33, kamilia.zedek@aphp.fr
Emmanuel CHARTIER-KASTLER, Professor
- Recruiting
Hôpital Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
Alain RUFFION, Professor
Théo ARBER, MD
- Recruiting
Hôpital Charles-Nicolle, CHU de Rouen
Rouen, 76000
Jean-Nicolas CORNU, Professor
- Recruiting
Nouvel hôpital civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Christian SAUSSINE, Professor
Baptiste POUSSOT, MD
- Recruiting
Hôpital Rangueil, CHU de Toulouse
Toulouse, 31400
Xavier GAME, Professor
About this study
The goal of this clinical trial is to evaluate whether a treated umbilical vein allograft is effective in treating stress urinary incontinence in females. The researchers will compare the treated umbilical vein allograft with a sling made of autologous tissue. The main question the clinical trial aims to answer is:
- Is the treated umbilical vein allograft as effective as the sling made of autologous tissue for treating female stress urinary incontinence?
Read more
Participants will:
- Undergo surgical treatment with either the umbilical vein allograft or the sling made of autologous tissue on Day 0.
- Visit the hospital for a series of tests at 3 weeks, 3 months, 6 months, and 12 months after the surgical intervention.
- Record their bladder activity between each hospital visit.
Read the detailed description
It is estimated that more than 9 million French people are affected by urinary incontinence, of which 1% are treated surgically. When medical management or rehabilitation fails, surgical treatment must be considered. Sling implantation is a commonly used surgical technique for treating stress urinary incontinence, as it reduces surgery time and morbidity, and can be performed under local anesthesia. However, the risk of complications associated with the use of synthetic materials is significant, contributing to a recent decline in the popularity of synthetic slings.
Given the high demand for incontinence treatments, autologous fascia sling surgeries are being proposed, despite requiring an additional surgical procedure and exposing patients to complications at the donor site of the graft.
The study product aims to address the need for a safer, equally effective implant that eliminates the need for autografting while maintaining standard surgical techniques.
The aim of this comparative study is to determine whether the efficacy of the treated umbilical vein allograft can justify its use as a substitute for the autologous fascial sling, thereby avoiding the complications associated with harvesting the autograft.
- Conditions
- Stress Urinary Incontinence in Women
- Being tested
- with treated umbilical vein allograft, with autologous fascial pubovaginal sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with treated umbilical vein allograftProcedure or surgery
Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling
with autologous fascial pubovaginal slingProcedure or surgery
Surgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling
| Study group | Role | What they receive |
|---|---|---|
| Treated umbilical vein allograft | Experimental | Not described Receives: Procedure: with treated umbilical vein allograft |
| Autologous Fascial Pubovaginal Sling | Active comparator | Not described Receives: Procedure: with autologous fascial pubovaginal sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatment groups in change from baseline to final 12-month postoperative visits in the amount of urinary leakage.
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital.
One-hour pad test will be performed in the following way:
- Subject puts on one standardized, pre-weighed pad without voiding.
- 0-15 Minutes: Subject drinks 500 mL of sodium-free liquid in < 15 min while sitting or resting.
- 15 - 45 Minutes: Subject walks for 30 minutes, including climbing one flight of stairs (up and down).
- 45 - 60 Minutes: Subject performs the following activities: Standing up from sitting (10 times), Coughing vigorously (10 times), Running on the spot (1 min), Bending to pick up an object from the floor (5 times), Wash hands in running water (1 min).
- The weight of the pad is measured to determine the amount of leakage.
Measured: 12 months
Secondary outcomes (8)
Difference between treatment groups in change from baseline to 3- and 6-month postoperative visits in the amount of urinary leakage.
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visits at the hospital.
Measured: 3 months, 6 months
Difference between treatment groups in the proportion of subjects who achieved a reduction of more than 50% in the amount of urinary leakage between baseline and the 12-month visit.
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital.
Measured: 12 months
Difference between treatment groups in change from baseline to final 12-month postoperative visits in the number of incontinence episodes and pads used daily.
The number of incontinence episodes and pads used daily will be determined from a voiding calendar carried out by the patient at home over a 3-day period.
Measured: 12 months
Difference between treatment groups in changes between initial and postoperative visits in frequency, severity and impact on quality of life of patients' urinary incontinence, as measured by the ICIQ-UI-SF.
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.
Measured: 3 months, 6 months, 12 months
Difference between treatment groups in changes between initial and postoperative visits in the distress caused by urinary incontinence symptoms, as measured by the UDI-6.
The Urogenital Distress Inventory (UDI-6) assess the distress caused by urinary incontinence symptoms. The UDI-6 total score ranges from 0 to 100, with higher scores indicating more distressing symptoms.
Measured: 3 months, 6 months, 12 months
Difference between treatment groups in changes between initial and postoperative visits in the psychosocial impact of urinary incontinence in patients, as measured by the IIQ-7.
The Incontinence Impact Questionnaire (IIQ-7) assess the psychosocial impact of urinary incontinence in female patients. The IIQ-7 total score ranges from 0 to 100, with higher scores indicating a greater psychosocial impact of urinary incontinence on the patient.
