Solace Stress Urinary inContinence Control Efficacy and Safety Study
SUCCESS
Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
1 other identifier
interventional
221
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedStudy Start
First participant enrolled
August 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedJuly 10, 2019
July 1, 2019
1.4 years
August 4, 2014
July 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Incidence of treatment-related adverse events
3 Months
Severity of treatment-related adverse events
3 Months
Other Outcomes (2)
Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
36 Months
Severity of all adverse events
36 Months
Study Arms (2)
Treatment
EXPERIMENTALSubjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0
Solace Sham Treatment
SHAM COMPARATORSubjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months
Interventions
Subjects may undergo treatment every 12 months until study completion.
Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Valley Urogynecology Associates
Phoenix, Arizona, 85016, United States
Urological Associates of Southern Arizona
Tucson, Arizona, 85715, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Urology Associates of Norwalk
Norwalk, Connecticut, 06850, United States
WomanCare
Arlington Heights, Illinois, 60004, United States
Women's Health Institute of Illinois
Oak Lawn, Illinois, 60453, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Chesapeake Urology
Glen Burnie, Maryland, 21061, United States
Chesapeake Urology
Owings Mills, Maryland, 21117, United States
Female Pelvic Medicine and Urogynecology Institute of Michigan
Grand Rapids, Michigan, 49503, United States
North Shore LIJ
Great Neck, New York, 11021, United States
Premier Medical Group
Newburgh, New York, 12550, United States
Premier Medical Group
Poughkeepsie, New York, 12601, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
MUSC Urology
Charleston, South Carolina, 29425, United States
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105, United States
Virginia Women's Center
Richmond, Virginia, 23233, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
Integrity Medical Research
Mountlake Terrace, Washington, 98043, United States
Related Publications (1)
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.
PMID: 29095516DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Rovner, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 6, 2014
Study Start
August 11, 2014
Primary Completion
December 18, 2015
Study Completion
March 30, 2019
Last Updated
July 10, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share
Individual records will not be made available to honor contracts with Investigators.