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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Be treated with mirabegron. | Active Comparator | Patients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks. |
|
| Be treated with acupuncture combined with mirabegron. | Experimental | Patients were treated with acupuncture combined with mirabegron. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 mg of mirabegron | Drug | Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaolin Deng, M.D. | Ganzhou City People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganzhou People's Hospital | Ganzhou | Jiangxi | 341000 | China |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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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.
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|
| acupuncture combined with mirabegron. | Combination Product | Patients in the treatment group were treated with acupuncture combined with mirabegron. |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |