NCT03323554

Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Quanta Medical · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Ustrap®	Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.
DEVICE	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).

Timeline

• Start date: 2018-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-10-27
• Last updated: 2025-03-20

Locations

1 site across 1 country: France