Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence
Lead Sponsor:
Quanta Medical
Collaborating Sponsors:
Cousin Biotech
Conditions:
Urinary Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03323554
Start Date
June 1 2018
End Date
December 1 2026
Last Update
March 20 2025
Active Locations (1)
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1
CHU Charles Nicolle
Rouen, France, 76031