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
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

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