Virtue® Male Incontinence Sling Study

Study Overview
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Brief Summary
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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.

Official Title
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Virtue® Male Incontinence Sling Study

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Virtue® Male Incontinence Sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

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 |
| --- | --- |
| Other: Virtue® Male Sling<br>Subjects implanted with Virtue® Male Sling | Device: Virtue® Male Incontinence Sling<br>* The VIRTUE® male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) | Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding very much better or much better. | 12 months post implant | 
| Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry). | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Change in Subject Satisfaction Through ICIQ | 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. | Baseline | 
| Assess Change in Subject Satisfaction Through ICIQ | 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. | 12 months post implant | 
| Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother | 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. | Baseline | 
| Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother | 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. | 12 months post implant | 
| Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function | 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. | Baseline | 
| Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function | 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. | 12 months post implant | 
| Assess Change in Pad Use | Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment. | Baseline | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male sling, stress urinary incontinence, urinary incontinence