Patient-reported outcomes with the β 3 -adrenoceptor agonist mirabegron in a phase III trial in patients with overactive bladder

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


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

Methods: 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.

Results: 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.

Conclusions: 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.

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

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Absenteeism
  • Acetanilides / therapeutic use*
  • Adrenergic beta-3 Receptor Agonists / therapeutic use*
  • Aged
  • Double-Blind Method
  • Female
  • Humans
  • Incontinence Pads / statistics & numerical data
  • Male
  • Middle Aged
  • Muscarinic Antagonists / therapeutic use
  • Patient Reported Outcome Measures
  • Quality of Life
  • Thiazoles / therapeutic use*
  • Tolterodine Tartrate / therapeutic use
  • Treatment Outcome
  • Urinary Bladder, Overactive / complications
  • Urinary Bladder, Overactive / drug therapy*
  • Urinary Bladder, Overactive / psychology


  • Acetanilides
  • Adrenergic beta-3 Receptor Agonists
  • Muscarinic Antagonists
  • Thiazoles
  • Tolterodine Tartrate
  • mirabegron