Table 5 Changes in voiding diary parameters after treatment between the groups at each study visit (Per-Protocol Set).
Control group | HACS group | P† | |
|---|---|---|---|
Daytime frequency | |||
1mo | |||
n | 54 | 45 | |
Mean change from baseline | − 5.08 ± 6.85 | − 5.44 ± 5.75 | 0.757 |
P* | < 0.001 | < 0.001 | |
6mo | |||
n | 45 | 34 | |
Mean change from baseline | − 3.07 ± 4.37 | − 4.39 ± 7.60 | 0.751 |
P* | < 0.001 | < 0.001 | |
9mo | |||
n | 32 | 32 | |
Mean change from baseline | − 3.22 ± 3.62 | − 6.19 ± 6.53 | 0.029 |
P* | < 0.001 | < 0.001 | |
12mo | |||
n | 32 | 31 | |
Mean change from baseline | − 2.22 ± 4.18 | − 4.0 ± 5.64 | 0.159 |
P* | 0.005 | < 0.001 | |
18mo | |||
n | 6 | 30 | |
Mean change from baseline | − 3.64 ± 3.62 | − 4.57 ± 5.58 | 0.700 |
P* | 0.057 | < 0.001 | |
24mo | |||
n | 3 | 23 | |
Mean change from baseline | − 0.55 ± 4.74 | − 5.2 ± 6.28 | NA |
P* | NA | < 0.001 | |
Nocturia | |||
1mo | |||
n | 54 | 45 | |
Mean change from baseline | − 1.68 ± 2.39 | − 1.17 ± 1.88 | 0.419 |
P* | < 0.001 | < 0.001 | |
6mo | |||
n | 45 | 34 | |
Mean change from baseline | − 0.76 ± 1.63 | − 0.75 ± 1.92 | 0.905 |
P* | < 0.001 | 0.030 | |
9mo | |||
n | 32 | 32 | |
Mean change from baseline | − 0.89 ± 2.00 | − 0.95 ± 2.01 | 0.768 |
P* | 0.009 | 0.012 | |
12mo | |||
n | 32 | 31 | |
Mean change from baseline | − 0.85 ± 1.81 | − 1.23 ± 1.97 | 0.398 |
P* | 0.012 | 0.002 | |
18mo | |||
n | 6 | 30 | |
Mean change from baseline | − 1.53 ± 1.41 | − 1.00 ± 2.44 | 0.615 |
P* | 0.050 | 0.033 | |
24mo | |||
n | 3 | 22 | |
Mean change from baseline | 0 ± 2.52 | − 0.98 ± 2.18 | NA |
P* | NA | 0.047 | |
Urgency episode | |||
1mo | |||
n | 54 | 40 | |
Mean change from baseline | − 8.55 ± 11.35 | − 6.91 ± 8.93 | 0.652 |
P* | < 0.001 | < 0.001 | |
6mo | |||
n | 45 | 29 | |
Mean change from baseline | − 6.98 ± 9.49 | − 4.6 ± 11.11 | 0.327 |
P* | < 0.001 | 0.034 | |
9mo | |||
n | 32 | 27 | |
Mean change from baseline | − 7.28 ± 8.17 | − 8.26 ± 9.76 | 0.675 |
P* | < 0.001 | < 0.001 | |
12mo | |||
n | 32 | 26 | |
Mean change from baseline | − 5.59 ± 8.00 | − 6.59 ± 9.16 | 0.328 |
P* | < 0.001 | 0.001 | |
18mo | |||
n | 6 | 25 | |
Mean change from baseline | − 5.91 ± 9.28 | − 6.69 ± 10.45 | 869 |
P* | 0.179 | 0.004 | |
24mo | |||
n | 3 | 18 | |
Mean change from baseline | − 5.11 ± 11.08 | − 6.83 ± 8.44 | NA |
P* | NA | 0.003 | |