Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study
Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05452434
Collaborator
(none)
600
2
12
Study Details
Study Description
Brief 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）.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study
Anticipated Study Start Date
:
Jul 15, 2022
Anticipated Primary Completion Date
:
Jul 15, 2023
Anticipated Study Completion Date
:
Jul 15, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group 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. |
Drug: mirabegron
mirabegron 50mg QD for 12 weeks.
|
| Active Comparator: Control group 300 cases, mirabegron 50mg QD for 12 weeks |
Drug: mirabegron
mirabegron 50mg QD for 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score [From first dose of study drug up to month 9]
Secondary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [From first dose of study drug up to month 9]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
- 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.
Exclusion Criteria:
-
- 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Honghui Shi,
Professor,
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05452434
Other Study ID Numbers:
- ShiHH
First Posted:
Jul 11, 2022
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: