Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

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