Overactive Bladder
Conditions
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）.
Interventions
DRUGmirabegron
mirabegron 50mg QD for 12 weeks.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score | From first dose of study drug up to month 9 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to month 9 |
Outcome results
None listed