Virtue® Male Sling Fixation Study

Terminated

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Coloplast Virtue® Male Sling

• Registration Number: NCT01170728
• Lead Sponsor: Coloplast A/S

Brief Summary

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

• Male subject at least 18 years of age with an estimated life expectancy of 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 completed post-void residual per protocol within 6 weeks prior to implant
• The subject has completed cystoscopy as per protocol within 12 months prior to implant
• The subject has intrinsic sphincter deficiency due to one of the following: post-transurethral resection of the prostate (TURP), simple open prostatectomy, or radical prostatectomy completed at least 6 months prior to implantation date
• The subject has failed at least two non-invasive therapies, eg. pelvic/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 the protocol
• The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics committee of the respective site

Exclusion Criteria

• The subject is unable or unwilling to sign the informed consent form (ICF)and/or 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
• The subject has serious bleeding disorders
• The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, cerebrovascular accident (CVA), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar condition
• The subject had a previous implant to treat stress urinary incontinence
• 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 6 months
• The subject has active urethral or bladder neck stricture disease requiring continued treatment
• The subject has urge predominant incontinence
• The subject has an atonic bladder or a postvoid residual (PVR) greater than or equal to 150 milliliters (mL)
• The subject has a condition or disorder likely to require future transurethral procedure
• The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without sponsor's approval
• The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by attending physician

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Virtue® Male Sling	Coloplast Virtue® Male Sling	Device: Coloplast Virtue® Male Sling

Primary Outcome Measures

Name	Time	Method
Improvement of incontinence	3 months post implant
Safety of the device characterized by reported adverse events	3 months

Secondary Outcome Measures

Name	Time	Method
To characterize incontinence severity at various time points	24 months
To evaluate patient quality of life at specified time points	24 months

Trial Locations

Locations (10)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Winter Park Urology; 🇺🇸 Orlando, Florida, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

NYU Urology Associates; 🇺🇸 New York, New York, United States

Kaiser Permanente; 🇺🇸 San Diego, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

McKay Urology; 🇺🇸 Charlotte, North Carolina, United States

Midtown Urology; 🇺🇸 Atlanta, Georgia, United States

Urology Associates of North Texas; 🇺🇸 Arlington, Texas, United States