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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00472069 |
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
Condition | Intervention | Phase |
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Stress Urinary Incontinence Striated Urethral Sphincter Insuffisciency |
Procedure: transplantation of the squeletic muscular cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | EVALUATION Of A NEW THERAPEUTIC STRATEGY FOR URETHRAL SPHINCTER INSUFFICIENCY BASED ON THE INTRA-URETHRAL IMPLANTATION OF AUTOLOGOUS MYOFIBERS WITH THEIR SATELLITE CELLS |
Estimated Enrollment: | 10 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
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A: Experimental | Procedure: transplantation of the squeletic muscular cells |
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.
The principle of this procedure relies on the activation in vivo of the satellite cells present around each myofibers. Satellite cell activation is concomitant with myofiber death that occurs after their implantation. Activated satellite proliferate and fuse to form myotubes replacing the parental myofibers thus leading to the reconstitution of the muscle mass that was initially implanted. Preliminary studies in the pig showed the regenerated muscle tissue in the urethra was innervated by urethral nerves and developed tonic contractions acting like a new sphincter. This procedure does not include a phase of satellite cell amplification ex vivo, as standard methods of satellite cell transfer, and rather relies on the natural myogenic capacities of these cells. Thus, the procedure of cell transfer into the urethra is considerably simplified and can be performed in one step in the operating room.This therapeutic strategy could represent an alternative to the artificial urinary sphincter.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The myofiber implantation procedure will be proposed after failure of pelvic floor exercises.
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:
Contact: René YIOU, MD,PhD | +33(0)1 49 81 25 53 | rene.yiou@hmn.aphp.fr |
France | |
Hopital Henri Mondor service Urologie | Recruiting |
CRETEIL, France, 94010 | |
Contact: René YIOU, MD,PhD +33(0) 1 49 81 25 53 rene.yiou@hmn.aphp.fr |
Principal Investigator: | René YIOU, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P060505 |
Study First Received: | May 10, 2007 |
Last Updated: | September 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00472069 History of Changes |
Health Authority: | France: Ministry of Health |
Stress Urinary Incontinence striated urethral sphincter insufficiency myofibers satellite cells |
myotubes urethral Muscle fibres |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Signs and Symptoms Urological Manifestations Urinary Incontinence, Stress |
Urologic Diseases Urination Disorders Urinary Incontinence |