Overactive BladderPhase 4NCT05452434
Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study
A Phase 4 study testing mirabegron in people with Overactive Bladder, run by Peking Union Medical College Hospital.
Trial summary
The purpose of this study was to assess the efficacy, safety and tolerability of Mirabegron and behavioral combination versus Mirabegron alone in the treatment of women with overactive bladder (OAB）. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- mirabegron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 15 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Female aged between 40-60 years old, and no abnormalities were found in general examination, neurological examination and pelvic examination. 2. Patients with urgent urination for more than 3 months, with or without urgent incontinence, often with frequent micturition and nocturia, have normal urine routine. 3. The patients who were diagnosed as OAB by the following questionnaires, with 6≤ score ≤11 is moderate OAB, with score≥12 is severe OAB, and selected moderate and severe OAB patients. 4. Willing to join the study with signed ICF.
Who cannot join
- 1. Other diseases as obvious reasons causing OAB symptoms. 2. Patients with hypertension, of whom blood pressure is as high as 180/110 mm Hg or above. 3. Patients with gynecological malignancies, pelvic radiation therapy, stress urinary incontinence or mixed urinary incontinence with predominant stress incontinence. 4. Those taking OAB treatment drugs; 5. Pregnant (blood G-HCG determination if necessary) or lactating women; 6. Women with liver and kidney dysfunction, immunosuppressive agents, blood diseases, diabetes, mental illness or other serious diseases. 7. Poor compliance. 8. Allergic constitution, or allergic to the type of study drug
About this study
The purpose of this study was to assess the efficacy, safety and tolerability of Mirabegron and behavioral combination versus Mirabegron alone in the treatment of women with overactive bladder (OAB）.
- Conditions
- Overactive Bladder
- Being tested
- mirabegron
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
mirabegron 50mg QD for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 300 cases, mirabegron 50mg QD + behavior intervention (timed urination + left head wagging 3 times and right head wagging 3 times in urgent urination) for 12 weeks. Receives: Drug: mirabegron |
| Control group | Active comparator | 300 cases, mirabegron 50mg QD for 12 weeks Receives: Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
Measured: From first dose of study drug up to month 9
Secondary outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: From first dose of study drug up to month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Honghui Shi, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452434
- Sponsor's protocol ID
- ShiHH
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05452434
- Acronym / sponsor ID
- ShiHH
- Conditions
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the efficacy, safety and tolerability of Mirabegron and behavioral combination versus Mirabegron alone in the treatment of women with overactive bladder (OAB）.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: mirabegron300 cases, mirabegron 50mg QD + behavior intervention (timed urination + left head wagging 3 times and right head wagging 3 times in urgent urination) for 12 weeks. |
| Control group | Active comparator | Drug: mirabegron300 cases, mirabegron 50mg QD for 12 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Female aged between 40-60 years old, and no abnormalities were found in general examination, neurological examination and pelvic examination. 2. Patients with urgent urination for more than 3 months, with or without urgent incontinence, often with frequent micturition and nocturia, have normal urine routine. 3. The patients who were diagnosed as OAB by the following questionnaires, with 6≤ score ≤11 is moderate OAB, with score≥12 is severe OAB, and selected moderate and severe OAB patients. 4. Willing to join the study with signed ICF.
Key exclusion criteria (1 listed)
- 1. Other diseases as obvious reasons causing OAB symptoms. 2. Patients with hypertension, of whom blood pressure is as high as 180/110 mm Hg or above. 3. Patients with gynecological malignancies, pelvic radiation therapy, stress urinary incontinence or mixed urinary incontinence with predominant stress incontinence. 4. Those taking OAB treatment drugs; 5. Pregnant (blood G-HCG determination if necessary) or lactating women; 6. Women with liver and kidney dysfunction, immunosuppressive agents, blood diseases, diabetes, mental illness or other serious diseases. 7. Poor compliance. 8. Allergic constitution, or allergic to the type of study drug
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 |
|---|---|---|
| mirabegronmirabegron 50mg QD for 12 weeks. | Drug | Control group, Experimental group |
Primary outcome
Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
Time frame: From first dose of study drug up to month 9
1 secondary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to month 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mirabegron in people with Overactive Bladder, run by Peking Union Medical College Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 in Overactive Bladder Symptom Score (OABSS) Total Score (time frame: From first dose of study drug up to month 9). 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 11 Jul 2022.