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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00442078 |
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Date of registration:
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27/02/2007 |
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Primary sponsor: |
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Public title:
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I-STOP TOMS - Trans Obturator Male Sling
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Scientific title:
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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. |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00442078 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe GRISE, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rouen University Hospital - France |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Male Urinary Incontinence
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Intervention(s)
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Device: I-STOP TOMS male sling
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Primary Outcome(s)
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Evaluation of continence and QoL with questionnaires and PAD test
[Time Frame: 1 month, 3 months, 6 months, 12 months]
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Secondary Outcome(s)
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UCLA SF36 score and ICIQ continence
[Time Frame: 1-3-6-12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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