Table 1.
Baseline characteristics and status post nsRP
| Variable | Tadalafil OaD (N = 139) | Tadalafil PRN (N = 143) | Placebo (N = 141) |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 58.6 (5.07) | 57.5 (5.91) | 57.6 (5.69) |
| <61 (n, %) | 82 (59.0) | 85 (59.4) | 91 (64.5) |
| 61–68 (n, %) | 57 (41.0) | 58 (40.6) | 50 (35.5) |
| Ethnicity (n, %) | |||
| Caucasian | 137 (98.6) | 141 (98.6) | 138 (97.9) |
| BMI (kg/m2) | |||
| Mean (SD) | 26.6 (2.97) | 26.9 (2.93) | 27.1 (3.08) |
| IIEF-EF | |||
| N with data | 137 | 140 | 137 |
| Mean (SD) | 6.0 (5.80) | 6.7 (5.57) | 6.5 (6.08) |
| ED severity (IIEF-EF categories) (n, %)a | |||
| Missing | 2 (1.4) | 2 (1.4) | 4 (2.8) |
| Normal (26–30) | 4 (2.9) | 2 (1.4) | 2 (1.4) |
| Mild (17–25) | 5 (3.6) | 8 (5.6) | 9 (6.4) |
| Moderate (11–16) | 9 (6.5) | 10 (7.0) | 11 (7.8) |
| Severe (0–10) | 119 (85.6) | 120 (84.5) | 115 (81.6) |
| REF ≤ 3b | 137 (98.6) | 138 (97.2) | 141 (100) |
| nsRP approach (n, %) | |||
| Open surgery | 68 (48.9) | 65 (45.5) | 56 (39.7) |
| Conventional laparoscopy | 29 (20.9) | 31 (21.7) | 28 (19.9) |
| Robot-assisted laparoscopy | 31 (22.3) | 41 (28.7) | 44 (31.2) |
| Other | 11 (7.9) | 6 (4.2) | 13 (9.2) |
| Total nerve-sparing score post-nsRP (n, %) | |||
| Perfect (2) | 117 (84.2) | 116 (81.1) | 113 (80.1) |
| Not perfect (>2) | 22 (15.8) | 27 (18.9) | 28 (19.9) |
BMI body mass index, ED erectile dysfunction, IIEF-EF International Index of Erectile Function-Erectile Function, N total number of patients, n number of patients, nsRP bilateral nerve-sparing prostatectomy, OaD once a day, PRN “pro-re-nata”/on demand, REF residual erectile function, SD standard deviation
aBased on intent-to-treat population, excluding one patient from the tadalafil PRN group with no post-baseline data
bTwo patients in the tadalafil OaD group and two patients in the tadalafil PRN group had missing values