Overactive Bladder With Urge Urinary IncontinencePhase 2NCT04211831
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
A Phase 2 study testing URO-902 in people with Overactive Bladder With Urge Urinary Incontinence, run by Urovant Sciences GmbH at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years, women only
- Conditions the study is for
- Overactive Bladder With Urge Urinary Incontinence
- What is being tested?
- URO-902
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 20 sitesUnited States
- Study dates
- 16 Dec 2019to 20 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Institute For Female Pelvic Medicine
Allentown, Pennsylvania, 18104
Atrium Healthcare
Charlotte, North Carolina, 28203
Great Lakes Physician PC / Western New York Urology Associates
Cheektowaga, New York, 14225
Premier Urology Group, LLC
Edison, New Jersey, 08837
Urology Center of Englewood
Englewood, New Jersey, 07631
Accumed Research Associates - ClinEdge - PPDS
Garden City, New York, 11530
Chesapeake Urology Associates
Hanover, Maryland, 21076
Urology Specialists of The Carolinas
Huntersville, North Carolina, 28078
Washington Urology & Urogynecology Associates
Kirkland, Washington, 98034
Orange County Urology Associates
Laguna Hills, California, 92653
University of Southern California - Norris Hospital
Los Angeles, California, 90033
Coastal Clinical Research Inc
Mobile, Alabama, 36608
Tri Valley Urology Medical Group
Murrieta, California, 92562
Stanford University School of Medicine
Palo Alto, California, 94304
Beaumont Hospital
Royal Oak, Michigan, 48073
Precision Clinical Research LLC
Sunrise, Florida, 33351
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Urology of Virginia
Virginia Beach, Virginia, 23462
Bay State Clinical Trials
Watertown, Massachusetts, 02472
Iowa Clinic
West Des Moines, Iowa, 50266
About this study
Official title: 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.
- Being tested
- URO-902, Placebo
- Keywords
- URO-902, hMaxi-K, pVAX/hSlo, Overactive Bladder, Urge Urinary Incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URO-902Drug
Also called hMaxi-K, pVAX/hSlo
intradetrusor injection
PlaceboDrug
intradetrusor injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: URO-902 24 mg; Placebo | Experimental | Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo. Receives: Drug: URO-902; Drug: Placebo |
| Cohort 2: URO-902 48 mg; Placebo | Experimental | Participants will receive either a single treatment of URO-902 48 mg or matching placebo. Receives: Drug: URO-902; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and at Week 12
Secondary outcomes (1)
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.
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start16 Dec 2019
- Primary completion18 Nov 2021
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive Bladder With Urge Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanh Badger, PharmD, Study director, Urovant Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211831
- Sponsor's protocol ID
- URO-902-2001
- Status last verified
- Mar 2023
- First submitted
- 23 Dec 2019
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04211831
- Acronym / sponsor ID
- URO-902-2001
- Keywords
- URO-902, hMaxi-K, pVAX/hSlo, Overactive Bladder, Urge Urinary Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Urovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: URO-902 24 mg; Placebo | Experimental | Drug: URO-902, Drug: PlaceboParticipants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo. |
| Cohort 2: URO-902 48 mg; Placebo | Experimental | Drug: URO-902, Drug: PlaceboParticipants will receive either a single treatment of URO-902 48 mg or matching placebo. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URO-902Also: hMaxi-K, pVAX/hSlointradetrusor injection | Drug | Cohort 1: URO-902 24 mg; Placebo, Cohort 2: URO-902 48 mg; Placebo |
| Placebointradetrusor injection | Drug | Cohort 1: URO-902 24 mg; Placebo, Cohort 2: URO-902 48 mg; Placebo |
Primary outcome
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes
Time frame: Baseline (Day 1) and at Week 12
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.
1 secondary outcome
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Up to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanh Badger, PharmD study director
Urovant Sciences
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing URO-902 in people with Overactive Bladder With Urge Urinary Incontinence, run by Urovant Sciences GmbH at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes (time frame: Baseline (Day 1) and at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.