Clinical trial NCT02210273: Solace Stress Urinary inContinence Control Efficacy and Safety Study
Official title: Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
SUI
Lead sponsor: Solace Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
timeFrame: 3 Months
Secondary outcomes:
measure: Incidence of treatment-related adverse events
timeFrame: 3 Months
measure: Severity of treatment-related adverse events
timeFrame: 3 Months
Other outcomes:
measure: Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
timeFrame: 36 Months
measure: Severity of all adverse events
timeFrame: 36 Months
Locations:
city: Phoenix
country: United States
facility: Valley Urogynecology Associates
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Norwalk
country: United States
facility: Urology Associates of Norwalk
state: Connecticut
city: Arlington Heights
country: United States
facility: WomanCare
state: Illinois
city: Oak Lawn
country: United States
facility: Women's Health Institute of Illinois
state: Illinois
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Glen Burnie
country: United States
facility: Chesapeake Urology
state: Maryland
city: Owings Mills
country: United States
facility: Chesapeake Urology
state: Maryland
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine and Urogynecology Institute of Michigan
state: Michigan
city: Great Neck
country: United States
facility: North Shore LIJ
state: New York
city: Newburgh
country: United States
facility: Premier Medical Group
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group
state: New York
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Charleston
country: United States
facility: MUSC Urology
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
state: South Dakota
city: Richmond
country: United States
facility: Virginia Women's Center
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
Study officials:
affiliation: Medical University of South Carolina
name: Eric Rovner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.