Phase 2
N=80
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
Overactive Bladder With Urge Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT04211831 ↗Enrolled (actual)
80
Serious AEs
8.1%
Results posted
Apr 2023
Primary outcome: Primary: Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes — -1.13; -2.43; -3.37 Urgency episodes per day — p==0.1722
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- URO-902 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Urovant Sciences GmbH
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes |
-1.13; -2.43; -3.37 | =0.1722 |
| SECONDARY Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
14; 10; 14; 3; 1; 2 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04211831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.