A New Therapeutic Strategy for Urethral Sphincter Insufficiency (NCT00472069) | Clinical Trial Compass
CompletedPhase 1
A New Therapeutic Strategy for Urethral Sphincter Insufficiency
France10 participantsStarted 2007-04
Plain-language summary
Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the urethra. The aim of this procedure is to generate functional tissue acting like a new sphincter in the urethra
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women from 40 to 75 years old, suffering from urinary incontinence since at least 6 months and candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
The myofiber implantation procedure will be proposed after failure of pelvic floor exercises.
* The observation of urine leakage during cough in consultation or during urodynamic (with absence of abnormal vesical contraction) and a score MHU \> 2 (domain of stress urinary incontinence) will be considered as the main diagnostic criteria.
* An urethral closure pressure lower than 40 cm H20 will be the main urodynamic diagnostic criterion
* For women: a negative BONNEY test, and Qtip test\<40° (c.f. annex) demonstrating the absence of vesica-urethral hypermobility.
24 hours Pad test \> 20g.
Exclusion Criteria:
* Incapacity to answer the questionnaires of evaluation.
* History of pelvic radiotherapy.
* Disorder of hemostasis.
* Untreated urinary infection.
* Genetically determined or acquired muscular disease.
* Neurological disorder (Parkinson's disease, multiple sclerosis, spina BIFIDA, medullary traumatism).
* The patients suffering from stress urinary incontinence due to vesica-urethral hypermobility (positive BONNEY test and Qtip test \>40°) will not be included in the study because the referenced treatment is the implantation of a vaginal tape supporting the urethra.
* Incomplete vesical emptying. Residual volume \> 20% of the …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical tolerance and feasibility of a new therapeutic strategy for stress urinary incontinence based on intra urethral myofiber implantation of autologous myofibers with their satellite cells