Virtue® Male Incontinence Sling Study

Virtue® Male Incontinence Sling Study

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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