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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TERMINATED
NA
158 participants
INTERVENTIONAL
2020-02-01
2022-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vesair
Subjects are treated with Vesair Balloon at enrollment (day 0)
Vesair Balloon
Indwelling, intravesical balloon
Sham
Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
Vesair Balloon
Indwelling, intravesical balloon
Sham balloon placement
Sham balloon placement procedure
Interventions
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Vesair Balloon
Indwelling, intravesical balloon
Sham balloon placement
Sham balloon placement procedure
Eligibility Criteria
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Inclusion Criteria
* Average of at least one leak per day
* Failed non-invasive treatment
* Willing to undergo cystoscopy and a minimum of 5 visits over one year
Exclusion Criteria
* Last menstrual period within 12 months of enrollment
* On birth control and/or oral hormone replacement therapy
* Urge-predominant mixed incontinence
* SUI due to intrinsic sphincter deficiency
* Prior treatment with the Vesair Balloon
* Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment
* Recurrent or recent (within the past 5 years) kidney stones
* Recurrent or recent (within the past 3 months) Urinary Tract Infection
* Stage 3 or higher cystocele (POP-Q)
* Interstitial or follicular cystitis / painful bladder syndrome
* Local genital infection
* Artificial sphincter
* Anatomic abnormalities which would interfere with device placement.
* Visible blood in the urine
* Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc
* History of cancer of the urinary tract
* History of any cancer within the past two years (excluding non-melanoma skin cancers)
* History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers)
* Immunologically suppressed or immunocompromised
* Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation
* Non ambulatory / unable to do simple pad weight testing exercises
* On anticoagulation therapy with the exception of aspirin
* History of mental illness requiring inpatient treatment
* Neurological disease such as Parkinson's or multiple sclerosis
* Uncontrolled diabetes (A1C \> 9%)
* Recent alcohol or drug abuse requiring treatment in the past year
* Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis
* Allergy to polyurethane or perfluorocarbons
18 Years
FEMALE
No
Sponsors
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Solace Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Valley Urogynecology Associates
Phoenix, Arizona, United States
Scripps Clinic
San Diego, California, United States
Tri Valley Urology
Temecula, California, United States
Dr. Sherry Thomas
Westlake Village, California, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Florida Urology Partners
Tampa, Florida, United States
Meridian Clinical Research / Urological Associates of Savannah
Savannah, Georgia, United States
WomanCare
Arlington Heights, Illinois, United States
CMB Research / Basinski and Juran MDs
Newburgh, Indiana, United States
Regional Urology
Shreveport, Louisiana, United States
Chesapeake Urology
Hanover, Maryland, United States
Chesapeake Urology
Owings Mills, Maryland, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Mercy Health
Ada, Michigan, United States
Freedman Urology
Las Vegas, Nevada, United States
ProHEALTH Garden City Urology
Garden City, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
MetroHealth
Cleveland, Ohio, United States
Penn Medicine
Philadelphia, Pennsylvania, United States
Women and Infants dept of Urogynecology
Providence, Rhode Island, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Washington Urology
Kirkland, 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.
Related Links
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Company Website
Other Identifiers
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CD1010
Identifier Type: -
Identifier Source: org_study_id
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