Back to resultsMirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing
Primary Purpose
Overactive Bladder Syndrome
Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
daytime dosing of mirabegron
nighttime dosing of mirabegron
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility Criteria
Inclusion Criteria:
- OAB symptoms for at least one month
- >20 years
Exclusion Criteria:
- Allergy to mirabegron, urinary tract infections, unstable hypertension
Sites / Locations
- Far Eastern Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A
group B
Arm Description
daytime dosing of mirabegron
nighttime dosing of mirabegron
Outcomes
Primary Outcome Measures
Nocturia episodes
comparison of baseline and post-treatment nocturia episodes from bladder diary
Secondary Outcome Measures
Severity of nocturia
comparison of baseline and post-treatment severity of nocturia from questionnaires
Full Information
NCT ID
NCT03251300
First Posted
August 10, 2017
Last Updated
March 27, 2023
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03251300
Brief Title
Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing
Official Title
Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2017 (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
5. Study Description
Brief Summary
The aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.
Detailed Description
Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to elucidate whether night-time dosing can improve nocturia, compared with daytime dosing.
Patients and Methods: The investigators will perform a prospective randomized controlled trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron. All enrolled OAB women will be allocated to two groups (group A and B). The women in group A will receive daytime dosing of mirabegron treatment; and the women in group B will receive nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron treatment. STATA software is used for statistical analyses.
Possible Results: The investigators can answer whether night-time dosing of mirabegron can improve nocturia, compared with daytime dosing.
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 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
daytime dosing of mirabegron
Arm Title
group B
Arm Type
Active Comparator
Arm Description
nighttime dosing of mirabegron
Intervention Type
Drug
Intervention Name(s)
daytime dosing of mirabegron
Intervention Description
All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron
Intervention Type
Drug
Intervention Name(s)
nighttime dosing of mirabegron
Intervention Description
All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron
Primary Outcome Measure Information:
Title
Nocturia episodes
Description
comparison of baseline and post-treatment nocturia episodes from bladder diary
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Severity of nocturia
Description
comparison of baseline and post-treatment severity of nocturia from questionnaires
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OAB symptoms for at least one month
>20 years
Exclusion Criteria:
Allergy to mirabegron, urinary tract infections, unstable hypertension
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
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
1424
Email
smhsiao2@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
28714288
Citation
Tsai KH, Hsiao SM, Lin HH. Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia. J Obstet Gynaecol Res. 2017 Nov;43(11):1719-1725. doi: 10.1111/jog.13438. Epub 2017 Jul 16.
Results Reference
result
Learn more about this trial
Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing
We'll reach out to this number within 24 hrs