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

August 7, 2014 updated by: Solace Therapeutics, Inc.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Urologic Specialists
    • California
      • Downey, California, United States, 90242
        • Kaiser Permanente Medical Center
      • Los Angeles, California, United States, 90048
        • Tower Urology Institute for Incontinence
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Center
      • San Diego, California, United States, 92024
        • Saad Juma Inc.
    • Colorado
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • Oak Ridge Medical Plaza
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Midtown Urology, P.C.
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health Systems
    • New York
      • Albany, New York, United States, 12205
        • Northeast Urogynecology
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of Southern Carolina
    • Texas
      • Houston, Texas, United States, 77054
        • Vanguard Urologic Institute
    • Washington
      • Seattle, Washington, United States, 98133
        • Integrity Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female subjects ≥ 18 years of age
  • Experienced stress urinary incontinence (SUI) for at least 12-months and failed prior non-surgical treatment
  • VLPP ≥ 60cm H20
  • Stamey Grade ≥ 1
  • Free of local skin infection, impassable urethral strictures, trauma or necrosis
  • Provide written informed consent

Exclusion Criteria:

  • Pregnant or planning pregnancy
  • 3 or more urinary tract infections within previous year
  • Intrinsic sphincter deficiency
  • Incontinence surgery within previous 6-months
  • Cystocele ≥ grade 3
  • Previous pelvic radiation therapy
  • Presence of urethral abnormalities
  • Recent urosepsis
  • History of interstitial or follicular cystitis
  • Uncontrolled diabetes
  • Biofeedback within previous 3 months
  • Morbid obesity
  • Use of anticoagulants other than aspirin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: device
insertion of balloon system
Insertion of the Solace AttenueX Intravesical System on Day 0
Other Names:
  • Solace Balloon
Sham Comparator: sham
cystoscopy with sham system
Insertion of the Solace AttenueX Intravesical System on Day 0
Other Names:
  • Solace Balloon
Cystoscopy with Simulated Insertion of AttenuEX Intravescial System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stamey Grade
Time Frame: 6-months
6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pad Weight
Time Frame: 6-months
6-months
VLPP
Time Frame: 6-months
6-months
I-QOL
Time Frame: 6-months
6-months
Incontinence Episode Frequency
Time Frame: 6-months
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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