Acupuncture Combined With Mirabegron in the Treatment of Overactive Bladder Syndrome: A Prospective Randomized Controlled Trial
Overview
- Phase
- Phase 1
- Intervention
- 50 mg of mirabegron
- Conditions
- Overactive Bladder
- Sponsor
- The Affiliated Ganzhou Hospital of Nanchang University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Overactive bladder syndrome scores (OABSS)
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Huang Xin
Associate Senior Doctor
The Affiliated Ganzhou Hospital of Nanchang University
Eligibility Criteria
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
Arms & Interventions
Be treated with mirabegron.
Patients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.
Intervention: 50 mg of mirabegron
Be treated with acupuncture combined with mirabegron.
Patients were treated with acupuncture combined with mirabegron.
Intervention: acupuncture combined with mirabegron.
Outcomes
Primary Outcomes
Overactive bladder syndrome scores (OABSS)
Time Frame: 4, 8, and 12 weeks after treatment
overactive bladder syndrome scores of patient
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