Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT05547672

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men

First-in-human Study to Assess the UrOMems Artificial Urinary sPHincter In the treAtment of Stress Incontinence

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
UroMems SAS · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.

Detailed description

This study is a prospective, open-label, non-randomized, multi-center, single-arm, study with subjects acting as their own control designed to test the feasibility of a new artificial urinary sphincter the UroMems eAUS (investigational name of device called UroActive).

Conditions

Interventions

TypeNameDescription
DEVICEUroMems artificial urinary sphincterImplantation of the device

Timeline

Start date
2022-08-31
Primary completion
2023-11-30
Completion
2028-07-01
First posted
2022-09-21
Last updated
2026-04-01

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05547672. Inclusion in this directory is not an endorsement.