Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction

Jeffrey D Campbell, Bruce J Trock, Adam R Oppenheim, Ifeanyichukwu Anusionwu, Ronak A Gor, Arthur L Burnett, Jeffrey D Campbell, Bruce J Trock, Adam R Oppenheim, Ifeanyichukwu Anusionwu, Ronak A Gor, Arthur L Burnett

Abstract

Background: The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) that evaluate the efficacy of low-intensity extracorporeal shock wave therapy (LiESWT) for the treatment of erectile dysfunction (ED).

Materials and methods: A comprehensive search of PubMed, Medline, and Cochrane databases was performed from November 2005 to July 2018. RCTs evaluating efficacy of LiESWT in the treatment of ED were selected. The primary outcomes were the mean difference between treatment and sham patients in the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score 1 month after treatment, and the mean change in IIEF-EF from baseline to 1 month post-treatment. The secondary analysis considered the percentage of men whose erectile hardness score (EHS) changed from <2 at baseline to >3 after treatment. All analyses used a random effects method to pool study-specific results.

Results: A total of seven RCTs provided data for 607 patients. The mean IIEF-EF 1 month post-treatment ranged from 12.8 to 22.0 in the treatment group versus 8.17-16.43 in the sham group. The mean difference between the treatment and sham groups at the 1 month follow up was a statistically significant increase in IIEF-EF of 4.23 (p = 0.012). Overall, five of the seven trials provided data on the proportion of patients with baseline EHS <2 who improved to EHS >3 at 1 month post-treatment. The proportions ranged from 3.5 to 90% in the treatment group versus 0-9% in the sham group and the pooled relative risk of EHS improvement for the treated versus sham group was 6.63 (p = 0.0095). No significant adverse events were reported.

Conclusions: This is the first meta-analysis that evaluates RCTs exploring LiESWT as a treatment modality strictly for ED. This therapeutic strategy appears to be well tolerated with short-term benefits. However further studies exploring specific treatment regimens and long-term outcomes are needed.

Keywords: IIEF; erectile dysfunction; low-intensity extracorporeal shock wave therapy; randomized trials.

Conflict of interest statement

Conflict of interest statement: Authors I. Anusionwu and A.L. Burnett have received research grants from Medispec Ltd. The remaining authors declare no conflict of interest

Figures

Figure 1.
Figure 1.
Preferred PRISMA flowchart depicting the search strategy and article selection process. ED, erectile disfunction; LiESWT, low-intensity extracorporeal shock wave therapy; PRISMA, Reporting Items for Systematic Reviews and Meta-Analysis; RCT, randomized controlled trial.
Figure 2.
Figure 2.
Difference in International Index of Erectile Function-Erectile Function domain score at 1 month post-treatment follow up between treated versus placebo patients.
Figure 3.
Figure 3.
Mean change in International Index of Erectile Function-Erectile Function domain score from baseline to post-treatment follow up in treated versus placebo patients.
Figure 4.
Figure 4.
Relative risk of treatment versus placebo for percentage with International Index of Erectile Function-Erectile Function domain score increase of 5 points or greater at post-treatment follow up.
Figure 5.
Figure 5.
Relative risk of treatment versus placebo for increase in erectile hardness score to 3 or greater at post-treatment follow up.

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Source: PubMed

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