Virtue® Male Sling Fixation Study

Study Overview
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Brief Summary
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This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

Official Title
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Virtue® Male Sling Fixation Study

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Coloplast Virtue® Male Sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subject at least 18 years of age with an estimated life expectancy of of more than 5 years The subject has confirmed stress urinary incontinence (SUI) through medical history , urodynamics, and/or physical exam for at least 6 months The subject has completed post-void residual per protocol within 6 weeks prior to implant The subject has completed cystoscopy as per protocol within 12 months prior to implant The subject has intrinsic sphincter deficiency due to one of the following: post-transurethral resection of the prostate (TURP), simple open prostatectomy, or radical prostatectomy completed at least 6 months prior to implantation date The subject has failed at least two non-invasive therapies, eg. pelvic/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 the protocol The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics committee of the respective site Exclusion Criteria: The subject is unable or unwilling to sign the informed consent form (ICF)and/or 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 serious bleeding disorders The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, cerebrovascular accident (CVA), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar condition The subject had a previous implant to treat stress urinary incontinence The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months The subject is likely to undergo radiation therapy within the next 6 months The subject has active urethral or bladder neck stricture disease requiring continued treatment The subject has urge predominant incontinence The subject has an atonic bladder or a postvoid residual (PVR) greater than or equal to 150 milliliters (mL) The subject has a condition or disorder likely to require future transurethral procedure The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without sponsor's approval The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by attending physician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Virtue® Male Sling<br>Device: Coloplast Virtue® Male Sling | Device: Coloplast Virtue® Male Sling<br>* The Virtue Male sling is a class II single use implantable sub-urethral, permanent, non-absorbable, support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of incontinence |  | 3 months post implant | 
| Safety of the device characterized by reported adverse events |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize incontinence severity at various time points |  | 24 months | 
| To evaluate patient quality of life at specified time points |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Sling, Fixation, Stress Urinary Incontinence, Urinary incontinence