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

Urovant Sciences

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder With Urge Urinary Incontinence

Treatments: Drug: URO-902; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04211831

URO-902-2001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Cohort 1: URO-902 24 mg; Placebo

Experimental group

Description:

Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.

Treatment:

Drug: Placebo

Drug: URO-902

Cohort 2: URO-902 48 mg; Placebo

Experimental group

Description:

Participants will receive either a single treatment of URO-902 48 mg or matching placebo.

Treatment:

Drug: Placebo

Drug: URO-902