Virtue® European Study

Study Overview
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Brief Summary
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This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

Detailed Description
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This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted at up to thirteen centers in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling. One hundred and twenty-one subjects, satisfying criteria for selection, will be implanted with no more than 15 implanted per site. The study's primary end point will be evaluated at 12 months with continued data collection through 36 months.

Official Title
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Virtue® Male Sling European Study

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Virtue® Male Sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has an estimated life expectancy 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 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: 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 (temporary exclusion) The subject has compromised immune systems or any other conditions that 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 TransUrethral Resection 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 agents are allowed) 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 3 months The subject has a postvoid residual (PVR) > or = 150mL 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 device) 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

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtue® Male Sling<br>Patient implanted Virtue® Male Sling | Device: Virtue® Male Sling<br>* The Coloplast Virtue® Male Sling is a Class II, 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of urinary incontinence based on 24-hour pad test | 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. | 1 year | 
| Safety of the device characterized by reported adverse events | Safety of the device, including the implant procedure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of urinary incontinence based on 24-hour pad test | 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 | Baseline, 1 month, 3 months, 6 months, 2 years, 3 years | 
| Improvement of urinary incontinence based on number of pad used | Number and types of pads used will be collected at baseline,1, 3, 6, 12, 24 and 36 months and the difference reported. | baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years | 
| Improvement of urinary incontinence based on PGI-I | Patient global Impression of improvement | 1 month, 3 months, 6 months, 1 year, 2 years, 3 years | 
| Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form | Base on International Consultation on Incontinence questionnaire-Urinary Incontinence short-form | baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years | 
| Patient satisfaction questionaire | the patient reported level of satisfaction in implantation sling procedure. | 1 month, 3 months, 6 months, 1 year, 2 years, 3 years | 
| Safety of the device characterized by reported adverse events | Safety of the device, including the implant procedure. | Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases