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Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence
Sponsor: Quanta Medical
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 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: Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. an Open, Randomised, Multicentre Study Versus Artificial Sphincter.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2018-06-01
Completion Date
2026-12-01
Last Updated
2025-03-20
Healthy Volunteers
No
Conditions
Interventions
Ustrap®
Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.
AMS 800®
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).
Locations (1)
CHU Charles Nicolle
Rouen, France