Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Solace Therapeutics, Inc.
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | Solace Stress Urinary inContinence Control Efficacy and Safety Study
