Solace Stress Urinary inContinence Control Efficacy and Safety Study

Not Applicable

Completed

Interventions: Device: Solace Bladder Control (Vesair) Balloon
Device: Solace Sham Treatment

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Solace Sham Treatment	Solace Bladder Control (Vesair) Balloon	Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months
Treatment	Solace Bladder Control (Vesair) Balloon	Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0
Solace Sham Treatment	Solace Sham Treatment	Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires	3 Months	Comparison of increases in pad weight test and patient reported outcomes on questionnaires

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-related adverse events	3 Months	Site-reported adverse events designated as related to the treatment
Severity of treatment-related adverse events	3 Months	Site-reported adverse events designated as related to the treatment.

Locations (18): Valley Urogynecology Associates
🇺🇸
Phoenix, Arizona, United States
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
🇺🇸
Sioux Falls, South Dakota, United States
Urological Associates of Southern Arizona
🇺🇸
Tucson, Arizona, United States
Urology Associates of Norwalk
🇺🇸
Norwalk, Connecticut, United States
Regional Urology
🇺🇸
Shreveport, Louisiana, United States
Women's Health Institute of Illinois
🇺🇸
Oak Lawn, Illinois, United States
Genitourinary Surgical Consultants
🇺🇸
Denver, Colorado, United States
WomanCare
🇺🇸
Arlington Heights, Illinois, United States
North Shore LIJ
🇺🇸
Great Neck, New York, United States
Female Pelvic Medicine and Urogynecology Institute of Michigan
🇺🇸
Grand Rapids, Michigan, United States
Chesapeake Urology
🇺🇸
Owings Mills, Maryland, United States
Premier Medical Group
🇺🇸
Poughkeepsie, New York, United States
Women and Infants Hospital
🇺🇸
Providence, Rhode Island, United States
MUSC Urology
🇺🇸
Charleston, South Carolina, United States
Virginia Women's Center
🇺🇸
Richmond, Virginia, United States
Integrity Medical Research
🇺🇸
Mountlake Terrace, Washington, United States
Urology of Virginia
🇺🇸
Virginia Beach, Virginia, United States
Lyndhurst Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States