Virtue® Male Sling Fixation Study

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

Study Overview

• Status: Terminated
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Coloplast Virtue® Male Sling

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
  • California
    • San Diego, California, United States, 92154
      • Kaiser Permanente
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Florida
    • Orlando, Florida, United States, 32803
      • Winter Park Urology
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Midtown Urology
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Urology Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • McKay Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Arlington, Texas, United States, 76017
      • Urology Associates of North Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Subjects satisfying inclusion and exclusion criteria were enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Virtue® Male Sling; Device: Coloplast Virtue® Male Sling

Device: Coloplast Virtue® Male Sling; The Virtue Male sling is a class II single use 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). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of incontinence	3 months post implant
Safety of the device characterized by reported adverse events	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To characterize incontinence severity at various time points	24 months
To evaluate patient quality of life at specified time points	24 months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Study Chair: Craig Comiter, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Urinary incontinence; Stress Urinary Incontinence; Fixation; Male Sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: CP008SU