Overactive Bladder
Conditions
Keywords
overactive bladder, mirabegron, acupuncture, nocturia, incontinence
Brief summary
Introduction: As conventional treatments for overactive bladder (OAB) have not yet shown satisfactory results, new approaches are needed. Therefore, this study aimed to investigate the efficacy and safety of acupuncture combined with mirabegron for the treatment of OAB. Methods: This prospective cohort study enrolled 80 OAB patients who were then divided into control and treatment groups using a randomized number-table method. The control group was administered mirabegron alone (50 mg/day), while the treatment group was administered mirabegron orally along with acupuncture at the following points: guanyuan (CV4), zhongji (CV3), and sanyinjiao (SP6). The OAB symptom score (overactive bladder syndrome score \[OABSS\]), voiding, urgency, nocturia, incontinence, and incidence of related adverse events were compared between the two groups at baseline and after 4, 8, and 12 weeks of treatment.
Interventions
DRUG50 mg of mirabegron
Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.
COMBINATION_PRODUCTacupuncture combined with mirabegron.
Patients in the treatment group were treated with acupuncture combined with mirabegron.
Sponsors
The Affiliated Ganzhou Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks, whereas patients in the treatment group were treated with acupuncture combined with mirabegron.
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of OAB * Good compliance * Good communication skills
Exclusion criteria
* Age \<14 or \>75 years * History of use of M-blockers in the recent 4-6 weeks * History of use of α-blockers in the recent 4-6 weeks * History of use of mirabegron in the recent 4-6 weeks * Diagnosis with a combined urinary tract tumor * Inability to cooperate with this study * Pregnancy * Postvoid residual urine volume \>150 mL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive bladder syndrome scores (OABSS) | 4, 8, and 12 weeks after treatment | overactive bladder syndrome scores of patient |
| voiding diary indicators (voiding, urgency, nocturia, and incontinence) | 4, 8, and 12 weeks after treatment | Number of voiding, urgency, nocturia, and incontinence in one day |
Countries
China
Outcome results
None listed