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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02540707

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Syndrome	Drug: solifenacin Drug: mirabegron	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Solifenacin

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

Drug: solifenacin

solifenacin 5 mg per day for 12 weeks

Experimental: Mirabegron

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

Drug: mirabegron

mirabegron 25 mg per day for 12 weeks

Outcome Measures

Primary Outcome Measures

Between-group difference of the effect of drug on heart rate variability [12 weeks]
Between-group difference of the effect of drug on heart rate variability, such as low frequency and high frequency
Between-group difference of the effect of drug on psychosomatic distress [12 weeks]
Between-group difference of the effect of drug on psychosomatic distress by Brief Symptom Rating Scale

Secondary Outcome Measures

Between-group difference of the effect of drug on arterial stiffness [12 weeks]
Between-group difference of the effect of drug on arterial stiffness by cardio-ankle vascular index
Between-group difference of the effect of drug on clinical efficacy [12 weeks]
Between-group difference of the effect of drug on clinical efficacy by Overactive Bladder Symptoms Score Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with overactive bladder syndrome
≥20 year-old

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Outpatient clinics, Department of Obs/Gyn, National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT02540707

Other Study ID Numbers:

201506092MIND

First Posted:

Sep 4, 2015

Last Update Posted:

Apr 12, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Solifenacin Succinate

Mirabegron

Study Results

No Results Posted as of Apr 12, 2016