Status:
COMPLETED
Solace Stress Urinary inContinence Control Efficacy and Safety Study
Lead Sponsor:
Solace Therapeutics, Inc.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
Detailed Description
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months. All patients undergoing sham treatment are treated at 3 months.
Eligibility Criteria
Inclusion
- Female 18 years of age or older with stress urinary incontinence (SUI)
- Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment
- Willing to undergo cystoscopic procedures required and 36 month follow-up
- On stable medication for a minimum of 3 months
- Free of local genital skin infection
- Positive Pad Weight Test
- Free of impassable urethral strictures, trauma or necrosis
Exclusion
- Pregnant or planning to become pregnant during the study period
- Non-ambulatory or bedridden or physically unable to complete test exercises
- Morbidly obese (defined as BMI ≥ 40 kg/m2)
- Incontinence of neurogenic etiology
- Urge predominant Mixed Incontinence
- Bladder infection (including bladder inflammation or edema) or Urinary Tract Infection (UTI) within 3 months
- History of recurrent urinary tract infections
- Prior surgical procedure for incontinence within the past 6 months
- Is taking medications for urinary incontinence other than anticholinergics
- History of recurrent (\>1) or recent (within 5 years) kidney stone(s)
- Has a prosthetic heart valve
- Unable to tolerate any form of antibiotic
- Taking anticoagulation therapy, other than aspirin
- Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)
Key Trial Info
Start Date :
August 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT02210273
Start Date
August 11 2014
End Date
March 30 2019
Last Update
July 10 2019
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Valley Urogynecology Associates
Phoenix, Arizona, United States, 85016
2
Urological Associates of Southern Arizona
Tucson, Arizona, United States, 85715
3
Genitourinary Surgical Consultants
Denver, Colorado, United States, 80220
4
Urology Associates of Norwalk
Norwalk, Connecticut, United States, 06850