Study of higher than 80 years old patients keeping frailty under the therapy of mirabegron for overactive bladder (HOKUTO study)

Nakagomi H1, Mitsui T1, Ihara T1, Kira S1, Sawada N1, Kamiyama M1, Takeda M1

Research Type


Abstract Category

Overactive Bladder

Abstract 273
Overactive Bladder 1
Scientific Podium Short Oral Session 15
Thursday 30th August 2018
10:12 - 10:20
Hall B
Overactive Bladder Gerontology Quality of Life (QoL) Questionnaire
1. University of Yamanashi


Hypothesis / aims of study
Effective management of overactive bladder (OAB) in elderly adults is important. Mirabegron is the first b3-adrenoceptor agonist for OAB treatment. However, there are few studies in mirabegron for very elderly patients.‘‘Frail’’ is defined as a state of vulnerability associated with impaired physical activity, mobility, cognition, nutrition, and endurance(1). The risk of adverse drug reactions  increases with increasing patient frailty(2). Here we assessed not only  the efficacy and safety but also impact to fraility of mirabegron in very elderly adults (≥ 80 years old) with OAB but also .
Study design, materials and methods
This prospective, single-arm observational study included patients aged ≥80 years with OAB, as determined by an OAB symptom score (OABSS) total of ≥3 points and an OABSS Question 3 score of ≥2 points. Patients received 50mg mirabegron once daily were evaluated at baseline, 4, 8, and 12 weeks via efficacy endpoints were changes from baseline in OABSS, IPSS, OAB questionnaire (OAB-q), VES-13 (Vulnerable Elders Survey), the Kihon Checklist score. Safety assessments included adverse events (AEs), laboratory tests, 12-lead electrocardiogram, QT corrected for heart rate using Fridericia’s correction (QTcF) interval, Uroflowmetry, post-void residual(PVR) volume and MMSE (Mini-Mental State Examination).
A total of 43 patients (80-96 years old, mean 85 years old) were examined. Subjects had high rates of comorbidities and polypharmacy (Table1). OAB symptom scores improved, with significant changes in urgency, incontinence, and total symptom scores (Fig.1). IPSS total, IPSS storage symptom score, QOL index, and the score of OAB-q (symptom bother, Total HRQL, Concern, and Coping) was significantly improved. Mirabegron showed the significant improvement in the score of VES-13 excluding the item of age. There was no significant change in the Kihon Checklist, laboratory tests, QTcF, Uroflowmetry, PVR volume and MMSE. Two participants (4.7%) discontinued the study for adverse events.
Interpretation of results
A β3-adrenoceptors agonist, mirabegron, is efficacious and generally well tolerated treatment for OAB in very old population.These results provide important evidence that medically complex elderly individuals with OAB benefit significantly and broadly, such as improving in frail, from treatment with mirabegron
Concluding message
Mirabegron significantly improved OAB symptoms, QOL score, frailty and was generally well tolerated in very elderly patients.
Figure 1
Figure 2
  1. Wynne H, The association of age and frailty with paracetamol conjugation in man. Age Ageing 1990; 19: 419–24.
  2. Ruth E. Hubbard, Medication prescribing in frail older people.European Journal of Clinical Pharmacology March 2013, 6: 3, 319–326
Funding None Clinical Trial No Subjects Human Ethics Committee The ethics committee of the University of Yamanashi Helsinki Yes Informed Consent Yes