Table 1.
Characteristics and outcomes of seven randomized trials of LiESWT for treatment of erectile dysfunction.
| Study (country) |
Srini16
(India) |
Olsen17
(Denmark) |
Yee18
(China) |
Vardi19
(Israel) |
Kitrey20
(Israel) |
Kalyvianakis21
(Greece) |
Fojecki22
(Denmark) |
|---|---|---|---|---|---|---|---|
| Year(s) treated | 2009–2011 | 2012–2013 | 2011–2012 | 2009–2010 | ND | ND | 2014 |
| Age [median range; mean ± SD] | |||||||
| sham | ND | 60 (37–79) | 63.3 ± 6.4 | 57 (35–77) | 64 (29–81) | 55.1 (38–72) | 63.3 ± 9.5 |
| treatment | ND | 59 (41–80) | 58.9 ± 7.6 | 58 (27–72) | 60 (28–78) | 53.0 (31–72) | 65.4 ± 7.9 |
| Treatment regimen | 12 total tx with LiESWT or sham; 1, 3, 6, 9, 12 months post-tx measures | 5 weeks sham or LiESWT; 5, 12, 24-wk post-tx measures | 12 total tx LiESWT or sham; 1-month post-tx measures | 12 total tx with LiESWT or sham; 1 and 3-month post-tx measures | 12 total tx with either LiESWT or sham; 1, 6, 12, 18, 24-month post-tx measures | 12 total tx with LiESWT or sham; 1,3,6,9, 12 months post-tx measures | 10 total tx with sham or LiESWT; 1 month post-tx measure |
| # randomized | |||||||
| sham | 40 | 54 | 34 | 21 | 18 | 16 | 63 |
| treatment | 95 | 51 | 36 | 46 | 40 | 30 | 63 |
| # completed trial | |||||||
| sham | 17 | 54 | 28 | 20 | 18 | 16 | 60 |
| treatment | 60 | 51 | 30 | 40 | 37 | 30 | 58 |
| Baseline IIEF-EF | |||||||
| sham | 9.2 (SD 3.6*) | ND | 10.2 SD 3.8 | 11.5 ± 0.86 | 8.0 (SD 3.215) †† | 14.6 SD 3.4 | 11.5 SD 6.6 |
| treatment | 9.5 (SD 3.6*) | ND | 10.2 SD 3.8 | 12.6 ± 0.75 | 7.67 (SD 3.072) †† | 13.8 SD 3.6 | 10.9 SD 7.1 |
| Follow-up IIEF-EF | |||||||
| sham | 10.6 (SD 4.3*) | ND | 15.8 SD 6.1 | 14.5 ± 0.86† | 8.17 (SD 3.215) †† | 16.43 SD 3.5 | 13.0 SD 7.9 |
| treatment | 22.0 (SD 4.3*) | ND | 17.8 SD 4.8 | 19.3 ± 0.75† | 13.33 (SD 6.933) †† | 18.46 SD 3.6 | 12.8 SD 7.8## |
| Change in IIEF-EF | |||||||
| sham | 1.4 (SD 3.7*) | ND | 3.8 SD 3.6 | 3.0 ± 1.4 | 0.08 (SD 1.81) †† | 1.83 SD 3.45††† | 1.5 SD 7.3††† |
| treatment | 12.5 (SD 4.3*) | ND | 5.3 SD 5.5 | 6.7 ± 0.9 | 4.83 (SD 7.32) †† | 4.66 SD 3.6††† | 2.2 SD 7.5††† |
| % IIEF-EF 5-point improvement | |||||||
| sham | ND | 37.1 | ND | 20 | 0 | 12.5# | 38.3 |
| treatment | ND | 43.2 | ND | 65 | 40.5 | 56.7# | 37.9 |
| % increasing EHS from ⩽2 to ⩾3 | |||||||
| sham | 0 | 9 | ND | 0 (n = 12) | 0 | ND | 6.7### |
| treatment | 90 | 57 | ND | 68.0 (n = 28) | 54.1 | ND | 3.5### |
CI, confidence interval; EHS, erection hardness scale; IIEF-EF, International Index of Erectile Function-Erectile Function domain; IQR, interquartile range; LiESWT, low-intensity extracorporeal shockwave therapy; ND, not described; SD, standard deviation; SEM, standard error of the mean; tx, treatment.
SD estimated using the relationship of IIEF-EF score per measured unit length (mm) on the y-axis to scale the length of the SD bars in Figure 2(b) (baseline and follow-up IIEF-EF), or Figure 2(a) (change in IIEF-EF).
SEM not described, assume values are the same as for baseline based on similar error bars in Figure 4.
mean and SD estimated from median and IQR using the method of Wan and colleagues6
SD of difference calculated with means and SDs from baseline and follow up for each treatment group
Percentage achieving ‘minimal clinically important difference’ with the size of difference not specified
Incorrect IIEF-EF score and 95% CI in published paper. First author provided corrected score and SD in email.
Results concerning the change in EHS were only available on a subset (n = 83), but the number within each group was not provided. We assumed that the ratio of sample sizes of sham:treatment for this endpoint would be the same as the corresponding ratio in all patients who completed the trial, (60:58 = 1.034). We estimated the number in the treatment group (nT) and sham group (np) by solving the following system of equations:
This gave an estimate of nT = 41, so np was estimated as 83 – 41 = 42.