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 (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