URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence
1 other identifier
interventional
80
1 country
20
Brief Summary
This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2019
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2019
CompletedFirst Submitted
Initial submission to the registry
December 23, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2022
CompletedResults Posted
Study results publicly available
April 20, 2023
CompletedApril 20, 2023
March 1, 2023
1.9 years
December 23, 2019
March 29, 2023
March 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes
Average daily number of urgency episodes was calculated as the total number of urgency episodes recorded on a completed diary day within the visit window divided by the number of days the Bladder Diary was filled out. An urgency episode was defined as when a participant answered "Yes" to the question "Need to urinate immediately" on the bladder diary electronic case report form (eCRF). If a participant had more than 1 bladder diary filled out on the same day, then all the urgency episodes were summed together. The denominator used for calculating the average number only counted the days in which there was at least 1 completed bladder diary day within the visit window. Baseline was defined as the last non-missing measurement prior to the study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Baseline (Day 1) and at Week 12
Secondary Outcomes (1)
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Up to Week 48
Study Arms (2)
Cohort 1: URO-902 24 mg; Placebo
EXPERIMENTALParticipants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
Cohort 2: URO-902 48 mg; Placebo
EXPERIMENTALParticipants will receive either a single treatment of URO-902 48 mg or matching placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Participant has symptoms of Overactive Bladder (OAB) (frequency and urgency) with Urge Urinary Incontinence (UUI) for a period of at least 6 months prior to screening.
- 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.
You may not qualify if:
- Participant has symptoms of OAB due to any known neurological reason (e.g., spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Coastal Clinical Research Inc
Mobile, Alabama, 36608, United States
Urological Associates of Southern Arizona
Tucson, Arizona, 85715, United States
Orange County Urology Associates
Laguna Hills, California, 92653, United States
University of Southern California - Norris Hospital
Los Angeles, California, 90033, United States
Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
Precision Clinical Research LLC
Sunrise, Florida, 33351, United States
Iowa Clinic
West Des Moines, Iowa, 50266, United States
Chesapeake Urology Associates
Hanover, Maryland, 21076, United States
Bay State Clinical Trials
Watertown, Massachusetts, 02472, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Premier Urology Group, LLC
Edison, New Jersey, 08837, United States
Urology Center of Englewood
Englewood, New Jersey, 07631, United States
Great Lakes Physician PC / Western New York Urology Associates
Cheektowaga, New York, 14225, United States
Accumed Research Associates - ClinEdge - PPDS
Garden City, New York, 11530, United States
Atrium Healthcare
Charlotte, North Carolina, 28203, United States
Urology Specialists of The Carolinas
Huntersville, North Carolina, 28078, United States
Institute For Female Pelvic Medicine
Allentown, Pennsylvania, 18104, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
Washington Urology & Urogynecology Associates
Kirkland, Washington, 98034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Information, Clinical Trial Results
- Organization
- Urovant Sciences
Study Officials
- STUDY DIRECTOR
Hanh Badger, PharmD
Urovant Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2019
First Posted
December 26, 2019
Study Start
December 16, 2019
Primary Completion
November 18, 2021
Study Completion
July 20, 2022
Last Updated
April 20, 2023
Results First Posted
April 20, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share