Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female population. Antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic distress. However, there is no such research for the new drug- mirabegron (a β3-agonist). Thus, the aim of our study is to analyze the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups. Patients and Methods: The investigators will perform a prospective randomized controlled study to recruit 150 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of National Taiwan University Hospital. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, UDI-6 & IIQ-7, Patient Health Questionnaire, brief symptom rating scale (BSRS), Maudsley personality inventory (MPI) and adaptability, partnership, growth, affection, and resolve (APGAR) questionnaires, Sleep and Dietary habit Questionnaire, standard 12-leads electrocardiography (ECG), 5 minutes Holter monitoring, cardio-ankle vascular index (CAVI) test, bladder diary, 20-min pad test, urodynamic studies and measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron versus solifenacin treatment. STATA software is used for statistical analyses. Possible Results: The investigators can answer that the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups. The above conclusions should be important for pre-treatment consultation.

Official Title
-----------------
Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes: A Prospective Randomized Controlled Trial

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Drug: solifenacin
* Drug: mirabegron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with overactive bladder syndrome ≥20 year-old Exclusion Criteria: Urine retention, acute angle glaucoma, myasthenia gravis, ulcerative colitis, megacolon

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Solifenacin<br>Women with overactive bladder syndrome will be treated by solifenacin 5 mg qd * 12 weeks | Drug: solifenacin<br>* solifenacin 5 mg per day for 12 weeks<br>|
| Experimental: Mirabegron<br>Women with overactive bladder syndrome will be treated by mirabegron 25 mg qd * 12 weeks | Drug: mirabegron<br>* mirabegron 25 mg per day for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference of the effect of drug on heart rate variability | Between-group difference of the effect of drug on heart rate variability, such as low frequency and high frequency | 12 weeks | 
| Between-group difference of the effect of drug on psychosomatic distress | Between-group difference of the effect of drug on psychosomatic distress by Brief Symptom Rating Scale | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference of the effect of drug on arterial stiffness | Between-group difference of the effect of drug on arterial stiffness by cardio-ankle vascular index | 12 weeks | 
| Between-group difference of the effect of drug on clinical efficacy | Between-group difference of the effect of drug on clinical efficacy by Overactive Bladder Symptoms Score Questionnaire | 12 weeks |