Measured: 3 months, 6 months, 12 months
Difference between treatment groups in changes between initial and postoperative visits in the patients' perceived symptom improvement, as measured by the PGI-I
Patients' perceived improvement in urinary incontinence symptoms will be assessed with the Patient Global Impression of Improvement (PGI-I). PGI-I measures improvement on a scale of 1 "very much better" to 7 "very much worse."
Measured: 3 months, 6 months, 12 months
Difference between treatment groups in rates of specific complications
Rate of specific complications, including skin reaction, delayed healing, urinary retention, injury to the bladder or other abdominal structures, severe and persistent pain will be evaluated during each patient's post-operative visits to the hospital.
Measured: 3 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start6 Nov 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence in WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678984
- Sponsor's protocol ID
- UVT-TBF2
- Other IDs
- 2024-A00352-45
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascial Pubovaginal Sling in the Treatment of Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06678984
- Acronym / sponsor ID
- UVT-TBF2
- Conditions
- Stress Urinary Incontinence in Women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether a treated umbilical vein allograft is effective in treating stress urinary incontinence in females. The researchers will compare the treated umbilical vein allograft with a sling made of autologous tissue. The main question the clinical trial aims to answer is:
- Is the treated umbilical vein allograft as effective as the sling made of autologous tissue for treating female stress urinary incontinence?
Participants will:
- Undergo surgical treatment with either the umbilical vein allograft or the sling made of autologous tissue on Day 0.
- Visit the hospital for a series of tests at 3 weeks, 3 months, 6 months, and 12 months after the surgical intervention.
- Record their bladder activity between each hospital visit.
Detailed description
It is estimated that more than 9 million French people are affected by urinary incontinence, of which 1% are treated surgically. When medical management or rehabilitation fails, surgical treatment must be considered. Sling implantation is a commonly used surgical technique for treating stress urinary incontinence, as it reduces surgery time and morbidity, and can be performed under local anesthesia. However, the risk of complications associated with the use of synthetic materials is significant, contributing to a recent decline in the popularity of synthetic slings.
Given the high demand for incontinence treatments, autologous fascia sling surgeries are being proposed, despite requiring an additional surgical procedure and exposing patients to complications at the donor site of the graft.
The study product aims to address the need for a safer, equally effective implant that eliminates the need for autografting while maintaining standard surgical techniques.
The aim of this comparative study is to determine whether the efficacy of the treated umbilical vein allograft can justify its use as a substitute for the autologous fascial sling, thereby avoiding the complications associated with harvesting the autograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated umbilical vein allograft | Experimental | Procedure: with treated umbilical vein allograft |
| Autologous Fascial Pubovaginal Sling | Active comparator | Procedure: with autologous fascial pubovaginal sling |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with treated umbilical vein allograftSurgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling | Procedure or surgery | Treated umbilical vein allograft |
| with autologous fascial pubovaginal slingSurgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling | Procedure or surgery | Autologous Fascial Pubovaginal Sling |
Primary outcome
Difference between treatment groups in change from baseline to final 12-month postoperative visits in the amount of urinary leakage.
Time frame: 12 months
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital. One-hour pad test will be performed in the following way: * Subject puts on one standardized, pre-weighed pad without voiding. * 0-15 Minutes: Subject drinks 500 mL of sodium-free liquid in < 15 min while sitting or resting. * 15 - 45 Minutes: Subject walks for 30 minutes, including climbing one flight of stairs (up and down). * 45 - 60 Minutes: Subject performs the following activities: Standing up from sitting (10 times), Coughing vigorously (10 times), Running on the spot (1 min), Bending to pick up an object from the floor (5 times), Wash hands in running water (1 min). * The weight of the pad is measured to determine the amount of leakage.
8 secondary outcomes
Difference between treatment groups in change from baseline to 3- and 6-month postoperative visits in the amount of urinary leakage.
Time frame: 3 months, 6 months
Difference between treatment groups in the proportion of subjects who achieved a reduction of more than 50% in the amount of urinary leakage between baseline and the 12-month visit.
Time frame: 12 months
Difference between treatment groups in change from baseline to final 12-month postoperative visits in the number of incontinence episodes and pads used daily.
Time frame: 12 months
Difference between treatment groups in changes between initial and postoperative visits in frequency, severity and impact on quality of life of patients' urinary incontinence, as measured by the ICIQ-UI-SF.
Time frame: 3 months, 6 months, 12 months
Difference between treatment groups in changes between initial and postoperative visits in the distress caused by urinary incontinence symptoms, as measured by the UDI-6.
Time frame: 3 months, 6 months, 12 months
Difference between treatment groups in changes between initial and postoperative visits in the psychosocial impact of urinary incontinence in patients, as measured by the IIQ-7.
Time frame: 3 months, 6 months, 12 months
Difference between treatment groups in changes between initial and postoperative visits in the patients' perceived symptom improvement, as measured by the PGI-I
Time frame: 3 months, 6 months, 12 months
Difference between treatment groups in rates of specific complications
Time frame: 3 weeks, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing with treated umbilical vein allograft and with autologous fascial pubovaginal sling in people with Stress Urinary Incontinence in Women, run by TBF Genie Tissulaire at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence BARNOUIN, MD (+33472686909, laurence.barnouin@tbf-lab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between treatment groups in change from baseline to final 12-month postoperative visits in the amount of urinary leakage. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.