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NCT06181019 Clinical Trial

Acupuncture Combined With Mirabegron in the Treatment of OAB

Overactive Bladder Clinical Trial

— ACWMITTOOAB  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06181019
Other study ID # TY-ZKY-2023-045-01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2021
Est. completion date December 31, 2024

Study information
Verified date December 2023
Source The Affiliated Ganzhou Hospital of Nanchang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date December 31, 2024
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 14 Years to 75 Years
Eligibility 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 a-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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 50 mg of mirabegron
Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.
Combination Product:
• acupuncture combined with mirabegron.
Patients in the treatment group were treated with acupuncture combined with mirabegron.

Locations
Country Name City State
China Ganzhou People's Hospital Ganzhou Jiangxi

Sponsors (1)
Lead Sponsor Collaborator
The Affiliated Ganzhou Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overactive bladder syndrome scores (OABSS) overactive bladder syndrome scores of patient 4, 8, and 12 weeks after treatment
Primary 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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