Urinary Incontinence, Stress
Conditions
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.
Interventions
DEVICEAttenueX IntraVesical System
Insertion of the Solace AttenueX Intravesical System on Day 0
PROCEDURESham Procedure
Cystoscopy with Simulated Insertion of AttenuEX Intravescial System
Sponsors
Solace Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stamey Grade | 6-months |
Secondary
| Measure | Time frame |
|---|---|
| I-QOL | 6-months |
| Incontinence Episode Frequency | 6-months |
| VLPP | 6-months |
| Pad Weight | 6-months |
Countries
United States
Outcome results
None listed