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Acupuncture Combined With Mirabegron in the Treatment of OAB

NCT ID: NCT06181019

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Overactive Bladder

Keywords

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overactive bladder mirabegron acupuncture nocturia incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks, whereas patients in the treatment group were treated with acupuncture combined with mirabegron.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Be treated with mirabegron.

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

Group Type ACTIVE_COMPARATOR

50 mg of mirabegron

Intervention Type DRUG

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

Be treated with acupuncture combined with mirabegron.

Patients were treated with acupuncture combined with mirabegron.

Group Type EXPERIMENTAL

acupuncture combined with mirabegron.

Intervention Type COMBINATION_PRODUCT

Patients in the treatment group were treated with acupuncture combined with mirabegron.

Interventions

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50 mg of mirabegron

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

Intervention Type DRUG

acupuncture combined with mirabegron.

Patients in the treatment group were treated with acupuncture combined with mirabegron.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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mirabegron

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Ganzhou Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Huang Xin

Associate Senior Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaolin Deng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ganzhou People's Hospital

Locations

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Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Site Status

Countries

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China

Other Identifiers

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TY-ZKY-2023-045-01

Identifier Type: -

Identifier Source: org_study_id