Virtue Male Incontinence Sling Study - Full Text View

Sponsor:	Coloplast A/S
Information provided by (Responsible Party):	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00856778

Purpose

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.

Condition	Intervention
Stress Urinary Incontinence	Device: Virtue Male Incontinence Sling

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Virtue Male Incontinence Sling Study

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:

Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) and assess change in 24 hour pad weight. [ Time Frame: 12 months post implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess change in subject satisfaction through ICIQ & UCLA-RAND Incont.Index Summarize device & procedure related AEs Assess standardization of surgical protocol and ease of implant via physician questionnaire [ Time Frame: 12 month post implant ] [ Designated as safety issue: Yes ]

Enrollment:	98
Study Start Date:	January 2009
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

The VIRTUE male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.

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 yrs old with an estimated life expectancy of more than 5 years
Confirmed SUI through medical history, uroldynamics, 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: psot-TURP, 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 seriuos bleeding idsorders
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
Subject has previous implant to treat SUI
Subject has undergone radiation, cryosurgery, or brachy therapy 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856778

Locations

United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Winter Park Urology Associates
Orlando, Florida, United States, 32803
United States, Indiana
Northeast Indiana Research
Fort Wayne, Indiana, United States, 46825
United States, Michigan
Wayne State University
Dearborn, Michigan, United States, 48124
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, Texas
University of Texas-M.D. Anderson Cancer Center
Houston, Texas, United States, 77210
Canada, Ontario
Sunybrook Health Sciences Centre
Toronto, Ontario, Canada, 4N 3M5
Canada, Quebec
Mortimer S Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
CHUS Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N44

Sponsors and Collaborators

Coloplast A/S

Investigators

Principal Investigator:

Craig Comiter, MD

Stanford University

More Information

No publications provided

Responsible Party:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT00856778 History of Changes
Other Study ID Numbers:	CP001SU
Study First Received:	March 5, 2009
Last Updated:	March 16, 2012
Health Authority:	United States: Institutional Review Board Canada: Health Canada Netherlands: Dutch Health Care Inspectorate Italy: Ministry of Health Denmark: Danish Medicines Agency Denmark:

Keywords provided by Coloplast A/S:

Male sling
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 May 23, 2012