A proof-of-concept study: mirabegron, a new therapy for overactive bladder

Neurourol Urodyn. 2013 Nov;32(8):1116-22. doi: 10.1002/nau.22373. Epub 2013 Feb 19.


Aims: To evaluate the potential of mirabegron, a selective β3-adrenoceptor agonist, for treatment of overactive bladder (OAB) symptoms.

Methods: A multicenter, randomized, double-blind, double-dummy, parallel group, placebo and active-controlled, Phase 2, proof-of-concept study was conducted. Eligible patients (n = 314) were enrolled into a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, placebo-controlled treatment period. Patients received mirabegron 100 or 150 mg twice-daily (BID), placebo or tolterodine 4 mg extended release (ER) once-daily for 4 weeks. Primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes per 24 hr. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes per 24 hr; severity of urgency; nocturia, and quality of life measures. Safety parameters included adverse events, laboratory tests, electrocardiogram parameters and post-void residual volume.

Results: Mirabegron 100 and 150 mg BID resulted in a statistically significant improvement versus placebo in mean change from baseline to end-of-treatment in the primary endpoint of micturition frequency (2.2 micturitions/24 hr vs. 1.2 micturitions/24 hr for both doses, adjusted P ≤ 0.01 for both comparisons). Mirabegron had a statistically significant effect versus placebo for most secondary endpoints, including quality of life variables. Despite a small increase in pulse rate, mirabegron demonstrated good safety and tolerability.

Conclusions: Mirabegron was efficacious and well tolerated in patients with OAB symptoms and heralds the first of a new class of oral pharmacological therapy for OAB for more than 30 years.

Trial registration: ClinicalTrials.gov NCT01604928.

Keywords: overactive bladder; phase 2 study; β3-adrenoceptor agonist.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetanilides / pharmacology
  • Acetanilides / therapeutic use*
  • Adult
  • Aged
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nocturia / drug therapy*
  • Quality of Life
  • Thiazoles / pharmacology
  • Thiazoles / therapeutic use*
  • Treatment Outcome
  • Urinary Bladder, Overactive / drug therapy*
  • Urination / drug effects*
  • Urological Agents / pharmacology
  • Urological Agents / therapeutic use*


  • Acetanilides
  • Thiazoles
  • Urological Agents
  • mirabegron

Associated data

  • ClinicalTrials.gov/NCT01604928