Virtue® Male Incontinence Sling Study

Coloplast

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: Virtue® Male Incontinence Sling

Study type

Interventional

Funder types

Industry

Identifiers

NCT00856778

CP001SU

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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