Table 2.
IIEF-EF and EHS scores and related outcomes
| Baseline |
1 month |
3 months |
6 months |
|||||
|---|---|---|---|---|---|---|---|---|
| Group A | Group B | Group A | Group B | Group A | Group B | Group A | Group B | |
| IIEF-EF | ||||||||
| N | 45 | 42 | 45 | 42 | 41 | 41 | 40 | 40 |
| Mean | 18.1 | 18.0 | 20.6 | 19.3 | 19.9 | 20.6 | 21.0 | 20.8 |
| 95% CI | (17.1, 19.1) | (16.9, 19.2) | (18.9, 22.3) | (17.9, 20.6) | (18.1, 21.6) | (19.2, 22) | (19.4, 22.6) | (19.3, 22.2) |
| Range | (11, 25) | (11, 25) | (11, 30) | (9, 28) | (3, 30) | (10, 30) | (7, 30) | (12, 30) |
| IIEF-EF change from baseline | ||||||||
| N | NA | NA | 45 | 42 | 41 | 41 | 40 | 40 |
| Mean | NA | NA | 2.5 | 1.2 | 1.7 | 2.4 | 2.7 | 2.7 |
| 95% CI | NA | NA | (1.1, 4) | (−0.1, 2.6) | (0.3, 3.1) | (1.2, 3.7) | (1.2, 4.2) | (1.3, 4.1) |
| Range | NA | NA | (−8, 14) | (−8, 9) | (−12, 12) | (−4, 12) | (−10, 10) | (−8, 14) |
| MCID in IIEF-EF, n (%) | ||||||||
| Yes | NA | NA | 25 (55.6) | 14 (33.3) | 20 (48.8) | 21 (51.2) | 23 (57.5) | 19 (47.5) |
| No | NA | NA | 20 (44.4) | 28 (66.7) | 21 (51.2) | 20 (48.8) | 17 (42.5) | 21 (52.5) |
| ED, n (%) | ||||||||
| No | - | - | 12 (26.7) | 4 (9.5) | 7 (17.1) | 5 (12.2) | 8 (20.0) | 8 (20.0) |
| Mild | 32 (71.1) | 28 (66.7) | 21 (46.7) | 27 (64.3) | 23 (56.1) | 28 (68.3) | 25 (62.5) | 24 (60.0) |
| Moderate | 13 (28.9) | 14 (33.3) | 12 (26.7) | 10 (23.8) | 9 (22.0) | 7 (17.1) | 5 (12.5) | 8 (20.0) |
| Severe | - | - | - | 1 (2.4) | 2 (4.9) | 1 (2.4) | 2 (5.0) | - |
| EHS | ||||||||
| N | 45 | 42 | 45 | 42 | 41 | 41 | 40 | 39 |
| Mean | 2.6 | 2.7 | 3.2 | 3 | 3.1 | 3 | 3.2 | 3.2 |
| 95% CI | (2.4, 2.8) | (2.5, 2.9) | (2.9, 3.4) | (2.8, 3.2) | (2.9, 3.3) | (2.8, 3.2) | (2.9, 3.4) | (2.9, 3.4) |
| Range | (1, 4) | (1, 3) | (1, 4) | (1, 4) | (1, 4) | (2, 4) | (0, 4) | (1, 4) |
| EHS change from baseline | 45 | 42 | 41 | 41 | 40 | 39 | ||
| N | NA | NA | 0.6 | 0.3 | 0.5 | 0.3 | 0.6 | 0.5 |
| Mean | NA | NA | (0.3, 0.8) | (0.1, 0.5) | (0.2, 0.8) | (0, 0.5) | (0.3, 0.8) | (0.2, 0.8) |
| 95% CI | NA | NA | (−1, 2) | (−1, 2) | (−1, 3) | (−1, 2) | (−1, 2) | (−2, 3) |
| Range | NA | NA | 45 | 42 | 41 | 41 | 40 | 39 |
| MCID in EHS, n (%) | ||||||||
| N | NA | NA | 15 | 12 | 13 | 11 | 13 | 11 |
| Yes | NA | NA | 12 (80.0) | 8 (66.7) | 8 (61.5) | 9 (81.8) | 10 (76.9) | 10 (90.9) |
| No | NA | NA | 3 (20.0) | 4 (33.3) | 5 (38.5) | 2 (18.2) | 3 (23.1) | 1 (9.1) |
ED = erectile dysfunction; EHS = Erectile Hardness Scale; IIEF-EF = International Index of Erectile Function-Erectile Function domain; MCID = minimal clinically important difference; NA = not applicable.
Group A: 5 daily treatments (720 shocks/d). Group B: 3 times a week for 2 weeks (600 shocks/d).
MCID in IIEF-EF was defined as increase of ≥2 for patients with baseline mild ED (baseline IIEF-EF score of 17–25), and ≥5 for patients with baseline moderate ED (score of 11–16).
MCID in EHS was defined as a change to score 3 or 4, among patients with baseline scores of 1 or 2.
ED categories based on the IIEF-EF score (range 0–30): scores 26–30, no; 17–25, mild; 11–16, moderate; 0–10, severe ED.
EHS range 0–4.
MCID in IIEF-EF within 6 months were 71% (32/45) and 59.5% (25/42) in Groups A and B, respectively, and the difference between groups was not statistically significant (P = .270).