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The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence

NCT00492596 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2014-08-11

No results posted yet for this study

Summary

Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing. SUI affects women of all ages and can result in significant emotional distress. The purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.

Conditions

  • Urinary Incontinence, Stress

Interventions

DEVICE

AttenueX IntraVesical System

Insertion of the Solace AttenueX Intravesical System on Day 0

PROCEDURE

Sham Procedure

Cystoscopy with Simulated Insertion of AttenuEX Intravescial System

Sponsors & Collaborators

  • Solace Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • United States

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 NCT00492596 on ClinicalTrials.gov