Solace Stress Urinary inContinence Control Efficacy and Safety Study

Stress Urinary Incontinence Clinical Trial

— SUCCESS  

Official title:

Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210273
• Other study ID #: CD1001
• Status: Completed
• Phase: N/A
• Start date: August 11, 2014
• Est. completion date: March 30, 2019

Study information

• Verified date: July 2019
• Source: Solace Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: March 30, 2019
• Est. primary completion date: December 18, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Solace Bladder Control (Vesair) Balloon
Subjects may undergo treatment every 12 months until study completion.
• Solace Sham Treatment
Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon

Locations

Country	Name	City	State
United States	WomanCare	Arlington Heights	Illinois
United States	MUSC Urology	Charleston	South Carolina
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Chesapeake Urology	Glen Burnie	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	Integrity Medical Research	Mountlake Terrace	Washington
United States	Premier Medical Group	Newburgh	New York
United States	Urology Associates of Norwalk	Norwalk	Connecticut
United States	Women's Health Institute of Illinois	Oak Lawn	Illinois
United States	Chesapeake Urology	Owings Mills	Maryland
United States	Valley Urogynecology Associates	Phoenix	Arizona
United States	Premier Medical Group	Poughkeepsie	New York
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Virginia Women's Center	Richmond	Virginia
United States	Regional Urology	Shreveport	Louisiana
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 of Virginia	Virginia Beach	Virginia
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Solace Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in quality of life in all patients assessed with pad weight tests and questionnaires	Comparison of increases in pad weight test and patient reported outcomes on questionnaires	36 Months
Other	Severity of all adverse events	Site-reported adverse events designated as related to the treatment.	36 Months
Primary	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	3 Months
Secondary	Incidence of treatment-related adverse events	Site-reported adverse events designated as related to the treatment	3 Months
Secondary	Severity of treatment-related adverse events	Site-reported adverse events designated as related to the treatment.	3 Months