NCT00492596

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

An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Solace Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the AttenueX Device in reducing incontinence. Subjects randomized to the control arm will have the AttenueX Device inserted at the end of the 3-month control period. For those subjects who are randomized to the treatment group, the AttenueX Device will be inserted into the bladder on Day 0, and replaced every 90 days by a new device for nine months. Subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the AttenueX Device, while subjects randomized into the control group will be followed for 3 months without the AttenueX Device and a minimum of 12 months after receiving the AttenueX Device.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2007-06-27
• Last updated: 2014-08-11

Locations

13 sites across 1 country: United States