Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Coloplast A/S

Stanford Investigator(s):

Intervention(s):

  • Device: Virtue┬« Male Incontinence Sling

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting