Acupuncture Combined With Mirabegron in the Treatment of OAB (ACWMITTOOAB)

The Affiliated Ganzhou Hospital of Nanchang University

Status and phase: Active, not recruiting; Phase 1

Conditions: Overactive Bladder

Treatments: Drug: 50 mg of mirabegron; Combination Product: acupuncture combined with mirabegron.

Study type: Interventional

Funder types: Other

Identifiers

NCT06181019

TY-ZKY-2023-045-01

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

Be treated with mirabegron.

Active Comparator group

Description:

Patients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.

Treatment:

Drug: 50 mg of mirabegron

Be treated with acupuncture combined with mirabegron.

Experimental group

Description:

Patients were treated with acupuncture combined with mirabegron.

Treatment:

Combination Product: acupuncture combined with mirabegron.