Virtue® Male Incontinence Sling Study

Trial ID or NCT#

NCT00856778

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
View All Criteria
Show Less

Investigator(s)

Craig V. Comiter
Craig V. Comiter
Urologist, Female urologist, Urogynecologist, Pelvic reconstructive surgeon
Professor of Urology and, by courtesy, of Obstetrics and Gynecology

View on ClinicalTrials.gov