Status:
COMPLETED
I-STOP TOMS - Trans Obturator Male Sling
Lead Sponsor:
CL Medical
Conditions:
Male Urinary Incontinence
Eligibility:
MALE
Phase:
PHASE4
Brief Summary
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 embarrass...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00442078
Start Date
May 1 2006
End Date
June 1 2009
Last Update
September 11 2012
Active Locations (1)
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1
Rouen University Hospital
Rouen, France, 76000