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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Solace Therapeutics, Inc.. Recruitment status was Active, not recruiting

First Received on June 25, 2007. Last Updated on February 20, 2009 History of Changes

Sponsor:	Solace Therapeutics, Inc.
Information provided by:	Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00492596

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	Phase III

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:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence Urine and Urination

U.S. FDA Resources

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 ]

Estimated Enrollment:	165
Study Start Date:	June 2006

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

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:	CEO, Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00492596 History of Changes
Other Study ID Numbers:	SOL2004-001
Study First Received:	June 25, 2007
Last Updated:	February 20, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders

Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012