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

December 21, 2023 updated by: Huang Xin, The Affiliated Ganzhou Hospital of Nanchang University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Ganzhou People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Be treated with mirabegron.
Patients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.
Drug: 50 mg of mirabegron
Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.
Other Names:
  • mirabegron
Experimental: Be treated with acupuncture combined with mirabegron.
Patients were treated with acupuncture combined with mirabegron.
Combination product: acupuncture combined with mirabegron.
Patients in the treatment group were treated with acupuncture combined with mirabegron.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive bladder syndrome scores (OABSS)
Time Frame: 4, 8, and 12 weeks after treatment
overactive bladder syndrome scores of patient
4, 8, and 12 weeks after treatment
voiding diary indicators (voiding, urgency, nocturia, and incontinence)
Time Frame: 4, 8, and 12 weeks after treatment
Number of voiding, urgency, nocturia, and incontinence in one day
4, 8, and 12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Ganzhou Hospital of Nanchang University

Investigators

  • Principal Investigator: Xiaolin Deng, M.D., Ganzhou People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TY-ZKY-2023-045-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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