Status:
COMPLETED
Virtue® Male Incontinence Sling Study
Lead Sponsor:
Coloplast A/S
Conditions:
Stress Urinary Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
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 produ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00856778
Start Date
January 1 2009
End Date
January 1 2011
Last Update
April 29 2014
Active Locations (11)
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1
Kaiser Permanente
Los Angeles, California, United States, 90027
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
Winter Park Urology Associates
Orlando, Florida, United States, 32803
4
Northeast Indiana Research
Fort Wayne, Indiana, United States, 46825