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

September 12, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Recruiting
        • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 weeks
Change of overactive bladder symptom score between groups
12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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