Back to resultsPharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin
Primary Purpose
Overactive Bladder Syndrome
Status
Recruiting
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Mirabegron
Solifenacin
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility Criteria
Inclusion Criteria:
- Overactive bladder syndrome
Exclusion Criteria:
- Allergy to mirabegron or solifenacin.
- Patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of CYP3A4 such as ketoconazole.
Sites / Locations
- Department of Obstetrics and Gynecology, Far-Eastern Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
mirabegron
solifenacin
Arm Description
Receive mirabegron 2 mg treatment per day
Receive solifenacin 5 mg treatment per day
Outcomes
Primary Outcome Measures
Global response assessment
Between-group difference in the score of Global response assessment
Secondary Outcome Measures
Total score of Brief Symptoms Rating Scales
Between-group difference in the changes of total score of Brief Symptoms Rating Scales
Female sexual function index
Between-group difference in the changes of total score of female sexual function index
Bladder wall thickness
Between-group difference in the changes of bladder wall thickness
Blood flow index of the bladder
Between-group difference in the changes of blood flow index of the bladder
Full Information
NCT ID
NCT04023253
First Posted
July 12, 2019
Last Updated
September 14, 2023
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04023253
Brief Title
Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin
Official Title
Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood 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
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 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 assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and bladder blood flow.
Detailed Description
To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and blood flow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mirabegron
Arm Type
Experimental
Arm Description
Receive mirabegron 2 mg treatment per day
Arm Title
solifenacin
Arm Type
Experimental
Arm Description
Receive solifenacin 5 mg treatment per day
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Intervention Description
Mirabegron 25 mg
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Intervention Description
Solifenacin 5 mg
Primary Outcome Measure Information:
Title
Global response assessment
Description
Between-group difference in the score of Global response assessment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total score of Brief Symptoms Rating Scales
Description
Between-group difference in the changes of total score of Brief Symptoms Rating Scales
Time Frame
12 weeks
Title
Female sexual function index
Description
Between-group difference in the changes of total score of female sexual function index
Time Frame
12 weeks
Title
Bladder wall thickness
Description
Between-group difference in the changes of bladder wall thickness
Time Frame
12 weeks
Title
Blood flow index of the bladder
Description
Between-group difference in the changes of blood flow index of the bladder
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Overactive bladder syndrome
Exclusion Criteria:
Allergy to mirabegron or solifenacin.
Patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of CYP3A4 such as ketoconazole.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Mou Hsiao, MD
Phone
+886289667000
Ext
1818
Email
smhsiao2@gmail.com
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
Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin
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