Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study

Phase 4

• Conditions: Overactive Bladder
• Interventions: Drug: mirabegron

• Registration Number: NCT05452434
• Lead Sponsor: Peking Union Medical College Hospital

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）.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Last Update Submitted: 2022-07-06
• Study First Posted: 2022-07-11
• Last Update Posted: 2022-07-11
• Study Start: 2022-07-15
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	mirabegron	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.
Control group	mirabegron	300 cases, mirabegron 50mg QD for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	From first dose of study drug up to month 9

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of study drug up to month 9