Clinical trial NCT04211831: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder With Urge Urinary Incontinence
Keywords: URO-902
hMaxi-K
pVAX/hSlo
Overactive Bladder
Urge Urinary Incontinence
Lead sponsor: Urovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2019-12-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes
timeFrame: Baseline (Day 1) and at Week 12
Secondary outcomes:
measure: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Laguna Hills
country: United States
facility: Orange County Urology Associates
state: California
city: Los Angeles
country: United States
facility: University of Southern California - Norris Hospital
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Sunrise
country: United States
facility: Precision Clinical Research LLC
state: Florida
city: West Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: Hanover
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Watertown
country: United States
facility: Bay State Clinical Trials
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Edison
country: United States
facility: Premier Urology Group, LLC
state: New Jersey
city: Englewood
country: United States
facility: Urology Center of Englewood
state: New Jersey
city: Cheektowaga
country: United States
facility: Great Lakes Physician PC / Western New York Urology Associates
state: New York
city: Garden City
country: United States
facility: Accumed Research Associates - ClinEdge - PPDS
state: New York
city: Charlotte
country: United States
facility: Atrium Healthcare
state: North Carolina
city: Huntersville
country: United States
facility: Urology Specialists of The Carolinas
state: North Carolina
city: Allentown
country: United States
facility: Institute For Female Pelvic Medicine
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Kirkland
country: United States
facility: Washington Urology & Urogynecology Associates
state: Washington
Study officials:
affiliation: Urovant Sciences
name: Hanh Badger, PharmD
role: STUDY_DIRECTOR
References: