Solace Stress Urinary inContinence Control Efficacy and Safety Study

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.

Inclusion Criteria:

- 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 Criteria:

- 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)