Table 2.
Changes from baseline (Week 0) at Weeks 36 and 52
| Baseline | Mean change from baseline (P‐value) | P‐value between groups | |||
|---|---|---|---|---|---|
| Week 36 | Week 52 | Week 36 | Week 52 | ||
| OABSS | |||||
| Total score | |||||
| TD group | 7.7 ± 2.7 | −1.15 (<0.001) | −1.54 (<0.001) | <0.001 | 0.002 |
| TDI group | 7.9 ± 2.3 | −3.45 (<0.001) | −2.97 (<0.001) | ||
| Daytime frequency score | |||||
| TD group | 0.9 ± 0.5 | 0.04 (0.52) | −0.13 (0.06) | <0.001 | 0.03 |
| TDI group | 0.9 ± 0.5 | −0.31 (<0.001) | −0.34 (<0.001) | ||
| Nocturia score | |||||
| TD group | 2.3 ± 0.9 | −0.15 (0.13) | −0.25 (0.01) | 0.001 | 0.02 |
| TDI group | 2.2 ± 0.9 | −0.57 (<0.001) | −0.56 (<0.001) | ||
| Urgency score | |||||
| TD group | 3.2 ± 1.0 | −0.93 (<0.001) | −0.99 (<0.001) | <0.001 | 0.02 |
| TDI group | 3.3 ± 1.0 | −1.82 (<0.001) | −1.54 (<0.001) | ||
| Urgency incontinence score | |||||
| TD group | 1.4 ± 1.5 | −0.12 (0.44) | −0.17 (0.29) | 0.003 | 0.10 |
| TDI group | 1.4 ± 1.3 | −0.75 (<0.001) | −0.53 (<0.001) | ||
| IPSS | |||||
| Total score | |||||
| TD group | 14.1 ± 5.9 | −3.49 (<0.001) | −4.16 (<0.001) | 0.01 | 0.66 |
| TDI group | 13.8 ± 5.9 | −5.68 (<0.001) | −4.47 (<0.001) | ||
| Voiding score | |||||
| TD group | 6.8 ± 4.7 | −2.10 (<0.001) | −2.81 (<0.001) | 0.36 | 0.24 |
| TDI group | 6.5 ± 4.3 | −2.68 (<0.001) | −2.08 (<0.001) | ||
| Storage score | |||||
| TD group | 7.2 ± 2.7 | −1.34 (<0.001) | −1.35 (<0.001) | <0.001 | 0.02 |
| TDI group | 7.3 ± 2.8 | −3.00 (<0.001) | −2.40 (<0.001) | ||
| IPSS‐QOL score | |||||
| TD group | 4.5 ± 1.0 | −0.84 (<0.001) | −1.05 (<0.001) | <0.001 | 0.048 |
| TDI group | 4.4 ± 1.1 | −1.72 (<0.001) | −1.48 (<0.001) | ||
| BPH impact index | |||||
| TD group | 5.0 ± 3.7 | −1.32 (<0.001) | −1.36 (<0.001) | 0.01 | 0.04 |
| TDI group | 5.2 ± 3.8 | −2.54 (<0.001) | −2.35 (<0.001) | ||
| No. voids/24 ha | |||||
| TD group | 11.4 ± 3.5 | – | −0.39 (0.30) | – | 0.23 |
| TDI group | 10.7 ± 2.5 | – | −0.82 (0.01) | ||
| No. episodes urgency/24 ha | |||||
| TD group | 3.1 ± 3.3 | – | −1.12 (0.09) | – | 0.84 |
| TDI group | 3.0 ± 3.0 | – | −0.99 (0.01) | ||
| No. episodes urgency incontinence/24 ha | |||||
| TD group | 1.9 ± 3.3 | – | −1.50 (0.38) | – | 0.19 |
| TDI group | 1.1 ± 1.1 | – | −0.31 (0.21) | ||
| Urine volume/24 h (mL)a | |||||
| TD group | 1677 ± 620 | – | 21.4 (0.77) | – | 0.33 |
| TDI group | 1637 ± 564 | – | 91.4 (0.09) | ||
| Mean voided volume/micturition (mL)a | |||||
| TD group | 160 ± 59 | – | 3.2 (0.65) | – | 0.004 |
| TDI group | 195 ± 92 | – | 24.2 (<0.001) | ||
| Prostate volume (% change) | |||||
| TD group | 43.7 ± 15.1 | – | −25.8 (<0.001) | – | 0.69 |
| TDI group | 44.6 ± 18.8 | – | −27.2 (<0.001) | ||
| Qmax (mL/s) | |||||
| TD group | 11.3 ± 4.8 | – | 0.89 (0.21) | – | 0.16 |
| TDI group | 11.7 ± 6.1 | – | 2.88 (0.13) | ||
| PVR (mL) | |||||
| TD group | 24.2 ± 25.8 | – | 0.33 (0.95) | – | 0.01 |
| TDI group | 22.3 ± 25.6 | – | 17.2 (0.01) | ||
| PSA (% change) | |||||
| TD group | 4.1 ± 4.1 | – | −49.9 (<0.001) | – | 0.98 |
| TDI group | 3.3 ± 2.6 | – | −50.0 (<0.001) | ||
| Testosterone (% change) | |||||
| TD group | 7.6 ± 12.7 | – | 13.3 (0.006) | – | 0.84 |
| TDI group | 6.0 ± 10.5 | – | 12.0, 0.04 | ||
Abbreviations: BPH, benign prostatic hyperplasia; IPSS, International Prostate Symptom Score; OABSS, Overactive Bladder Symptom Score; PSA, prostate‐specific antigen; PVR, post‐void residual; Qmax, maximum flow rate; QOL, quality of life; TD, tamsulosin + dutasteride; TDI, tamsulosin + dutasteride + imidafenacin.
Baseline data are given as the mean ± SD.
a
Evaluated using a frequency volume chart.