Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatment virtue® male sling
Phase phase 4
Sponsor Coloplast A/S
Start date August 2012
End date February 2016
Trial size 123 participants
Trial identifier NCT01608789, SU012

Summary

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
virtue® male sling
The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD).

Primary Outcomes

Measure
Improvement of urinary incontinence based on 24-hour pad test
time frame: 1 year
Safety of the device characterized by reported adverse events
time frame: 1 year

Secondary Outcomes

Measure
Improvement of urinary incontinence based on 24-hour pad test
time frame: Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
Improvement of urinary incontinence based on number of pad used
time frame: baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
Subject reported improvement measured by the PGI-I
time frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form
time frame: baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
Patient satisfaction questionaire
time frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Safety of the device characterized by reported adverse events
time frame: Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - The subject has an estimated life expectancy of more than 5 years - The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months - The subject has intrinsic sphincter deficiency due to radical prostatectomy completed at least 1 year prior to implantation date - The subject has a good bladder function - The subject has failed non-invasive therapies, eg. Pelvic Floor/Kegel exercises, behavioral modification, or biofeedback, for at least 6 months - The subject is willing to have the Virtue® Male Sling implanted - The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol Exclusion Criteria: - The subject is unable or unwilling to comply with all follow-up requirements according to the study protocol - The subject has an active urinary tract infection or active skin infection in region of surgery (temporary exclusion) - The subject has compromised immune systems or any other conditions that affect healing - The subject has serious bleeding disorders - The subject has an urinary incontinence that is not mainly a stress urinary incontinence - The subject has a stress urinary incontinence due to TransUrethral Resection or laser surgery of the Prostate (TURP) - The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions - The subject had a previous implant (male sling, Artificial Urinary Sphincter) to treat stress urinary incontinence (previous implanted bulking agents are allowed) - The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months - The subject is likely to undergo radiation therapy within the next 3 months - The subject has a postvoid residual (PVR) > or = 150mL - The subject has recently required transurethral instrumentation for urethral or urethro-vesical anatomosis stricture within the previous 6 months - The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without the sponsors' approval - The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by the attending physician

Additional Information

Official title Virtue® Male Sling European Study
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Coloplast A/S.