Virtue Male Incontinence Sling Study

Inclusion Criteria:

- Male subject at least 18 yrs old with an estimated life expectancy of more than 5
years

- Confirmed SUI through medical history, uroldynamics, 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: psot-TURP,
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 seriuos bleeding idsorders

- 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

- Subject has previous implant to treat SUI

- Subject has undergone radiation, cryosurgery, or brachy therapy 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