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Neurourol Urodyn. 2016 Nov;35(8):987-994. doi: 10.1002/nau.22844. Epub 2015 Aug 19.

Patient-reported outcomes with the β3 -adrenoceptor agonist mirabegron in a phase III trial in patients with overactive bladder.

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Urogynaecology Department, St Mary's Hospital, Imperial College, London, United Kingdom.
Department of Neuro-Urology, Sorbonne Universités, GREEN Group of Clinical Research in Neuro-Urology, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.
Department of Urology, Hospital Universitario de Getafe, Universidad Europea de Madrid, Madrid, Spain.
Astellas Pharma Global Development, Inc, Biostatistics, Northbrook, Illinois.
Astellas Pharma Europe Ltd, Chertsey, United Kingdom.
Astellas Pharma Global Development EU, Leiden, the Netherlands.



To assess patient-reported outcomes (PROs) in patients with overactive bladder (OAB) receiving the novel β3 -adrenoceptor agonist mirabegron.


Data from a randomised, double-blind, controlled phase III trial in 1,987 patients aged ≥18 years with OAB symptoms for ≥3 months were analysed. Patients received placebo, mirabegron 50 or 100 mg/day, or tolterodine extended release (ER) 4 mg orally once daily for 12 weeks after a 2-week placebo run-in. Prespecified analysis of PROs (changes in OAB Questionnaire [OAB-q], Patient Perception of Bladder Condition [PPBC], and Work Productivity and Activity Impairment: Specific Health Problem [WPAI-SHP] instrument) in patients treated with mirabegron 50 mg/day, tolterodine ER 4 mg/day or placebo is reported. Post-hoc analyses of OAB-q, PPBC and the Treatment Satisfaction-Visual Analogue Scale (TS-VAS) in patients who were incontinent at baseline are also reported.


Significant improvements over placebo in OAB-q coping and concern from baseline to final visit were observed with mirabegron 50 mg/day. No significant improvements in these parameters were observed with tolterodine ER 4 mg/day. Mirabegron 50 mg/day significantly increased the proportion of patients showing a PPBC improvement over placebo. Mirabegron 50 mg/day also produced greater improvements in WPAI-SHP presenteeism and greater reductions in absenteeism and overall work impairment than placebo or tolterodine ER 4 mg/day. The impact of mirabegron 50 mg/day treatment on PROs in the incontinent population appears to be greater than that in the overall OAB population.


At the approved dose of 50 mg/day, mirabegron significantly improves OAB patients' perception of disease and quality of life, independent of whether they are incontinent at baseline. Neurourol. Urodynam. 35:987-994, 2016. © 2015 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.


overactive bladder (OAB); patient outcome assessment; quality of life; β3-adrenoceptor agonist

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