URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
- Conditions
- Overactive Bladder With Urge Urinary Incontinence
- Interventions
- Drug: Placebo
- Registration Number
- NCT04211831
- Lead Sponsor
- Urovant Sciences GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1: URO-902 24 mg; Placebo URO-902 Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo. Cohort 1: URO-902 24 mg; Placebo Placebo Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo. Cohort 2: URO-902 48 mg; Placebo Placebo Participants will receive either a single treatment of URO-902 48 mg or matching placebo. Cohort 2: URO-902 48 mg; Placebo URO-902 Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
- Primary Outcome Measures
Name Time Method Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes Baseline (Day 1) and at Week 12 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Up to Week 48 An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant, administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize participant and may require medical or surgical intervention to prevent any of outcomes listed above. TEAEs/TESAEs are defined as any event that began or worsened in severity after initial exposure of study treatment through 48 weeks after treatment administration or the date of the initiation of another overactive bladder medication, investigational agent, or surgical intervention, whichever occurred first.
Trial Locations
- Locations (20)
University of Southern California - Norris Hospital
🇺🇸Los Angeles, California, United States
Orange County Urology Associates
🇺🇸Laguna Hills, California, United States
Institute For Female Pelvic Medicine
🇺🇸Allentown, Pennsylvania, United States
Urology Center of Englewood
🇺🇸Englewood, New Jersey, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States
Tri Valley Urology Medical Group
🇺🇸Murrieta, California, United States
Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Bay State Clinical Trials
🇺🇸Watertown, Massachusetts, United States
Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
Chesapeake Urology Associates
🇺🇸Hanover, Maryland, United States
Precision Clinical Research LLC
🇺🇸Sunrise, Florida, United States
Atrium Healthcare
🇺🇸Charlotte, North Carolina, United States
Accumed Research Associates - ClinEdge - PPDS
🇺🇸Garden City, New York, United States
Urology Specialists of The Carolinas
🇺🇸Huntersville, North Carolina, United States
Great Lakes Physician PC / Western New York Urology Associates
🇺🇸Cheektowaga, New York, United States
Premier Urology Group, LLC
🇺🇸Edison, New Jersey, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Washington Urology & Urogynecology Associates
🇺🇸Kirkland, Washington, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States