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.
Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin
Sponsors
Source
Far Eastern Memorial Hospital
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Recruiting
Start Date
2019-08-01
Completion Date
2022-12-31
Primary Completion Date
2022-12-31
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Global response assessment |
12 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Total score of Brief Symptoms Rating Scales |
12 weeks |
|
Female sexual function index |
12 weeks |
|
Bladder wall thickness |
12 weeks |
|
Blood flow index of the bladder |
12 weeks |
Enrollment
120
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Mirabegron 25 mg
Arm Group Label
mirabegron
Intervention Type
Drug
Intervention Name
Description
Solifenacin 5 mg
Arm Group Label
solifenacin
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.
Gender
Female
Minimum Age
20 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Contact
Location
Facility |
Status |
Contact |
|
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital Banqiao New Taipei 22050 Taiwan |
Recruiting |
Location Countries
Country
Taiwan
Verification Date
2019-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Far Eastern Memorial Hospital
Investigator Full Name
Sheng-Mou Hsiao
Investigator Title
Chief and Associate Professor, Department of Obstetrics and Gynecology
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Solifenacin Succinate
Mirabegron
Arm Group
Arm Group Label
mirabegron
Arm Group Type
Experimental
Description
Receive mirabegron 2 mg treatment per day
Arm Group Label
solifenacin
Arm Group Type
Experimental
Description
Receive solifenacin 5 mg treatment per day
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
July 12, 2019
Study First Submitted Qc
July 15, 2019
Study First Posted
July 17, 2019
Last Update Submitted
October 19, 2019
Last Update Submitted Qc
October 19, 2019
Last Update Posted
October 22, 2019
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.