Table 1.
Baseline characteristics
| Tadalafil OaD (N = 139) | Tadalafil PRN (N = 143) a | Placebo (N = 141) | Overall (N = 423) a | |
|---|---|---|---|---|
| Age, years | ||||
| Mean (SD) | 58.6 (5.07) | 57.5 (5.91) | 57.6 (5.69) | 57.9 (5.58) |
| <61 years, n (%) | 82 (59.0) | 85(59.4) | 91 (64.5) | 258 (61.0) |
| 61-68 years, n (%) | 57 (41.0) | 58 (40.6) | 50 (35.5) | 165 (39.0) |
| nsRP approach, n (%) | ||||
| Open surgery | 68 (48.9) | 65 (45.5) | 56 (39.7) | 189 (44.7) |
| Conventional laparoscopy | 29 (20.9) | 31 (21.7) | 28 (19.9) | 88 (20.9) |
| Robot-assisted laparoscopy | 31 (22.3) | 41 (28.7) | 44 (31.2) | 116 (27.4) |
| Other | 11 (7.9) | 6 (4.2) | 13 (9.2) | 30 (7.1) |
| IIEF-EF at randomization (V4, after prostatectomy) | ||||
| N with data | 137 | 140 | 137 | 414 |
| Mean (SD) | 6.0 (5.80) | 6.7 (5.57) | 6.5 (6.08) | 6.4 (5.81) |
| EPIC sexual domain score | ||||
| N with data | 133 | 140 | 137 | 410 |
| Mean (SD) | 19.8 (19.56) | 21.9 (20.16) | 20.1 (21.87) | 20.6 (20.53) |
| EPIC urinary incontinence domain score | ||||
| N with data | 133 | 139 | 137 | 409 |
| Mean (SD) | 46.7 (30.71) | 47.9 (28.89) | 49.5 (28.05) | 48.0 (29.17) |
| EPIC urinary irritative/obstructive domain score | ||||
| N with data | 131 | 137 | 134 | 402 |
| Mean (SD) | 78.1 (18.92) | 81.5 (15.08) | 81.3 (16.42) | 80.4 (16.88) |
| EPIC bowel domain total score | ||||
| N with data | 129 | 134 | 136 | 399 |
| Mean (SD) | 88.3 (15.32) | 91.2 (10.31) | 89.9 (13.69) | 89.8 (13.27) |
| EPIC hormonal domain score | ||||
| N with data | 130 | 137 | 136 | 403 |
| Mean (SD) | 90.0 (12.71) | 92.0 (10.51) | 91.4 (10.89) | 91.2 (11.39) |
aData presented for all patients randomized. One patient assigned to tadalafil PRN did not receive any study drug and was therefore not included in the ITT population.
Abbreviations: EPIC Expanded Prostate Cancer Index Composite (EPIC-26), IIEF-EF International Index of Erectile Function – Erectile Function, ITT intent-to-treat, N number of patients, n number of patients with characteristic, nsRP bilateral nerve-sparing prostatectomy, NSS Nelson Nerve-Sparing score, OaD once daily, PRN “pro-re-nata”/on-demand, SD standard deviation, V visit EPIC scores range from 0–100, higher scores indicate better values.