MedTrace Logo

ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence

NCT02490917 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-11-20

No results posted yet for this study

Summary

The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.

Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day

Conditions

Interventions

DEVICE

ACT™ device

Implantation of the Adjustable Continence Therapy device ACT®

DEVICE

AMS 800 ™ device

Implantation of the artificial urinary sphincter AMS 800 ™

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • CHARTIER-KASTLER EMMANUEL, MD, PhD · Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-09-30
Completion
2019-12-31

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 NCT02490917 on ClinicalTrials.gov