Clinical trial NCT00492596: The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence
Official title: An Evaluation of the AttenueX IntraVesical System in the Management of Female Subjects With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence, Stress
Lead sponsor: Solace Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Stamey Grade
timeFrame: 6-months
Secondary outcomes:
measure: Pad Weight
timeFrame: 6-months
measure: VLPP
timeFrame: 6-months
measure: I-QOL
timeFrame: 6-months
measure: Incontinence Episode Frequency
timeFrame: 6-months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Urologic Specialists
state: Arizona
city: Downey
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Los Angeles
country: United States
facility: Tower Urology Institute for Incontinence
state: California
city: San Diego
country: United States
facility: Saad Juma Inc.
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Ft. Lauderdale
country: United States
facility: Oak Ridge Medical Plaza
state: Florida
city: Atlanta
country: United States
facility: Midtown Urology, P.C.
state: Georgia
city: Morristown
country: United States
facility: Atlantic Health Systems
state: New Jersey
city: Albany
country: United States
facility: Northeast Urogynecology
state: New York
city: Charleston
country: United States
facility: Medical University of Southern Carolina
state: South Carolina
city: Houston
country: United States
facility: Vanguard Urologic Institute
state: Texas
city: Seattle
country: United States
facility: Integrity Medical Research
state: Washington
Study officials:
References: