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

NCT02540707 | Completed Phase 4 DMC

• 1 other identifier: 201506092MIND
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Between-group difference of the effect of drug on arterial stiffness

  12 weeks

• Between-group difference of the effect of drug on clinical efficacy

  12 weeks

Study Arms (2)

Solifenacin

PLACEBO COMPARATOR

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

Drug: solifenacin

Mirabegron

EXPERIMENTAL

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

Drug: mirabegron

Interventions

solifenacin DRUG

solifenacin 5 mg per day for 12 weeks

Solifenacin

mirabegron DRUG

mirabegron 25 mg per day for 12 weeks

Mirabegron

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, 100, Taiwan

Location

Related Publications (1)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

MeSH Terms

Interventions

Solifenacin Succinate; mirabegron

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 4, 2015
• Study Start: September 8, 2015
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

TW (1)