RESULTS
Salient demographic patient pre- and post-treatment parameters are
depicted in Table 1(a) and 1(b) respectively, the pre-treatment data was
comparable in most parameters with the exception of nocturia
(p<0.001) and IPSS (SS), p = 0.001. In terms of the post
treatment data (Table 1b) that there was statistically significant
improvement of the OABS score (primary outcome parameter) in the
intervention group (Mean difference -5.62 vs -2.22p< 0.001).
Similar improvements were seen in most secondary outcome parameters
[mean change in voiding episode/night, IPSS, IPSS-S, OABS-SS, voided
volume/micturition, Qmax and QOL (p<0.001)]. As opposed to
other published studies depicting acute urinary retention (AUR) as a
major complication of Mirabegron intake, our study did not reveal any
significant increase in PVR (p=0.136) nor any Acute Urinary Retention
(AUR)in the intervention arm.Three of 80(3.8%), 2 and 1 in groups I and
II respectively) had TEAE (tachycardia/headache) which were minor
self-limiting and managed symptomatically without drug discontinuity.
There was complete compliance to the administered therapy.