Acupuncture Combined With Mirabegron in the Treatment of OAB

NCT06181019 | Unknown Phase 1 DMC

• 1 other identifier: TY-ZKY-2023-045-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

overactive bladder; mirabegron; acupuncture; nocturia; incontinence

Outcome Measures

Primary Outcomes (2)

• Overactive bladder syndrome scores (OABSS)

  overactive bladder syndrome scores of patient

  4, 8, and 12 weeks after treatment

• 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

Study Arms (2)

Be treated with mirabegron.

ACTIVE COMPARATOR

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

Drug: 50 mg of mirabegron

Be treated with acupuncture combined with mirabegron.

EXPERIMENTAL

Patients were treated with acupuncture combined with mirabegron.

Combination Product: acupuncture combined with mirabegron.

Interventions

50 mg of mirabegron DRUG

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

Also known as: mirabegron

Be treated with mirabegron.

acupuncture combined with mirabegron. COMBINATION_PRODUCT

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

Be treated with acupuncture combined with mirabegron.

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of OAB
• Good compliance
• Good communication skills

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Ganzhou Hospital of Nanchang University: lead

Study Sites (1)

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Nocturia

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaolin Deng, M.D.

  Ganzhou People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Senior Doctor

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 26, 2023
• Study Start: December 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CN (1)