Virtue® Male Incontinence Sling Study
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: Virtue® Male Incontinence Sling
- Registration Number
- NCT00856778
- Lead Sponsor
- Coloplast A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 98
- Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
- Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, 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: post-TURP (trans-urethral resection of the prostate), 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
- 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 serious bleeding disorders
- Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
- Subject has previous implant to treat SUI
- Subject has undergone radiation, cryosurgery, or brachytherapy 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Virtue® Male Sling Virtue® Male Incontinence Sling Subjects implanted with Virtue® Male Sling
- Primary Outcome Measures
Name Time Method Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) 12 months post implant Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: \>50% responding "very much better" or "much better".
Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry). 12 months Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = \<12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: \>50% responding "very much better" or "much better".
- Secondary Outcome Measures
Name Time Method Assess Change in Subject Satisfaction Through ICIQ 12 months post implant The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother 12 months post implant The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function 12 months post implant The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Assess Change in Pad Use 12 months post-implant Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward At implant Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies At implant Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra At implant
Trial Locations
- Locations (11)
Stanford University Medical Center
🇺🇸Stanford, California, United States
Mortimer S Davis Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Northeast Indiana Research
🇺🇸Fort Wayne, Indiana, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
NYU Urology Associates
🇺🇸New York, New York, United States
Wayne State University
🇺🇸Dearborn, Michigan, United States
Sunybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Winter Park Urology Associates
🇺🇸Orlando, Florida, United States
McKay Urology
🇺🇸Charlotte, North Carolina, United States
University of Texas-M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
CHUS Hopital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada