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

An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder With Urge Urinary Incontinence
• Intervention / Treatment: Drug: URO-902; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research Inc
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Urological Associates of Southern Arizona
  • California
    • Laguna Hills, California, United States, 92653
      • Orange County Urology Associates
    • Los Angeles, California, United States, 90033
      • University of Southern California - Norris Hospital
    • Murrieta, California, United States, 92562
      • Tri Valley Urology Medical Group
    • Palo Alto, California, United States, 94304
      • Stanford University School of Medicine
  • Florida
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research LLC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Clinic
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Chesapeake Urology Associates
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Premier Urology Group, LLC
    • Englewood, New Jersey, United States, 07631
      • Urology Center of Englewood
  • New York
    • Cheektowaga, New York, United States, 14225
      • Great Lakes Physician PC / Western New York Urology Associates
    • Garden City, New York, United States, 11530
      • Accumed Research Associates - ClinEdge - PPDS
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Healthcare
    • Huntersville, North Carolina, United States, 28078
      • Urology Specialists of The Carolinas
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Institute for Female Pelvic Medicine
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia
  • Washington
    • Kirkland, Washington, United States, 98034
      • Washington Urology & Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Drug: URO-902; intradetrusor injection; Other Names: hMaxi-K; pVAX/hSlo; 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: hMaxi-K; pVAX/hSlo; Drug: Placebo; intradetrusor injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes	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.	Baseline (Day 1) and at Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	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.	Up to Week 48

Collaborators and Investigators

• Sponsor: Urovant Sciences GmbH
• Investigators: Study Director: Hanh Badger, PharmD, Urovant Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Overactive Bladder; Urge Urinary Incontinence; URO-902; hMaxi-K; pVAX/hSlo
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
• Other Study ID Numbers: URO-902-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No