Virtue Male Incontinence Sling Study
This study has been completed.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00856778
First received: March 5, 2009
Last updated: March 16, 2012
Last verified: March 2012
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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:
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:
-
Device: Virtue Male Incontinence Sling
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 22, 2013