Solace Stress Urinary inContinence Control Efficacy and Safety Study

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT02210273
• Lead Sponsor: Solace Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Study Start: 2014-08-11
• Primary Completion: 2015-12-18
• Disposition First Submitted: 2017-11-15
• Disposition First Submitted QC: 2017-11-15
• Disposition First Posted: 2017-11-17
• Study Completion: 2019-03-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 221

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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.

Trial Locations

Locations (18)

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; 🇺🇸 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

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