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

Completed · Phase 3 · Has a placebo group

Conditions studied: Urinary Incontinence, Stress

In brief

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.

Key facts

Study ID

NCT00492596

Run by

Solace Therapeutics, Inc.

People needed

166

Starts

2006-06-01

Expected to finish

2011-06-01

Last updated by the study team

2014-08-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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