URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
NCT ID: NCT04211831
Last Updated: 2023-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2019-12-16
2022-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: URO-902 24 mg; Placebo
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
URO-902
intradetrusor injection
Placebo
intradetrusor injection
Cohort 2: URO-902 48 mg; Placebo
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
URO-902
intradetrusor injection
Placebo
intradetrusor injection
Interventions
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URO-902
intradetrusor injection
Placebo
intradetrusor injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant experiences ≥ 1 episode of UUI per day.
* Participant has not been adequately managed with ≥ 1 oral or transdermal pharmacologic therapies for the treatment of their OAB symptoms.
Exclusion Criteria
* Participant has a predominance of stress incontinence in the opinion of the investigator, determined by participant history.
* Participant currently uses or plans to use medications or therapies to treat symptoms of OAB, including nocturia.
* Participants who have previously been treated with onabotulinumtoxinA for urological indications within 12 months of starting the Screening Bladder Diary, or any other toxin for urological indications, regardless of when treated (participants treated with onabotulinumtoxinA or other toxins for non-urological indications are eligible, regardless of when treated)
40 Years
79 Years
FEMALE
No
Sponsors
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Urovant Sciences GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Hanh Badger, PharmD
Role: STUDY_DIRECTOR
Urovant Sciences
Locations
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Coastal Clinical Research Inc
Mobile, Alabama, United States
Urological Associates of Southern Arizona
Tucson, Arizona, United States
Orange County Urology Associates
Laguna Hills, California, United States
University of Southern California - Norris Hospital
Los Angeles, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
Precision Clinical Research LLC
Sunrise, Florida, United States
Iowa Clinic
West Des Moines, Iowa, United States
Chesapeake Urology Associates
Hanover, Maryland, United States
Bay State Clinical Trials
Watertown, Massachusetts, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Premier Urology Group, LLC
Edison, New Jersey, United States
Urology Center of Englewood
Englewood, New Jersey, United States
Great Lakes Physician PC / Western New York Urology Associates
Cheektowaga, New York, United States
Accumed Research Associates - ClinEdge - PPDS
Garden City, New York, United States
Atrium Healthcare
Charlotte, North Carolina, United States
Urology Specialists of The Carolinas
Huntersville, North Carolina, United States
Institute For Female Pelvic Medicine
Allentown, Pennsylvania, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Washington Urology & Urogynecology Associates
Kirkland, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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URO-902-2001
Identifier Type: -
Identifier Source: org_study_id
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