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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

Primary Purpose

Female Patients With Overactive Bladder Syndrome

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
tolterodine
mirabegron
tolterodine , mirabegron
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Patients With Overactive Bladder Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Obstetrics and Gynecology, Far Eastern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

mirabegron

tolterodine

combined therapy

Arm Description

mirabegron 25 mg

tolterodine 4 mg

tolterodine 4 mg & mirabegron 25 mg

Outcomes

Primary Outcome Measures

Improvement of overactive bladder symptoms
Change of overactive bladder symptom score between groups

Secondary Outcome Measures

Change of heart rate variability
Change of heart rate variability between groups
Change of bladder blood perfusion
Change of bladder blood perfusion between groups

Full Information

First Posted
July 7, 2023
Last Updated
September 12, 2023
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05946902
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Patients With Overactive Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mirabegron
Arm Type
Active Comparator
Arm Description
mirabegron 25 mg
Arm Title
tolterodine
Arm Type
Active Comparator
Arm Description
tolterodine 4 mg
Arm Title
combined therapy
Arm Type
Experimental
Arm Description
tolterodine 4 mg & mirabegron 25 mg
Intervention Type
Drug
Intervention Name(s)
tolterodine
Intervention Description
tolterodine 4 mg per day
Intervention Type
Drug
Intervention Name(s)
mirabegron
Intervention Description
mirabegron 25 mg per day
Intervention Type
Drug
Intervention Name(s)
tolterodine , mirabegron
Intervention Description
tolterodine 4 mg and mirabegron 25 mg per day
Primary Outcome Measure Information:
Title
Improvement of overactive bladder symptoms
Description
Change of overactive bladder symptom score between groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change of heart rate variability
Description
Change of heart rate variability between groups
Time Frame
12 weeks
Title
Change of bladder blood perfusion
Description
Change of bladder blood perfusion between groups
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change of quality of life
Description
Change of King's Health Questionnaire score between groups
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
City
Banqiao
State/Province
New Taipei
ZIP/Postal Code
22050
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Mou Hsiao, M.D.
Phone
+886-2-89667000
Ext
1818
Email
smhsiao2@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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