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ACTIVE NOT RECRUITING
NCT03323554
NA

Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

Sponsor: Quanta Medical

View on ClinicalTrials.gov

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

Interventions

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).

Locations (1)

CHU Charles Nicolle

Rouen, France