Acupuncture Combined With Mirabegron in the Treatment of OAB

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture Combined With Mirabegron in the Treatment of Overactive Bladder Syndrome: A Prospective Randomized Controlled Trial

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: 50 mg of mirabegron
* Combination Product: acupuncture combined with mirabegron.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Be treated with mirabegron.<br>Patients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks. | Drug: 50 mg of mirabegron<br>* Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.<br>* Other names: mirabegron;|
| Experimental: Be treated with acupuncture combined with mirabegron.<br>Patients were treated with acupuncture combined with mirabegron. | Combination Product: acupuncture combined with mirabegron.<br>* Patients in the treatment group were treated with acupuncture combined with mirabegron.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder syndrome scores (OABSS) | overactive bladder syndrome scores of patient | 4, 8, and 12 weeks after treatment | 
| voiding diary indicators (voiding, urgency, nocturia, and incontinence) | Number of voiding, urgency, nocturia, and incontinence in one day | 4, 8, and 12 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, mirabegron, acupuncture, nocturia, incontinence