MATERIALS AND METHODS
A prospective randomised control study was performed on 80 eligible and
consenting patients of BPH with predominantly OABS with the primary
intent to treat, as per protocol inclusion criteria (newly diagnosed
uncomplicated BPH of any size with predominant OABS and an IPSS
>7 without any medical contraindications to the planned
drug therapy or any absolute indication for surgery). Patients with
prior history of anaphylaxis/hypersensitivity, drug therapy with
metabolic interference to administered medication, prostatic/urethral
surgery andother concomitant prostate diseases or neurogenic bladder
were excluded from this study. Patients were computer randomised and
allocated to either the intervention group (I) (Tamsulosin 0.4 mg plus
50mg Mirabegron tablet) or the comparator group (II) (Tamsulosin 0.4 mg
plus capsule lactobacillus 1 capsules) with the medications administered
at bedtime after meals for study period of two months (considering rapid
onset of action of drugs in both the arms and their major side effects
if any would be exhibited within this study time frame). Patients were
evaluated as per protocol with (hemogram, LFT, KFT and urine routine,
culture, ECG, ultrasound KUB+PVR and uroflow) during the initial visit
(D0) prior to initiation of therapy. The efficacy outcome measure was
evaluated by estimating the OABSS(primary outcome parameter)followed by
the mean change nocturnal voiding frequency, PVR and IPSS (secondary
efficacy parameters).Safety was assessed by monitoring for post therapy
TEAE with follow up visits at the 2nd,
4th and 8th week post initiation of
therapy. Fig-1 depicts flow of the current study protocol.
Statistical Analysis: Statistical analysis was performed
using Statistical Package for the Social Sciences version 23.0 IBM™, New
York, USA. The data was recorded in the MS Excel worksheet. Continuous
data was analysed by unpaired Student’s t test while the
Chi-square test and Repeated measure ANOVA was used to analyse the
categorical data. P < .05 was considered statistically
significant.
Power factor &sample size calculation: Based on a
similar published comparative study by Ichihara et
al7 in which 94 patients were randomised (76
completed the study) considering a standard deviation (SD) in the peak
flow rate of 12.33 ± 1.22 in tamsulosin group and 10.5 ± 1.79 in the
Mirabegron group with Power = 90% and α = 5% hence, to estimate this
difference in mean value, the requisite sample size for significance was
about 20 per group. We incorporated a study sample size of 80 (40
subjects in each group).