TABLE 1b POST TREATMENT DATA COMPARISON BETWEEN GROUPS
PARAMETERS
GROUP I MIRABEGRON + TAMSULOSIN GROUP I MIRABEGRON + TAMSULOSIN GROUP II TAMSULOSIN + PLACEBO GROUP II TAMSULOSIN + PLACEBO GROUP II TAMSULOSIN + PLACEBO
Efficacy parameters Mean ±SD Mean Change FB Mean ±SD Mean change FB P-value
Total OABSS Baseline Endpoint 7.95±2.80 2.33±1.82
-5.68±1.85
6.75±2.08 4.53±1.88
-2.23±1.59
<0.001
Day frequency Baseline Endpoint 1±0.64 0.08±0.27
-0.92±0.68
0.80±0.65 0.10±0.30
-0.70±0.56
0.103
Nocturia Baseline Endpoint 2.95±0.50 0.75±0.67
-2.20±0.65
2.73±0.45 2.02±o.73
-0.70±0.56
<0.001
Urgency Baseline Endpoint 3.05±1.52 1.07±0.94
-1.98±1.14
2.80±1.47 1.88±1.16
-0.92±1.12
<0.001
Urge incontinence Baseline Endpoint 1.10±1.46 0.40±0.74
-0.70±1.04
0.42±0.98 0.32±0.73
-0.10±0.38
<0.001
Nocturia frequency Baseline Endpoint 5.75±2.03 0.70±0.69
-5.05±1.78
3.90±1.35 2.33±1.29
-1.57±1.38
<0.001
Total IPSS Baseline Endpoint 18.45±6.12 5.72±3.46
-12.72±4.19
16.55±6.19 9.07±3.81
-7.47±4.27
<0.001
IPSS-V Baseline Endpoint 5.85±5.09 2.48±2.84
-3.40±3.12
5.88±4.81 2.88±2.90
-3.00±3.08
0.752
IPSS-S Baseline Endpoint 12.68±2.71 3.27±1.26
-9.40±2.57
10.97±3.02 6.38±2.16
-4.60±2.35
<0.001
Qmax Baseline Endpoint 7.94±4.03 11.98±3.98
4.04±4.35
10.03±8.03 10.75±7.02
0.72±3,51
<0.001
VV Baseline Endpoint 236.90±120.12 366.30±164.29
129.40±149.24
249.40±114.03 336.32±323.64
86.92±288.99
<0.001
PVR Baseline Endpoint 58.38±68.79 51.17±51.32
-7.20±42.66
79.35±119.39 49.08±70.07
-30.27±89.62
0.136
QOL index Baseline Endpoint 4.88±0.52 1.82±0.55
-3.05±0.55
5.03±0.92 2.65±0.95
-2.38±1.00
<0.001
FB-From baseline, OABSS- overactive bladder symptom score, IPSS- international prostate symptom score,IPSS-V: IPSS voiding sub score, IPSS-S: IPSS storage sub score, QOL: Quality of life FB-From baseline, OABSS- overactive bladder symptom score, IPSS- international prostate symptom score,IPSS-V: IPSS voiding sub score, IPSS-S: IPSS storage sub score, QOL: Quality of life FB-From baseline, OABSS- overactive bladder symptom score, IPSS- international prostate symptom score,IPSS-V: IPSS voiding sub score, IPSS-S: IPSS storage sub score, QOL: Quality of life FB-From baseline, OABSS- overactive bladder symptom score, IPSS- international prostate symptom score,IPSS-V: IPSS voiding sub score, IPSS-S: IPSS storage sub score, QOL: Quality of life FB-From baseline, OABSS- overactive bladder symptom score, IPSS- international prostate symptom score,IPSS-V: IPSS voiding sub score, IPSS-S: IPSS storage sub score, QOL: Quality of life FB-From baseline, OABSS- overactive bladder symptom score, IPSS- international prostate symptom score,IPSS-V: IPSS voiding sub score, IPSS-S: IPSS storage sub score, QOL: Quality of life