URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04211831 |
Recruitment Status :
Completed
First Posted : December 26, 2019
Results First Posted : April 20, 2023
Last Update Posted : April 20, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overactive Bladder With Urge Urinary Incontinence | Drug: URO-902 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence |
Actual Study Start Date : | December 16, 2019 |
Actual Primary Completion Date : | November 18, 2021 |
Actual Study Completion Date : | July 20, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1: URO-902 24 mg; Placebo
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
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Drug: URO-902
intradetrusor injection
Other Names:
Drug: Placebo intradetrusor injection |
Experimental: Cohort 2: URO-902 48 mg; Placebo
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
|
Drug: URO-902
intradetrusor injection
Other Names:
Drug: Placebo intradetrusor injection |
- Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes [ Time Frame: 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.
- Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: 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.

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Ages Eligible for Study: | 40 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211831

Study Director: | Hanh Badger, PharmD | Urovant Sciences |
Documents provided by Urovant Sciences GmbH:
Responsible Party: | Urovant Sciences GmbH |
ClinicalTrials.gov Identifier: | NCT04211831 |
Other Study ID Numbers: |
URO-902-2001 |
First Posted: | December 26, 2019 Key Record Dates |
Results First Posted: | April 20, 2023 |
Last Update Posted: | April 20, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
URO-902 hMaxi-K pVAX/hSlo Overactive Bladder Urge Urinary Incontinence |
Urinary Incontinence Enuresis Urinary Bladder, Overactive Urinary Incontinence, Urge Urination Disorders Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Male Urogenital Diseases Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders Urinary Bladder Diseases |