Solace Stress Urinary inContinence Control Efficacy and Safety Study

Solace Therapeutics, Inc.221 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

221

Conditions

Stress Urinary Incontinence

Interventions

Solace Bladder Control (Vesair) BalloonDEVICE

Subjects may undergo treatment every 12 months until study completion.

Solace Sham TreatmentDEVICE

Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (20)

Valley Urogynecology Associates

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Improvement in quality of life as assessed by pad weight tests assessments and questionnaires

Comparison of increases in pad weight test and patient reported outcomes on questionnaires

Time frame: 3 Months

Secondary Outcomes

Incidence of treatment-related adverse events

Site-reported adverse events designated as related to the treatment

Time frame: 3 Months

Severity of treatment-related adverse events

Site-reported adverse events designated as related to the treatment.

Time frame: 3 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.