Virtue® Male Sling Fixation Study

This study has been terminated.
(The study has been terminated due to lack of subject enrollment.)
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01170728
First received: July 26, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Stress Urinary Incontinence
Device: Coloplast Virtue® Male Sling

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtue® Male Sling Fixation Study

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Improvement of incontinence [ Time Frame: 3 months post implant ] [ Designated as safety issue: No ]
  • Safety of the device characterized by reported adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize incontinence severity at various time points [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To evaluate patient quality of life at specified time points [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170728

Locations
United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
Kaiser Permanente
San Diego, California, United States, 92154
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Winter Park Urology
Orlando, Florida, United States, 32803
United States, Georgia
Midtown Urology
Atlanta, Georgia, United States, 30308
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, New York
NYU Urology Associates
New York, New York, United States, 10016
United States, North Carolina
McKay Urology
Charlotte, North Carolina, United States, 28207
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Urology Associates of North Texas
Arlington, Texas, United States, 76017
Sponsors and Collaborators
Coloplast A/S
Investigators
Study Chair: Craig Comiter, MD Stanford University
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01170728     History of Changes
Other Study ID Numbers: CP008SU
Study First Received: July 26, 2010
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Coloplast A/S:
Male Sling
Fixation
Stress Urinary Incontinence
Urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014