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 |