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

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.

Study Overview

• Status: Recruiting
• Conditions: Female Patients With Overactive Bladder Syndrome
• Intervention / Treatment: Drug: mirabegron; Drug: tolterodine; Drug: tolterodine , mirabegron

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei
    • Banqiao, New Taipei, Taiwan, 22050
      • Recruiting
      • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
      • Contact: Sheng-Mou Hsiao, M.D.; Phone Number: 1818 +886-2-89667000; Email: smhsiao2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: mirabegron; mirabegron 25 mg	Drug: mirabegron; mirabegron 25 mg per day
Active Comparator: tolterodine; tolterodine 4 mg	Drug: tolterodine; tolterodine 4 mg per day
Experimental: combined therapy; tolterodine 4 mg & mirabegron 25 mg	Drug: tolterodine , mirabegron; tolterodine 4 mg and mirabegron 25 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of overactive bladder symptoms	Change of overactive bladder symptom score between groups	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of heart rate variability	Change of heart rate variability between groups	12 weeks
Change of bladder blood perfusion	Change of bladder blood perfusion between groups	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of quality of life	Change of King's Health Questionnaire score between groups	12 weeks

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron; Tolterodine Tartrate
• Other Study ID Numbers: 112019-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No