Is low-intensity shock wave therapy effective for treating erectile dysfunction in men, particularly those with a history of intracavernosal alprostadil injections?

Low-Intensity Shock Wave Therapy for Erectile Dysfunction

Low-intensity shock wave therapy (LiSWT) may provide modest improvements in erectile function for men with mild-to-moderate vasculogenic erectile dysfunction, but the clinical significance of these improvements is questionable, and current AUA guidelines do not recommend it as standard therapy. 1

Evidence Quality and Guideline Position

The most recent and comprehensive evidence comes from a 2025 Cochrane systematic review of 21 randomized controlled trials involving 1,357 men. 2 Notably, the 2018 AUA Erectile Dysfunction Guideline does not mention LiSWT as a recommended treatment option, focusing instead on established therapies including PDE5 inhibitors, vacuum erection devices, intraurethral alprostadil, intracavernosal injections, and penile prosthesis. 1

The European Association of Urology provides only a weak recommendation for LiSWT in mild vasculogenic ED, and does not recommend it for treating established penile fibrosis or other complications. 3

Efficacy Data

Short-Term Outcomes (≤3 months)

• LiSWT may increase IIEF-EF scores by 3.89 points compared to sham treatment, but this falls below the minimal clinically important difference of 4 points. 2
• Penile rigidity (measured by Erectile Hardness Scale) may improve by 1.06 points, which meets the minimal clinically important difference of 1 point. 2
• The certainty of this evidence is low due to study limitations, inconsistency, and imprecision. 2

Long-Term Outcomes (>3 months)

• IIEF-EF scores may increase by 5.25 points at long-term follow-up, which exceeds the minimal clinically important difference. 2
• However, this is based on only 5 studies with 276 participants and very high heterogeneity (I² = 87%). 2

Safety Profile

LiSWT appears to have minimal adverse effects, with no difference in treatment-related adverse events compared to sham treatment in both short-term and long-term follow-up. 2 Treatment discontinuation rates are similar to placebo. 2

Patient Selection Considerations

The evidence base primarily includes men with:

• Baseline IIEF-EF scores of 7-20 (mild-to-moderate ED). 2
• Vasculogenic etiology of erectile dysfunction. 4
• Previous response to PDE5 inhibitors. 5, 4

For men with severe ED (EHS ≤2) who respond poorly to PDE5 inhibitors, one open-label study showed potential benefit, with 72.4% achieving EHS ≥3 when LiSWT was combined with PDE5 inhibitor therapy. 5 However, this was not a placebo-controlled trial and represents lower-quality evidence.

Specific Context: Men Using Intracavernosal Alprostadil

For men currently using intracavernosal alprostadil injections:

The established AUA-recommended treatment pathway should be followed first: 1

• Ensure proper injection technique through retraining to optimize efficacy and minimize complications. 6
• Consider transitioning to PDE5 inhibitors if not previously tried or if they failed at inadequate doses. 6, 3
• Consider intraurethral alprostadil (64.9% success rate for intercourse) to avoid continued corporal trauma. 1
• Consider vacuum erection devices with vacuum limiters as an alternative non-invasive option. 1

LiSWT is not mentioned in AUA guidelines as a treatment for complications of intracavernosal therapy and should not replace established treatment algorithms. 1

Critical Limitations

• No data on patient/partner satisfaction or sexual quality of life in any timeframe. 2
• Most studies were industry-funded by device manufacturers, raising concerns about bias. 2
• High heterogeneity between studies (I² ranging from 53% to 89% for various outcomes). 2
• Treatment protocols vary widely across studies with no standardized approach. 7
• The most common protocol involves 1,500 shocks per session (900 to penis, 600 to crura) at 0.09 mJ/mm² energy and 5 Hz frequency, but this lacks definitive validation. 7

Clinical Recommendation

Given the absence of LiSWT in current AUA guidelines and the low certainty of available evidence, men with erectile dysfunction should be offered established first-line therapies (PDE5 inhibitors, vacuum devices, intraurethral or intracavernosal alprostadil, and ultimately penile prosthesis for refractory cases). 1

If LiSWT is considered, it should be:

• Limited to men with mild-to-moderate vasculogenic ED who have failed or cannot tolerate standard therapies. 3, 2
• Presented as an investigational option with uncertain long-term benefits. 2
• Combined with PDE5 inhibitors for potentially enhanced results. 3, 5
• Not used as a substitute for addressing underlying cardiovascular risk factors or optimizing established ED treatments. 1

For men with a history of intracavernosal alprostadil use specifically, prioritize optimizing injection technique, transitioning to alternative established therapies, and monitoring for complications like penile fibrosis rather than pursuing LiSWT. 6, 3