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NCT Number: NCT02540707

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

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.

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Key information

Conditions

Overactive Bladder Syndrome

Age range

20 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Outpatient clinics, Department of Obs/Gyn, National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

solifenacin

Drug

solifenacin 5 mg per day for 12 weeks

Mirabegron

Drug

mirabegron 25 mg per day for 12 weeks

Primary outcomes

  1. Between-group difference of the effect of drug on heart rate variability

    Time frame: 12 weeks

    Between-group difference of the effect of drug on heart rate variability, such as low frequency and high frequency

  2. Between-group difference of the effect of drug on psychosomatic distress

    Time frame: 12 weeks

    Between-group difference of the effect of drug on psychosomatic distress by Brief Symptom Rating Scale

Secondary outcomes

  1. Between-group difference of the effect of drug on arterial stiffness

    Time frame: 12 weeks

    Between-group difference of the effect of drug on arterial stiffness by cardio-ankle vascular index

  2. Between-group difference of the effect of drug on clinical efficacy

    Time frame: 12 weeks

    Between-group difference of the effect of drug on clinical efficacy by Overactive Bladder Symptoms Score Questionnaire

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2015
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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