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Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

NCT03323554 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-20

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Cousin Biotech

    collaborator INDUSTRY

  • Quanta Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323554 on ClinicalTrials.gov