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

NCT ID: NCT02540707

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-08
• Study Completion Date: 2020-08-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solifenacin

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

Group Type: PLACEBO_COMPARATOR

solifenacin

Intervention Type: DRUG

solifenacin 5 mg per day for 12 weeks

Mirabegron

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

Group Type: EXPERIMENTAL

mirabegron

Intervention Type: DRUG

mirabegron 25 mg per day for 12 weeks

Interventions

solifenacin

solifenacin 5 mg per day for 12 weeks

Intervention Type: DRUG

mirabegron

mirabegron 25 mg per day for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 37160401 (View on PubMed)

Other Identifiers

201506092MIND

Identifier Type: -

Identifier Source: org_study_id