A Phase 3 interventional study of with treated umbilical vein allograft and with autologous fascial pubovaginal sling in Stress Urinary Incontinence in Women, sponsored by TBF Genie Tissulaire. Recruiting at 8 sites in France. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by TBF Genie Tissulaire · Phase 3, Interventional, and Treatment
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:
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 96 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: with treated umbilical vein allograft
Procedure: with autologous fascial pubovaginal sling
Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling
Surgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling
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.
Time frame: 12 months
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.
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.
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital.
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.
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.
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.
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.
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.
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.
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.
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.
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
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."
Time frame: 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.
Time frame: 3 weeks, 3 months, 6 months, 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for May 2028, 29 months after the start.
Of 30 phase 3 interventional studies under Urinary Incontinence, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 29 months is above that.
Start moved once since we started tracking on Sep 25, 2026: Oct 2025 → Nov 2025, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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TBF Genie Tissulaire