©2024 Stanford Medicine
Virtue® Male Incontinence Sling Study
Not Recruiting
Trial ID: NCT00856778
Purpose
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.
Official Title
Virtue® Male Incontinence Sling Study
Stanford Investigator(s)
Craig V. Comiter
Professor of Urology and, by courtesy, of Obstetrics and Gynecology
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
Intervention(s):
device: Virtue® Male Incontinence Sling
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305