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 range40 Years – 75 Years
SexALL
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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 …
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