Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence

Jewish General Hospital1 site in 1 country128 target enrollmentJune 2012

ConditionsStress Urinary Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stress Urinary Incontinence
Sponsor: Jewish General Hospital
Enrollment: 128
Locations: 1
Primary Endpoint: Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight .
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

June 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Jewish General Hospital

Responsible Party

Principal Investigator

Jacques Corcos

MD. Professor of Urology, McGill University

Jewish General Hospital

Eligibility Criteria

Inclusion Criteria

•The subject is male
•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

Exclusion Criteria

•Subjects who meet any of the following criteria are excluded from entry into the study
•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