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Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II)

NCT02288455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-11-22

No results posted yet for this study

Summary

The purpose of this investigation is to demonstrate the safety and efficacy of the GTU artificial urinary sphincter device in restoring continence in males who have confirmed urinary stress incontinence for a minimum of 12 months with primary etiology being radical prostatectomy or transurethral resection of the prostate (TURP).

Conditions

  • Male Stress Urinary Incontinence

Interventions

DEVICE

GTU Artificial Urinary Sphincter

A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)

Sponsors & Collaborators

  • GT Urological, LLC

    lead INDUSTRY

Principal Investigators

  • Olivier Haillot · Hôpitaux de Tours

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-11-20
Completion
2017-11-20

Countries

  • Australia
  • Czechia
  • New Zealand

Study Locations

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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 NCT02288455 on ClinicalTrials.gov