Table 2.
Variables at baseline, 1, 4, and 12 weeks in patients in ESWT and placebo.
| Variable | Placebo (N = 12) | ESWT (N = 13) | P valueb | ||
|---|---|---|---|---|---|
| Mean (95% CI) | p value a | Mean (95% CI) | P valuea | ||
| O' Leary-Sant score | |||||
| Baseline | 25.6 (22.5, 28.6) | 26.0 (22.6, 29.4) | 0.834 | ||
| Wk 1 | 23.6 (19.8, 27.3) | 0.061 | 20.4 (16.9, 23.9) | < 0.0001**** | |
| Wk 4 | 24.8 (21.3, 28.3) | 0.512 | 20.6 (16.6, 24.6) | < 0.0001**** | |
| Wk 12 | 25.1 (20.7, 29.6) | 0.061 | 18.2 (13.2, 23.1) | < 0.0001**** | |
| ICSI | |||||
| Baseline | 12.3 (10.1, 14.5) | 12.7 (10.6, 14.8) | 0.789 | ||
| Wk 1 | 10.8 (8.1, 13.6) | 0.056 | 9.3 (7.1, 11.5) | 0.001*** | |
| Wk 4 | 11.7 (8.9, 14.6) | 0.511 | 9.2 (6.9, 11.5) | < 0.0001**** | |
| Wk 12 | 11.8 (8.4, 15.2) | 0.958 | 7.9 (5.0, 10.9) | < 0.0001**** | |
| ICPI | |||||
| Baseline | 13.3 (11.5, 15.0) | 13.3 (11.8, 14.8) | 0.954 | ||
| Wk 1 | 12.7 (11.1, 14.4) | 0.518 | 11.1 (9.4, 12.7) | 0.001*** | |
| Wk 4 | 13.1 (11.8, 14.4) | 0.795 | 11.2 (9.4, 13.1) | 0.001*** | |
| Wk 12 | 13.3 (11.5, 15.1) | 0.567 | 10.2 (8.0, 12.5) | 0.001*** | |
| VAS | |||||
| Baseline | 5.3 (4.2, 6.3) | 6.9 (5.8, 8.0) | 0.017* | ||
| Wk 1 | 5.1 (4.0, 6.2) | 0.513 | 4.9 (3.4, 6.3) | < 0.0001**** | |
| Wk 4 | 4.8 (4.0, 6.1) | 0.192 | 4.9 (3.3, 6.4) | < 0.0001**** | |
| Wk 12 | 5.2 (3.1, 7.3) | 0.862 | 4.7 (3.0, 6.4) | < 0.0001**** | |
| FBC (ml) | |||||
| Baseline | 282.1 (197.3, 366.8) | 315.4 (258.0, 372.8) | 0.456 | ||
| Wk 1) | 238.9 (163.5, 314.3) | 0.037* | 287.7 (231.9, 343.5) | 0.161 | |
| Wk 4 | 294.6 (194.9, 394.2) | 0.381 | 296.9 (225.8, 368.0) | 0.359 | |
| Wk 12 | 250.6 (142.0, 359.2) | 0.222 | 293.2 (218.5, 367.8) | 0.177 | |
| Frequency | |||||
| Baseline | 11.6 (7.7, 15.5) | 11.1 (8.8, 13.4) | 0.793 | ||
| Wk 1 | 12.4 (9.0, 15.8) | 0.376 | 10.2 (7.7, 12.7) | 0.088 | |
| Wk 4 | 12.0 (8.5, 15.8) | 0.908 | 10.4 (7.2, 13.6) | 0.331 | |
| Wk 12 | 12.6 (7.2, 18.1) | 0.022* | 9.8 (6.7, 13.0) | 0.005** | |
| Nocturia | |||||
| Baseline | 2.6 (1.4, 3.8) | 1.7 (0.7, 2.8) | 0.196 | ||
| Wk 1 | 2.9 (1.5, 4.3) | 0.243 | 1.7 (0.7, 2.6) | 0.792 | |
| Wk 4 | 2.3 (1.0, 3.6) | 0.380 | 1.6 (0.6, 2.7) | 0.780 | |
| Wk 12 | 3.9 (1.4, 6.4) | 0.125 | 1.8 (0.7, 0.9) | 0.889 | |
| Qmax (ml/s) | |||||
| Baseline | 14.4 (8.5, 20.2) | 16.3 (12.0, 20.7) | 0.533 | ||
| Wk 1 | 17.5 (9.9, 25.2) | 0.373 | 16.8 (13.4, 20.3) | 0.663 | |
| Wk 4 (N = 11, 13) | 17.6 (10.5, 24.6) | 0.329 | 17.1 (11.9, 22.4) | 0.705 | |
| Wk 12 (N = 8, 11) | 21.1 (11.5, 30.6) | 0.290 | 16.0 (12.9, 19.1) | 0.873 | |
| Voided volume (ml) | |||||
| Baseline | 172.0 (112.1, 231.8) | 256.9 (187.5, 326.4) | 0.034* | ||
| Wk 1 | 185.0 (129.2, 240.8) | 0.835 | 277.0 (199.4, 354.6) | 0.316 | |
| Wk 4 | 238.6 (150.0, 327.1) | 0.075 | 248.8 (163.4, 334.3) | 0.792 | |
| Wk 12 | 243.1 (177.2, 308.9) | 0.106 | 320.6 (210.8, 430.4) | 0.038* | |
| Residual urine (ml) | |||||
| Baseline | 25.0 (7.7, 42.4) | 33.8 (17.0, 50.5) | 0.408 | ||
| Wk 1 | 32.1 (10.6, 53.6) | 0.680 | 25.5 (15.7, 35.2) | 0.303 | |
| Wk 4 | 31.7 (9.1, 54.4) | 0.415 | 28.8 (5.6, 51.9) | 0.409 | |
| Wk 12 | 31.3 (6.1, 56.5) | 0.590 | 38.5 (13.7, 63.3) | 0.748 | |
| GRA (< 2/ ≥ 2) | |||||
| Wk 1 | 9/2 (18.2%) | 6/7 (53.8%) | 0.105c | ||
| Wk 4 | 8/3 (27.3%) | 6/7 (53.8%) | 0.240c | ||
| Wk 12 | 8/1 (11.1%) | 6/7 (53.8%) | 0.074c | ||
Values are presented as mean (95% CI).
FBC functional bladder capacity, the maximal voided volume that appears in the three-day voiding diary, Voided volume obtained from uroflowmetry to test the amount of urine voided during urination.
*P < 0.05, **P < 0.01, ***P < 0.005, ****P < 0.0001.
aGeneralized estimating equation compared with baseline.
bComparison between corresponding time point of ESWT and placebo (generalized estimating equation).
cComparison between corresponding time point of ESWT and placebo (Fisher's exact test).