Overview

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

Status:
Unknown status

Trial end date:
2016-09-01

Target enrollment:
0

Participant gender:
Female

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Taiwan University Hospital

Treatments:

Mirabegron
Solifenacin Succinate

Criteria

Inclusion Criteria:

- Women with overactive bladder syndrome

- ≥20 year-old

Exclusion Criteria:

- Urine retention,

- acute angle glaucoma,

- myasthenia gravis,

- ulcerative colitis,

- megacolon