Table 1. Baseline characteristics of patients.
| Characteristic | ITT (n=41) | p-valuea | PP (n=26) | p-valuea | ||
|---|---|---|---|---|---|---|
| KBMSI-2 (n=21) | Placebo (n=20) | KBMSI-2 (n=14) | Placebo (n=12) | |||
| Smoking | 0.0478b | 0.2031b | ||||
| Non-smoker | 21 (100.0) | 16 (80.0) | 14 (100.0) | 10 (83.3) | ||
| Smoker | ||||||
| Alcohol consumption | 0 (0.0) | 4 (20.0) | 0.4123b | 0 (0.0) | 2 (16.7) | 0.6709b |
| Yes | 11 (52.4) | 13 (65.0) | 7 (50.0) | 7 (58.3) | ||
| No | 10 (47.6) | 7 (35.0) | 7 (50.0) | 5 (41.7) | ||
| Age (y) | 55.43±9.61 (35–73) | 57.70±7.87 (38–71) | 0.4142 | 59.14±7.54 (47–74) | 58.75±7.36 (46–72) | 0.8946 |
| Duration of ED (y) | 3.89±2.58 (1–10) | 5.62±3.74 (0.83–13) | 0.0913 | 4.46±2.53 (2–10) | 5.11±2.88 (1–10) | 0.5480 |
| Category of ED | 0.5231b | 0.7690b | ||||
| Arteriogenic | 17 (81.0) | 13 (65.0) | 12 (85.7) | 9 (75.0) | ||
| Venogenic | 3 (14.3) | 6 (30.0) | 2 (14.3) | 3 (25.0) | ||
| Psychogenic | 1 (4.8) | 1 (5.0) | 0 (0.0) | 0 (0.0) | ||
| Medical history | 0.4311b | 0.6707b | ||||
| Diabetes mellitus | 9 (42.9) | 8 (40.0) | 7 (50.0) | 7 (58.3) | ||
| Hypertension | 7 (33.3) | 8 (40.0) | 6 (42.9) | 5 (41.7) | ||
| Dyslipidemia | 5 (23.8) | 3 (15.0) | 4 (28.6) | 3 (25.0) | ||
| IIEF | ||||||
| Erectile function | 14.43±7.18 | 15.05±6.72 | 0.7766 | 14.86±6.36 | 16.58±5.84 | 0.4807 |
| Intercourse satisfaction | 5.38±2.69 | 6.15±3.41 | 0.4263 | 5.71±2.55 | 6.92±2.91 | 0.2725 |
| Orgasmic function | 4.67±2.61 | 5.30±3.26 | 0.4957 | 5.00±2.18 | 6.17±3.10 | 0.2730 |
| Sexual desire | 5.10±1.51 | 5.80±1.77 | 0.1771 | 5.21±1.37 | 6.00±1.81 | 0.2200 |
| Overall satisfaction | 5.29±1.79 | 6.15±1.31 | 0.0870 | 5.57±1.74 | 6.08±1.31 | 0.4122 |
| Total | 34.86±14.65 | 38.45±14.87 | 0.4405 | 36.36±12.82 | 41.75±12.91 | 0.2971 |
| Sexual Encounter Profile | ||||||
| Question 2 | 75.00±42.15 | 76.79±40.99 | 0.8927 | 77.50±32.15 | 83.33±38.92 | 0.7675 |
| Question 3 | 52.50±44.35 | 49.95±45.86 | 0.8592 | 51.43±37.80 | 52.50±48.45 | 0.2743 |
| Aging Males' Symptoms score | 38.00±12.07 | 36.55±14.51 | 0.7293 | 41.14±12.15 | 40.00±16.81 | 0.8426 |
| ADAM (no. of positive response) | 5.24±2.19 | 5.05±2.39 | 0.7941 | 5.86±1.66 | 5.17±2.17 | 0.3668 |
| Total testosterone (ng/mL) | 4.43±1.57 | 4.29±1.35 | 0.7577 | 4.69±1.65 | 4.41±1.50 | 0.6587 |
| Peak systolic velocity (cm/s) | 10.05±5.05 | 11.61±4.55 | 0.5937 | 10.23±5.60 | 12.14±4.17 | 0.3398 |
| End diastolic velocity (cm/s) | 3.68±1.80 | 5.85±3.14 | 0.0114 | 3.91±2.00 | 5.82±3.03 | 0.0665 |
Values are presented as number (%), mean±SD (minimun–maximum), or mean±SD only.
ITT, intention to treat; PP, per-protocol; ED, erectile dysfunction; IIEF, International Index of Erectile Function; ADAM, Androgen Deficiency in Aging Males; SD, standard deviation.
a:t-test or chi-square test, b:Fisher's exact test.