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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00352-45 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated umbilical vein allograft | Experimental |
| |
| Autologous Fascial Pubovaginal Sling | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| with treated umbilical vein allograft | Procedure | Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence BARNOUIN, MD | Contact | +33472686909 | laurence.barnouin@tbf-lab.com | |
| Justine BOSC, MSc | Contact | +33472686911 | justine.bosc@tbf-lab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Estaing, CHU de Clermont-Ferrand | Clermont-Ferrand | 63100 | France |
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| with autologous fascial pubovaginal sling | Procedure | Surgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling |
|
The amount of urinary leakage (grams) will be quantified by a one-hour pad test performed during patient visit at the hospital. |
| 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. | 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. | 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. | 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. | 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." | 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. | 3 weeks, 3 months, 6 months, 12 months |
| Hôpital Michalon, CHU de Grenoble Alpes | La Tronche | 38700 | France |
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| Hôtel-Dieu, CHU de Nantes | Nantes | 44000 | France |
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| Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris | Paris | 75013 | France |
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| Hôpital Lyon Sud, Hospices Civils de Lyon | Pierre-Bénite | 69495 | France |
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| Hôpital Charles-Nicolle, CHU de Rouen | Rouen | 76000 | France |
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| Nouvel hôpital civil, Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
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| Hôpital Rangueil, CHU de Toulouse | Toulouse | 31400 | France |
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