URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

Completed · Phase 2 · Has a placebo group

Conditions studied: Overactive Bladder With Urge Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT04211831

Run by

Urovant Sciences GmbH

People needed

80

Starts

2019-12-16

Expected to finish

2022-07-20

Last updated by the study team

2023-04-20

Who can join

Age: 40 and older, up to 79. Sex: female. Healthy volunteers: not accepted.

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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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