Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

Study Overview
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Brief Summary
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Few surgical methods to treat male stress urinary incontinence have been assessed in comparative, randomised interventional studies. Ustrap is a new adjustable-pressure 4-arm device. The artificial sphincter is currently considered the gold standard device in this field. The aim of this randomised prospective international study is to assess the efficacy and safety of the Ustrap® device comparatively with an artificial sphincter (AMS800) in the treatment of stress urinary incontinence following prostate removal in cancer patients.

Official Title
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Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. An Open, Randomised, Multicentre Study Versus Artificial Sphincter.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Ustrap®
* Device: AMS 800®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disease-related criteria: persistent urinary incontinence >= 12 months following radical prostatectomy for prostate adenocarcinoma presenting an indication for surgical insertion of a medical device 24h PAD test > 100 g per day controlled prostate adenocarcinoma, with PSA ≤ 1 ng/ml Population-related criteria: male subjects aged 18 years and over having provided free, informed written consent to take part in the study patients independent and able to use the collar without difficulty and able to manage an artificial sphincter Patient able to understand and sign the consent form and to complete questionnaires Patient without mental impairment Patients belonging to or covered by Social Security. Exclusion Criteria: Disease-related criteria: Documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms. Presence of urethral anastomotic stenosis preventing passage of the fiberscope at the initial endoscopy Severe symptomatic hyperactive or hypoactive bladder not controlled by drug therapy Severe constitutional haemorrhagic disease or haemophilia Patients presenting urinary infection not controlled Patients presenting severe renal failure and obstructive pathologies of the upper urinary tract with severe renal failure. Patients presenting deep immune deficiency Patient presenting recto-urethral fistula Patient with tumor of bladder Patient having bladder stones with failure of bladder stone treatment Criteria related to incontinence treatment: Allergy to any of the components of the medical devices History of surgery to insert a medical device for treatment of incontinence (e.g. artificial sphincter, suburethral strap, continence balloons, etc.) History of periurethral injection of filling agents Inability to use either of the study devices Drug treatment: duloxetine or any treatment likely to modify continence results Not receiving and not likely to receive radiotherapy at any time throughout the 12-month follow-up period Population-related criteria Foreseeable unavailability during the study . Patient deprived of liberty by administrative or judicial decision or under legal guardianship Participation in another clinical trial in the 3 months preceding the initial visit

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
Interventional Model Description: a prospective, randomised, multicentre, comparative, open label, non-inferiority study in parallel groups of patients presenting stress urinary incontinence following prostate ablation for cancer.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ustrap®<br>Ustrap is a new adjustable-pressure 4-arm device | Device: Ustrap®<br>* Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.<br>|
| Active Comparator: AMS 800®<br>Artificial sphincter currently considered the gold standard device in this field | Device: AMS 800®<br>* Patients will receive AMS 800® under general or loco-regional anaesthesia. Small openings are made near the scrotum and below the abdomen to insert an inflatable cuff, a pump and a small balloon (pressure regulating balloon).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of succes rate | Succes being defined as the absence of use of protective pads, or in the case of use of safety protection comprising a test PAD over 24h, wet weight indicating collection of ≤ 10 g liquid, and the absence of corrective surgery. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radical prostatectomy , Device,