Stress urinary incontinence or unvoluntary loss of urine
Conditions
Interventions
Surgical procedure: implantation of the Virtue male sling and creating tension
to support the bulbous urethra with the aid of the two prepubic arms and 2
transobturator arms of the sling. The surgic
Sponsors
Coloplast BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *the subject is male *the suject is at least 18 years of age *the subject has an estimated life expectancy of more than 5 years *the subject has confirmed stress urinary incontinence (SUI) throug medical history, urodynamics and/or pysical exam for at least 6 months * the subject has intrinsic sphincter deficiency due to radical prostatectomy completed at least 1 year prior to implantation date *the subject has a good bladder function *the subject has failed non-invasive therapies eg. Pelvic Floor/Kegel exercises, behavioral modification or biofeedback for at least 6 months *the subject is willing to have the Virtue male sling implanted *the subject is able and willing to complete all follow-up visits and procedures indicated in this protocol.
Exclusion criteria
Exclusion criteria: *the subject is unable or unwilling to comply with all follow-up requirements according to the study protocol *the subject has an active urinary tract infection or active skin infection in region of surgery *the subject has compromised immune systems or any other conditions affect healing *the subject has serious bleeding disorders *the subject has an urinary incontinence that is not mainly a stress urinary incontinence * the subject has a stress urinary incontinence due to TransUrethralResection or laser surgery of the prostate (TURP) *the 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. *the subject had a previous implant (male sling, Artificial Urinary Sphincter) to treat stress urinary incontinence (previous implanted bulking agensts are allowed) *the subject has undergone radiation, cryosurgery or brachy therapy to treat prostate- or pelvic cancer within 6 months. *the subject is likely to undergo radiation therapy within the next 3 months *the subject has a postvoid residual (PVR) equal to or more than 150 ml *the subject has recently required transurethral instrumentation for urethral or urethro-vesical anatomosis stricture within the previous 6 months. * the subject is enrolled in a concurrent clinical study of any treatment (drug or devise) that could affect continence function without the sponsors'approval. * the subject is deemed unfit for male sling implantation or participation in a research protocol as determined by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of this study is to assess the efficacy and safety of the surgical procedure based on improvement in 24-hour pad weight and adverse event reporting in the Virtue® Male Sling European Study at 12 months post implant. Secondary objectives will assess subject satisfaction, patient reported pad use, and change in 24 hour pad weight through 36 months. The primary end point will be based on the following endpoints after the 12 months follow-up is complete: *Efficacy: The primary effectiveness end point will be improvement in pad weight defined as at least a 50% reduction in 24-hour pad weight from baseline to 12-months (including dry as defined as a pad weight of less than 1.3 grams during the 12-month test). *Safety: Safety of the device, including the implant procedure, will be characterized by reporting adverse events including complications such as, but not limited to perforation, erosion, and hematoma, at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives will assess subject satisfaction, patient reported pad use, and change in 24 hour pad weight through 36 months. Secondary End Points: The following secondary endpoints will be collected during the investigation. As labeling claims will not be made on these endpoints, formal statistical hypothesis tests are not specified and no adjustment of p-values for multiplicity is required. Subjects will be stratified into the three groups below by their 24 hour pad weight. *24 Hour Pad Weight: 24 hour pad weight tests will be administered at baseline, 1, 3, 6, 12, 24 and 36 months and the difference reported. Outcomes reported will include mean paired change from baseline as well as the proportion or patients improving by at least 50% from baseline. For this purpose, results will be reported overall and by level of incontinence at baseline, divided into these specific categories: *Group 1 ( 400 g) *Pad Use: Number and types of pads used will be collected at baseline,1, 3, 6, 12, 24 and 36 months and the difference reported. For this purpose, results will be reported overall and by level of incontinence at baseline, divided into these specific categories: According to the number of pad: *Group A (0 or 1 dry pad for security / prophylactic reason) *Group B (1 or 2 pads per day) *Group C (3 or 4 pads per day) *Group D (5 or more pads per day or condom catheter) *ICIQ-UI: The ICIQ patient questionnaire will be administered at baseline, 1, 3, 6, 12, 24 and 36 months and the difference reported. *PGI-I: The PGI-I patient questionnaire will be administered at 1, 3, 6, 12, 24 and 36 months and the patient reported improvement in urinary incontinence reported. *USP questionnaire: The USP patient questionnaire will be administered at baseline, 1, 3, 6, 12, 24 and 36 months and help to score the stress urinary incontinence, bladder overactivity and dysuria *Patient satisfaction score: The patient satisfaction will be evaluated at each | — |
Countries
Netherlands
Outcome results
None listed