Acupuncture Combined With Mirabegron in the Treatment of OAB

Phase 1

Active, not recruiting

• Conditions: Overactive Bladder
• Interventions: Combination Product: acupuncture combined with mirabegron.; Drug: 50 mg of mirabegron

• Registration Number: NCT06181019
• Lead Sponsor: The Affiliated Ganzhou Hospital of Nanchang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-03-31
• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Be treated with acupuncture combined with mirabegron.	acupuncture combined with mirabegron.	Patients were treated with acupuncture combined with mirabegron.
Be treated with mirabegron.	50 mg of mirabegron	Patients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ganzhou People's Hospital; 🇨🇳 Ganzhou, Jiangxi, China