Status:
COMPLETED
A New Therapeutic Strategy for Urethral Sphincter Insufficiency
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Stress Urinary Incontinence
Urethral Intrinsic Sphincter Deficiency
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief 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 therapeuti...
Detailed Description
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 therapeuti...
Eligibility Criteria
Inclusion
- 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
- 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 urinated volume with a micturition \>150cc.
- Dysuria: maximum urinary flow \< 12 ml/sec, IPSS score\>7 or score (men) or MHU dysuria domain none equal to 0 at woman.
- Vesical instability (bladder contraction \> 10 cm H20 during the vesical filling of the cysto-manometry). bladder capacity (B3) \< 300 DC.
- Urethral Stenosis (ureterocystoscopy).
- Previous surgeries for urinary incontinence do not constitute a criterion of exclusion.
- Pregnancy or intention of pregnancy throughout study. A test of pregnancy will be carried out with the visit of inclusion.
- Urethral diverticulum.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00472069
Start Date
April 1 2007
End Date
February 1 2009
Last Update
May 5 2011
Active Locations (1)
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1
Hopital Henri Mondor service Urologie
Créteil, France, 94010