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A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

NCT06968741 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-27

No results posted yet for this study

Summary

Prospective, multicenter, single-arm study

Conditions

  • Stress Urinary Incontinence (SUI)

Interventions

DEVICE

Artificial Urinary Sphincter (AUS)

AUS implant

Sponsors & Collaborators

  • UroMems SAS

    lead INDUSTRY

Principal Investigators

  • Roshini Jain · UroMems SAS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2026-12-31
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States
  • France

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 NCT06968741 on ClinicalTrials.gov