Ergun O. et al., 2026: Low-intensity shockwave therapy for erectile dysfunction: An abridged Cochrane review.

Ergun O, Kim K, Kim MH, Hwang EC, Blair Y, Gudeloglu A, Parekattil S, Dahm P.
BJU Int. 2026 Jun;137(6):949-957. doi: 10.1111/bju.70236. Epub 2026 Mar 30.

Abstract

Objective: To assess the efficacy and safety of low-intensity shockwave therapy (LiSWT) for treating erectile dysfunction (ED) compared to sham therapy.

Methods: This summary is based on the Cochrane systematic review published in the Cochrane Database of Systematic Reviews 2025, Issue 7 (CD013166). We included randomised controlled trials (RCTs) comparing LiSWT to sham therapy. We excluded psychogenic or iatrogenic ED, kidney transplants, or radical prostatectomy. Critical outcomes were erectile function, discontinuation, and adverse events; important outcomes included rigidity, satisfaction, and quality of life. Certainty was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.

Results: A total of 21 RCTs (1357 men, aged 39-65 years) were analysed. LiSWT may slightly improve short-term erectile function (mean difference [MD] 3.89, 95% confidence interval [CI] 2.89-4.89; I2 = 62%; 15 studies; low-certainty), though clinical importance is uncertain. Long-term function may improve (MD 5.25, 95% CI 2.47-8.04; I2 = 87%; five studies; low-certainty). LiSWT likely has little effect on discontinuation (risk ratio 0.77, 95% CI 0.47-1.27; I2 = 0%) or adverse events (risk difference 0.00, 95% CI -0.01 to 0.02; I2 = 0%). It may improve short-term penile rigidity (MD 1.06, 95% CI 0.83-1.28; I2 = 53%; low-certainty). Data for satisfaction or quality of life were unavailable.

Conclusions: Low-intensity shockwave therapy may improve long-term erectile function and short-term rigidity, with little difference in discontinuation or adverse events. Evidence certainty is low due to methodological limitations and heterogeneity.

Comment Jens Rasseiler

This abridged Cochrane review assessed whether low-intensity shockwave therapy (LiSWT) improves erectile dysfunction compared with sham treatment. The review included 21 randomized controlled trials involving 1357 men, mostly aged between about 39 and 65 years, with organic or mixed erectile dysfunction. Trials involving psychogenic, neurological, iatrogenic ED, kidney transplant patients, or post-radical prostatectomy ED were excluded.

Main findings

Compared with sham therapy, LiSWT may slightly improve short-term erectile function (< 3 months) with mean improvement: 3.89 points on the IIEF-EF scale and penile rigidity with mean improvement of 1.06 points on the Erection Hardness Score

LiSWT may also improve long-term erectile function > 3 months) with mean improvement: 5.25 points on the IIEF-EF scale

LiSWT has little to no effect on adverse events.

However, no usable evidence was found for patient/partner satisfaction or sexual quality of life, which are clinically important outcomes.

Discussion

This review is important because LiSWT is often marketed as a “restorative” treatment for erectile dysfunction, but the evidence base has been uneven. The review suggests that LiSWT is probably safe in the short term, but its true clinical benefit remains uncertain.

The key issue is not whether LiSWT produces a statistically detectable improvement; it appears that it may. The more important question is whether the improvement is clinically meaningful. For short-term erectile function, the mean improvement was 3.89 points on the IIEF-EF scale, just under the authors’ chosen minimal clinically important difference of 4 points. That makes the result borderline. Long-term improvement was larger at 5.25 points, but this was based on fewer studies and showed substantial heterogeneity.

The high heterogeneity is a major limitation. Treatment protocols varied widely, including differences in:

• device type,
• number of treatment sessions,
• shock number,
• energy settings,
• treatment duration,
• baseline ED severity,
• PDE5 inhibitor use,
• patient selection.

This makes it difficult to say which patients are most likely to benefit, what protocol should be used, or whether some devices are better than others.

Another major weakness is trial quality. Many studies had unclear or high risk of bias, especially around allocation concealment, blinding, attrition, and selective reporting. Only a small number had pre-registered protocols. This lowers confidence in the apparent benefits.

Practical interpretation

LiSWT can reasonably be viewed as a promising but still incompletely proven therapy for erectile dysfunction, particularly vasculogenic ED. It may be attractive because it appears to have few adverse effects and aims to improve penile blood flow rather than simply produce temporary pharmacologic erections.

However, based on this review, it should not be presented as a guaranteed or definitively established treatment.

Conclusion

LiSWT for erectile dysfunction appears safe and possibly beneficial, but the evidence remains low-certainty. It may improve erectile function and rigidity, especially in some men with organic or vasculogenic ED, but current data are not strong enough to define it as a clearly established standard treatment. More rigorous trials are needed.

Jens Rassweiler