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

National Taiwan University

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder Syndrome

Treatments: Drug: mirabegron; Drug: solifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02540707

201506092MIND

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: Female

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with overactive bladder syndrome
• ≥20 year-old

Exclusion criteria

• Urine retention,
• acute angle glaucoma,
• myasthenia gravis,
• ulcerative colitis,
• megacolon

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups, including a placebo group

Solifenacin

Placebo Comparator group

Description:

Women with overactive bladder syndrome will be treated by solifenacin 5 mg qd \* 12 weeks

Treatment:

Drug: solifenacin

Mirabegron

Experimental group

Description:

Women with overactive bladder syndrome will be treated by mirabegron 25 mg qd \* 12 weeks

Treatment:

Drug: mirabegron