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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00492596
First received: June 25, 2007
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence, Stress
Device: AttenueX IntraVesical System
Procedure: Sham Procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Solace Therapeutics, Inc.:

Primary Outcome Measures:
  • Stamey Grade [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pad Weight [ Time Frame: 6-months ] [ Designated as safety issue: No ]
  • VLPP [ Time Frame: 6-months ] [ Designated as safety issue: No ]
  • I-QOL [ Time Frame: 6-months ] [ Designated as safety issue: No ]
  • Incontinence Episode Frequency [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: June 2006
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: device
insertion of balloon system
Device: AttenueX IntraVesical System
Insertion of the Solace AttenueX Intravesical System on Day 0
Other Name: Solace Balloon
Sham Comparator: sham
cystoscopy with sham system
Device: AttenueX IntraVesical System
Insertion of the Solace AttenueX Intravesical System on Day 0
Other Name: Solace Balloon
Procedure: Sham Procedure
Cystoscopy with Simulated Insertion of AttenuEX Intravescial System

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492596

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

No publications provided

Responsible Party: Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00492596     History of Changes
Other Study ID Numbers: SOL2004-001
Study First Received: June 25, 2007
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014