Solace Stress Urinary inContinence Control Efficacy and Safety Study
NCT ID: NCT02210273
Last Updated: 2019-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
221 participants
INTERVENTIONAL
2014-08-11
2019-03-30
Brief Summary
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Detailed Description
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All patients undergoing sham treatment are treated at 3 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment
Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0
Solace Bladder Control (Vesair) Balloon
Subjects may undergo treatment every 12 months until study completion.
Solace Sham Treatment
Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Solace Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Rovner, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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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
Glen Burnie, Maryland, 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
Premier Medical Group
Newburgh, New York, United States
Premier Medical Group
Poughkeepsie, New York, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Women and Infants Hospital
Providence, Rhode Island, United States
MUSC Urology
Charleston, South Carolina, United States
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
Sioux Falls, South Dakota, United States
Virginia Women's Center
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Integrity Medical Research
Mountlake Terrace, Washington, United States
Countries
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References
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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.
Other Identifiers
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CD1001
Identifier Type: -
Identifier Source: org_study_id
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