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Sponsored by: |
Coloplast A/S |
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Information provided by: | Coloplast A/S |
ClinicalTrials.gov Identifier: | NCT00856778 |
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 | Phase |
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Stress Urinary Incontinence |
Device: Virtue Male Incontinence Sling |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Virtue Male Incontinence Sling Study |
Estimated Enrollment: | 120 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michele Watrin | 612-302-4975 | usmwa@coloplast.com |
Contact: Joshua Myers, M.S. | 612-287-4170 | usjome@coloplast.com |
United States, California | |
Kaiser Permanente | Recruiting |
Los Angeles, California, United States, 90027 | |
Principal Investigator: Sherif Aboseif, MD | |
Sub-Investigator: Eugene Rhee, MD | |
Stanford University Medical Center | Recruiting |
Stanford, California, United States, 94305 | |
Principal Investigator: Christopher Payne, MD | |
Sub-Investigator: Craig Comiter, MD | |
United States, Florida | |
Winter Park Urology Associates | Recruiting |
Orlando, Florida, United States, 32803 | |
Principal Investigator: Jeffrey Brady, MD | |
United States, Indiana | |
Northeast Indiana Research | Recruiting |
Fort Wayne, Indiana, United States, 46825 | |
Principal Investigator: Christopher Steidle, MD | |
Sub-Investigator: David Pollifrone, MD | |
United States, Michigan | |
Wayne State University | Recruiting |
Dearborn, Michigan, United States, 48124 | |
Principal Investigator: Ajay Singla, MD | |
United States, New York | |
NYU Urology Associates | Recruiting |
New York, New York, United States, 10016 | |
Principal Investigator: Victor W Nitti, MD | |
United States, North Carolina | |
McKay Urology | Recruiting |
Charlotte, North Carolina, United States, 28207 | |
Principal Investigator: Michael Kennelly, MD | |
United States, Texas | |
University of Texas-M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77210 | |
Principal Investigator: Quida Westney, MD | |
Canada, Ontario | |
Sunybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, 4N 3M5 | |
Principal Investigator: Sender Herschorn, MD | |
Canada, Quebec | |
CHUS Hopital Fleurimont | Recruiting |
Sherbrooke, Quebec, Canada, J1H 5N44 | |
Principal Investigator: Le Mai Tu, MD | |
Mortimer S Davis Jewish General Hospital | Recruiting |
Montreal, Quebec, Canada, H3T 1E2 | |
Principal Investigator: Jacques Corcos, MD |
Principal Investigator: | Craig Comiter, MD | Stanford University |
Responsible Party: | Coloplast Corp. ( Michele Watrin, Sr Clinical Program Manager ) |
Study ID Numbers: | CP001SU |
Study First Received: | March 5, 2009 |
Last Updated: | July 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00856778 History of Changes |
Health Authority: | United States: Institutional Review Board; Canada: Health Canada; Netherlands: Dutch Health Care Inspectorate; Italy: Ministry of Health; Denmark: Danish Medicines Agency; Denmark: |
Male sling stress urinary incontinence urinary incontinence |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Signs and Symptoms Urological Manifestations Urinary Incontinence, Stress |
Urologic Diseases Urination Disorders Urinary Incontinence |