Table 4.
Responsiveness of HRQoL and clinical symptoms
|
A. Overall population | ||||||
|---|---|---|---|---|---|---|
| Clinical symptom | Response in symptoms | N (%) | Change from baseline in utility EQ-5D, adjusted mean (±SD) a | P value vs. ‘Stable’ b | Change from baseline in utility OAB-5D, adjusted mean (±SD) a | P value vs. ‘Stable’ b |
| Micturitions/24 h |
Improvement ≥ 1 level |
2286 (56.4%) |
0.046 (±0.213) |
0.0058 |
0.076 (±0.092) |
<.0001 |
| Stable |
1260 (31.1%) |
0.027 (±0.202) |
NA |
0.039 (±0.087) |
NA |
|
| Worsening ≥ 1 level |
506 (12.5%) |
0.023 (±0.195) |
0.7291 |
0.021 (±0.085) |
0.0001 |
|
| Incontinence episodes/24 h |
Improvement ≥ 1 level |
1874 (46.3%) |
0.053 (±0.223) |
0.0002 |
0.081 (±0.096) |
<.0001 |
| Stable |
1849 (45.6%) |
0.028 (±0.206) |
NA |
0.042 (±0.089) |
NA |
|
| Worsening ≥ 1 level |
329 (8.1%) |
0.007 (±0.197) |
0.0662 |
0.022 (±0.086) |
<.0001 |
|
|
B. Patients with mild symptoms at baseline (level 1 to 3 in terms of micturitions frequency, or incontinence episodes) | ||||||
|
Clinical symptom |
Response in symptoms |
N (%) |
Change from baseline in utility EQ-5D, adjusted mean (±SD)
a
|
P value vs. ‘Stable’
b
|
Change from baseline in utility OAB-5D, adjusted mean (±SD)
a
|
P value vs. ‘Stable’
b
|
| Micturitions/24 h |
Improvement ≥ 1 level |
1329 (50.7%) |
0.046 (±0.205) |
0.3518 |
0.079 (±0.089) |
<.0001 |
| Stable |
863 (32.9%) |
0.038 (±0.197) |
NA |
0.047 (±0.085) |
NA |
|
| Worsening ≥ 1 level |
432 (16.5%) |
0.029 (±0.189) |
0.3886 |
0.021 (±0.082) |
<.0001 |
|
| Incontinence episodes/24 h |
Improvement ≥ 1 level |
1038 (35.9%) |
0.049 (±0.197) |
0.0416 |
0.079 (±0.099) |
<.0001 |
| Stable |
1564 (54.1%) |
0.033 (±0.191) |
NA |
0.046 (±0.102) |
NA |
|
| Worsening ≥ 1 level |
287 (9.9%) |
0.010 (±0.188) |
0.0628 |
0.023 (±0.087) |
<.0001 |
|
|
C. Patients with severe symptoms at baseline (level 4 or 5 in terms of micturitions frequency, or incontinence episodes) | ||||||
|
Clinical symptom |
Response in symptoms |
N (%) |
Change from baseline in utility EQ-5D, adjusted mean (±SD)
a
|
P value vs. ‘Stable’
b
|
Change from baseline in utility OAB-5D, adjusted mean (±SD)
a
|
P value vs. ‘Stable’
b
|
| Micturitions/24 h |
Improvement ≥ 1 level |
957 (67.0%) |
0.046 (±0.250) |
0.0004 |
0.074 (±0.098) |
<.0001 |
| Stable |
397 (27.8%) |
0.002 (±0.219) |
NA |
0.020 (±0.090) |
NA |
|
| Worsening ≥ 1 level |
74 (5.2%) |
-0.009 (±0.208) |
0.6873 |
0.022 (±0.090) |
0.8938 |
|
| Incontinence episodes/24 h | Improvement ≥ 1 level |
836 (71.9%) |
0.064 (±0.299) |
0.0004 |
0.078 (±0.143) |
<.0001 |
| Stable |
285 (24.5%) |
0.012 (±0.246) |
NA |
0.014 (±0.111) |
NA |
|
| Worsening ≥ 1 level | 42 (3.6%) | -0.019 (±0.219) | 0.3865 | 0.008 (±0.094) | 0.7158 | |
A. aSD: Standard deviation. bt-test to test the null hypothesis that the associated utility change equals the utility change in patients with “Stable” response. NA: Not applicable.
B. aSD: Standard deviation. bt-test to test the null hypothesis that the associated utility change equals the utility change in patients with “Stable” response. NA: Not applicable.
C. aSD: Standard deviation. bt-test to test the null hypothesis that the associated utility change equals the utility change in patients with “Stable” response. NA: Not applicable.