Male Urinary Incontinence Clinical Trial
Official title:
Evaluation of the Efficacy on Urinary Continence and Quality of Life of the Sub-urethral Tape I-STOP® Using the Transobturator and Perineal Route on Male Incontinent After Radical Prostatectomy.
The main objective is to evaluate the clinical efficacy on continence, quality of life and tolerance of the sub-urethral tape I-STOP on male patient suffering of incontinence significant and embarrassing after a radical prostatectomy.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 2009 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Male, with post-prostatectomy urinary incontinence (either after radical prostatectomy or prostatectomy of prostate adenoma, whatever the route used), and for whom there has been more than 6 months follow-up since the date of that procedure. - The patient should have been proposed urinary re-education, which was refused for personal reasons, or should still suffer from urinary incontinence despite the re-education. - Urinary incontinence is materialized in this population by a score between 4 and 16 (inclusive) for the three questions of the ICIQ questionnaire. - A urodynamic assessment including flow measurement and residue will have been carried out. - A urethroscopy or urethrography will have been carried out to eliminate cases of urethral stenosis. - Inclusion is subject to obtaining informed written consent, after remittance of the information sheet, and having had a detailed medical examination carried out. - Medication for urinary incontinence and in particular anticholinergic drugs must have been stopped at least 15 days prior to initial assessment and for the duration of the trial. The same goes for urinary re-education. Exclusion Criteria: - Progressing prostatic neoplasia materialized by testing of PSA levels. - Prostate radiotherapy. - Neurological disorder which might lead to urinary incontinence or hinder assessment. - Urethral or anastomotic stenosis materialized by urethroscopy or urethrography. - Hyperactive detrusor muscle with leakage contemporaneous with uninhibited contractility. - Chronic retention of urine with leakage due to overflow. - Current urinary infection. This would be a temporary exclusion since assessment can take place after treatment and monitoring for sterility of urine. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Rouen University Hospital | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| CL Medical |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of continence and QoL with questionnaires and PAD test | 1 month, 3 months, 6 months, 12 months | Yes | |
| Secondary | UCLA SF36 score and ICIQ continence | 1-3-6-12 months | No |