The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence
- Conditions
- Urinary Incontinence, Stress
- Interventions
- Device: AttenueX IntraVesical SystemProcedure: Sham Procedure
- Registration Number
- NCT00492596
- Lead Sponsor
- Solace Therapeutics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 166
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description sham AttenueX IntraVesical System cystoscopy with sham system sham Sham Procedure cystoscopy with sham system device AttenueX IntraVesical System insertion of balloon system
- Primary Outcome Measures
Name Time Method Stamey Grade 6-months
- Secondary Outcome Measures
Name Time Method I-QOL 6-months VLPP 6-months Pad Weight 6-months Incontinence Episode Frequency 6-months
Trial Locations
- Locations (12)
Arizona Urologic Specialists
🇺🇸Tucson, Arizona, United States
Kaiser Permanente Medical Center
🇺🇸San Diego, California, United States
Genitourinary Surgical Consultants
🇺🇸Denver, Colorado, United States
Tower Urology Institute for Incontinence
🇺🇸Los Angeles, California, United States
Saad Juma Inc.
🇺🇸San Diego, California, United States
Oak Ridge Medical Plaza
🇺🇸Ft. 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