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

Overactive Bladder Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540707
• Other study ID #: 201506092MIND
• Status: Completed
• Phase: Phase 4
• Start date: September 8, 2015
• Est. completion date: August 26, 2020

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• Women with overactive bladder syndrome

• =20 year-old

Exclusion Criteria:

• Urine retention,

• acute angle glaucoma,

• myasthenia gravis,

• ulcerative colitis,

• megacolon

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin
solifenacin 5 mg per day for 12 weeks
• mirabegron
mirabegron 25 mg per day for 12 weeks

Locations

Country	Name	City	State
Taiwan	Outpatient clinics, Department of Obs/Gyn, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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