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

Solace Therapeutics

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence, Stress

Treatments: Procedure: Sham Procedure; Device: AttenueX IntraVesical System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492596

SOL2004-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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166 participants in 2 patient groups

device

Experimental group

Description:

insertion of balloon system

Treatment:

Device: AttenueX IntraVesical System

sham

Sham Comparator group

Description:

cystoscopy with sham system

Treatment:

Device: AttenueX IntraVesical System

Procedure: Sham Procedure