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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Urovant Sciences GmbH

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)