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

Primary Purpose

Overactive Bladder With Urge Urinary Incontinence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
URO-902
Placebo
Sponsored by
Urovant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder With Urge Urinary Incontinence focused on measuring URO-902, hMaxi-K, pVAX/hSlo, Overactive Bladder, Urge Urinary Incontinence

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Coastal Clinical Research Inc
  • Urological Associates of Southern Arizona
  • Orange County Urology Associates
  • University of Southern California - Norris Hospital
  • Tri Valley Urology Medical Group
  • Stanford University School of Medicine
  • Precision Clinical Research LLC
  • Iowa Clinic
  • Chesapeake Urology Associates
  • Bay State Clinical Trials
  • Beaumont Hospital
  • Premier Urology Group, LLC
  • Urology Center of Englewood
  • Great Lakes Physician PC / Western New York Urology Associates
  • Accumed Research Associates - ClinEdge - PPDS
  • Atrium Healthcare
  • Urology Specialists of The Carolinas
  • Institute For Female Pelvic Medicine
  • Urology of Virginia
  • Washington Urology & Urogynecology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1: URO-902 24 mg; Placebo

Cohort 2: URO-902 48 mg; Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 23, 2019
Last Updated
March 29, 2023
Sponsor
Urovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04211831
Brief Title
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
Official Title
An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urovant Sciences GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder With Urge Urinary Incontinence
Keywords
URO-902, hMaxi-K, pVAX/hSlo, Overactive Bladder, Urge Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: URO-902 24 mg; Placebo
Arm Type
Experimental
Arm Description
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
Arm Title
Cohort 2: URO-902 48 mg; Placebo
Arm Type
Experimental
Arm Description
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
Intervention Type
Drug
Intervention Name(s)
URO-902
Other Intervention Name(s)
hMaxi-K, pVAX/hSlo
Intervention Description
intradetrusor injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intradetrusor injection
Primary Outcome Measure Information:
Title
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes
Description
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.
Time Frame
Baseline (Day 1) and at Week 12
Secondary Outcome Measure Information:
Title
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Description
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.
Time Frame
Up to Week 48

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanh Badger, PharmD
Organizational Affiliation
Urovant Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Urological Associates of Southern Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Orange County Urology Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
University of Southern California - Norris Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Precision Clinical Research LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Chesapeake Urology Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Bay State Clinical Trials
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Premier Urology Group, LLC
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Urology Center of Englewood
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Great Lakes Physician PC / Western New York Urology Associates
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
Accumed Research Associates - ClinEdge - PPDS
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Atrium Healthcare
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Urology Specialists of The Carolinas
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Institute For Female Pelvic Medicine
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Washington Urology & Urogynecology Associates
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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