Solace Stress Urinary inContinence Control Efficacy and Safety Study
Completed · Not applicable · Has a placebo group
Conditions studied: Stress Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT02210273
- Run by
- Solace Therapeutics, Inc.
- People needed
- 221
- Starts
- 2014-08-11
- Expected to finish
- 2019-03-30
- Last updated by the study team
- 2019-07-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Valley Urogynecology Associates — Phoenix, Arizona, United States
- Urological Associates of Southern Arizona — Tucson, Arizona, United States
- Genitourinary Surgical Consultants — Denver, Colorado, United States
- Urology Associates of Norwalk — Norwalk, Connecticut, United States
- WomanCare — Arlington Heights, Illinois, United States
- Women's Health Institute of Illinois — Oak Lawn, Illinois, United States
- Regional Urology — Shreveport, Louisiana, United States
- Chesapeake Urology — Glen Burnie, Maryland, United States
- Chesapeake Urology — Owings Mills, Maryland, United States
- Female Pelvic Medicine and Urogynecology Institute of Michigan — Grand Rapids, Michigan, United States
- North Shore LIJ — Great Neck, New York, United States
- Premier Medical Group — Newburgh, New York, United States
- Premier Medical Group — Poughkeepsie, New York, United States
- Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
- Women and Infants Hospital — Providence, Rhode Island, United States
- MUSC Urology — Charleston, South Carolina, United States
- Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic — Sioux Falls, South Dakota, United States
- Virginia Women's Center — Richmond, Virginia, United States
- Urology of Virginia — Virginia Beach, Virginia, United States
- Integrity Medical Research — Mountlake Terrace, Washington, United States
Full record on ClinicalTrials.gov
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