Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00472069
Eligibility Criteria:
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00472069
Study Brief:
Protocol Section:
NCT00472069