Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

Phase 4

Recruiting

• Conditions: Female Patients With Overactive Bladder Syndrome
• Interventions: Drug: mirabegron; Drug: tolterodine; Drug: tolterodine , mirabegron

• Registration Number: NCT05946902
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

To evaluate the impact of combined therapy on the heart rate variability, compared with monotherapy in women with overactive bladder syndrome. Secondary objective is to evaluate the impact of combined therapy on bladder blood perfusion.

Detailed Description

Patients and methods:

We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital, and will recruit 150 female patients with overactive bladder syndrome. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the urgency severity score, the overactive bladder symptom score questionnaire, and the King's health questionnaire before taking the drug and four weeks and twelve weeks after taking the drug. In addition, measurement of heart rate variability and bladder blood perfusion will be performed.

Expected results:

We will obtain the impact of monotherapy with tolterodine or mirabegron versus combined therapy on heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.

Study Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-14
• Status Verified: 2023-09
• Study Start: 2023-09-12
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• >20 years old .
• female patients with overactive bladder syndrome

Exclusion Criteria

• Cases of hypersensitivity to mirabegron or tolterodine.
• Betanley is contraindicated in the following patients: uncontrolled severe hypertension.
• Dexotol is contraindicated in the following patients: known urethral diverticulum, known bladder malignancy, patients with urinary retention and gastric retention, patients with uncontrolled narrow-angle glaucoma, patients with renal dialysis, severe renal dysfunction (ie Inulin clearance rate (GFR<30 ml/min) or liver dysfunction (i.e. liver cirrhosis), use strong CYP3A4 inhibitors such as ketoconazole.
• Patients with myasthenia gravis.
• The patient is taking drugs that interact with tolterodine or mirabegron.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mirabegron	mirabegron	mirabegron 25 mg
tolterodine	tolterodine	tolterodine 4 mg
combined therapy	tolterodine , mirabegron	tolterodine 4 mg \& mirabegron 25 mg

Primary Outcome Measures

Name	Time	Method
Improvement of overactive bladder symptoms	12 weeks	Change of overactive bladder symptom score between groups

Secondary Outcome Measures

Name	Time	Method
Change of heart rate variability	12 weeks	Change of heart rate variability between groups
Change of bladder blood perfusion	12 weeks	Change of bladder blood perfusion between groups

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan