AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence

Study Overview
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Brief Summary
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The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.

Official Title
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Randomised Clinical Trial to Evaluate Efficacy of AdVance® vs ARGUS® Sling Procedure in Male With Post Prostatectomy Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: AdVance® sling procedure
* Procedure: ARGUS Sling procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is male The subject 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) through medical history, urodynamics, and/or physical exam for at least 6 months The subject has intrinsic sphincter deficiency due to one of the following: post-TURP, simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date Positive Cough Stress Test (CST): Positive 24-hours Pad Test (PT): A positive PT is confirmed with leakage of >8.O g/24h and < 400 g The subject has completed urodynamics, uroflow, post-void residual, and cystoscopy as per the protocol within 6 months prior to implant The subject is able and willing to complete all follow-up visits and procedures indicated in this 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 commit-tee of the respective site Exclusion Criteria: Subjects who meet any of the following criteria are excluded from entry into the study 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 urogenital 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, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions 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) ≥150mL The subject has a condition or disorder likely to require future transurethral procedure The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsors'approval Subjects who in the opinion of the investigator are unable and/or unlikely to to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AdVance<br>sling procedure | Procedure: AdVance® sling procedure<br> <br> |
| Active Comparator: ARGUS<br>sling procedure | Procedure: ARGUS Sling procedure<br> <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) score and assess change in 24-hour pad weight . |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, post prostatectomy