Virtue® Male Incontinence Sling Study

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.

Key facts

Study ID

NCT00856778

Run by

Coloplast A/S

People needed

98

Starts

2009-01-01

Expected to finish

2011-01-01

Last updated by the study team

2014-04-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
• Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
• Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
• Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
• Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol
• Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site

You may not qualify if…

• Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
• Subject has active urogenital infection or active skin infection in region of surgery
• Subject has serious bleeding disorders
• Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
• Subject has previous implant to treat SUI
• Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months
• Subject has active urethral or bladder neck stricture disease requiring continued treatment
• Subject has urge predominant incontinence

Where it is running

• Kaiser Permanente — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Winter Park Urology Associates — Orlando, Florida, United States
• Northeast Indiana Research — Fort Wayne, Indiana, United States
• Wayne State University — Dearborn, Michigan, United States
• NYU Urology Associates — New York, New York, United States
• McKay Urology — Charlotte, North Carolina, United States
• University of Texas-M.D. Anderson Cancer Center — Houston, Texas, United States
• Sunybrook Health Sciences Centre — Toronto, Ontario, Canada
• Mortimer S Davis Jewish General Hospital — Montreal, Quebec, Canada
• CHUS Hopital Fleurimont — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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