Comparative study of therapeutic efficacy and safety between mirabegron 50mg QD and solifenacin 5mg QD in patients with overactive bladder due to central nervous system diseases such as cerebral vascular accident, Parkinson’s disease, and dementia – A multicenter, randomized study

Liao C1, Chen S2, Lee C2, Jhang J2, Jiang Y2, Kuo H2

Research Type


Abstract Category


Abstract 36
ePoster 1
Scientific Open Discussion ePoster Session 4
Thursday 19th November 2020
10:35 - 10:40 (ePoster Station 2)
Exhibition Hall
Pharmacology Incontinence Neuropathies: Central
1. Department of Urology, Cardinal Tien Hospital and School of Medicine, Fu-Jen Catholic University, New Taipei, Taiwan, 2. Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and Tzu Chi University, Hualien, Taiwan

Chun-Hou Liao



Hypothesis / aims of study
Central nerve system (CNS) disease, such as cerebrovascular accident (CVA), white matter disease like parkinsonism or Parkinson’s disease (PD) and dementia are common chronic ischemic brain diseases in the elderly, were associated with higher incidence of overactive bladder (OAB). Treatment with antimuscarinics or mirabegron is the mainstay treatment for OAB. However, there has been no consensus which medication is favorable. The objective of this study is to evaluate and compare the therapeutic efficacy and adverse events between mirabegron 50 mg QD, solifenacin 5 mg QD, and combined solifenacin 5 mg and mirabegron 50 mg QD, in patients with OAB due to CNS diseases such as CVA, PD, and early dementia.
Study design, materials and methods
Patients aged over 40 years old with OAB symptoms and previous history of CVA, PD or dementia were enrolled. Patients were medicated with tamsulosin 0.4 mg QD for two weeks without adding any OAB medication (wash out period). Then they were randomized to one of the three subgroups and received (A) solifenacin 5 mg QD, (B) mirabegron 50 mg QD, and (C) combined solifenacin 5 mg and mirabegron 50 mg QD. Efficacy and safety parameters such as overactive bladder symptom score (OABSS), urgency severity score (USS), international prostate symptom score (IPSS) and subscore, maximum flow rate (Qmax), voided volume, postvoid residual (PVR) volume, and void efficiency (VE) were compared between baseline and 3 months after treatment.
Of the 67 patients (mean age, 73.0 years) enrolled, 24 received mirabegron monotherapy, 25 received solifenacin monotherapy, and 18 received combination therapy. The baseline characteristics and urodynamic parameters were similar among groups. OAB symptoms improved in both mirabegron and solifenacin treatment. There was no significant difference of symptom score changes among 3 groups. However, there was significant increased of PVR and decreased of VE in combination group. Most adverse events (AEs) were mild. Dry mouth was complained in 6 patients (24%) in the solifenacin group and 5 patients (27.8%) in the combination group. Constipation was noted in 2 patients (8%) in the solifenacin group while dysuria was complained in 5 patients (273.8%) in the combination group.
Interpretation of results
In previous clinical trial, combined mirabegron and solifenacin was well tolerated. However, combination therapy resulted in increased PVR and higher AEs rate in patients with CNS disease. In addition, the improvement of symptoms was also not superior to monotherapy. It seems mirabegron monotherapy is more preferable as first -line treatment for patients with CNS disease.
Concluding message
Both mirabegron and solifenacin can improve OAB symptoms. Patients receiving mirabegron had less AEs than those receiving solifenacin and combination treatment. Patients receiving combination treatment had higher PVR and lower VE than monotherapy.
Figure 1 Table 1. Baseline characteristics
Figure 2 Table 2. Comparisons of parameters between baseline and 3 months after treatment
Funding Astellas Clinical Trial Yes Public Registry No RCT Yes Subjects Human Ethics Committee Research Ethics Committee, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Helsinki Yes Informed Consent Yes