AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence
NCT ID: NCT01866085
Last Updated: 2013-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
128 participants
INTERVENTIONAL
2012-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AdVance
sling procedure
AdVance® sling procedure
ARGUS
sling procedure
ARGUS Sling procedure
Interventions
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AdVance® sling procedure
ARGUS Sling procedure
Eligibility Criteria
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Inclusion Criteria
* The subject is at least 18 years of age
* The subject has an estimated life expectancy of more than 5 years
* The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
* The subject has intrinsic sphincter deficiency due to one of the following:
post-TURP, simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
* Positive Cough Stress Test (CST):
* Positive 24-hours Pad Test (PT):
A positive PT is confirmed with leakage of \>8.O g/24h and \< 400 g
* The subject has completed urodynamics, uroflow, post-void residual, and cystoscopy as per the protocol within 6 months prior to implant
* The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol
* The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics commit-tee of the respective site
Exclusion Criteria
* The subject is unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements according to the study protocol
* The subject has an active urogenital infection or active skin infection in region of surgery
* The subject has serious bleeding disorders
* The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
* The subject had a previous implant to treat stress urinary incontinence
* The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
* The subject is likely to undergo radiation therapy within the next 6 months
* The subject has active urethral or bladder neck stricture disease, requiring continued treatment
* The subject has urge predominant incontinence
* The subject has an atonic bladder or a postvoid residual (PVR) ≥150mL
* The subject has a condition or disorder likely to require future transurethral procedure
* The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsors'approval
* Subjects who in the opinion of the investigator are unable and/or unlikely to to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
18 Years
MALE
No
Sponsors
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Center Hospitalier de Fleurimont,Sherbrooke University
UNKNOWN
Sunnybrook Health Sciences Centre
OTHER
Jewish General Hospital
OTHER
Responsible Party
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Jacques Corcos
MD. Professor of Urology, McGill University
Locations
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Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Jacques Corcos, MD
Role: primary
Role: backup
Other Identifiers
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12-013
Identifier Type: OTHER
Identifier Source: secondary_id
12-013
Identifier Type: -
Identifier Source: org_study_id