Is low-intensity extracorporeal shockwave therapy (Li-ESWT) an effective treatment option for erectile dysfunction (ED)?

Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction

Low-intensity extracorporeal shockwave therapy (Li-ESWT) may be used in men with mild vasculogenic erectile dysfunction (ED), but it offers only modest benefits and should not be considered a first-line treatment option. 1

Efficacy of Li-ESWT for ED

Current Evidence and Recommendations

• The European Association of Urology (EAU) 2025 guidelines provide a weak recommendation for Li-ESWT, indicating it may be used specifically in men with mild vasculogenic ED 1
• Li-ESWT shows modest improvement in erectile function:
  • Average improvement of approximately 4 points on the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score 1
  • Effects tend to diminish over time, though some studies report benefits lasting up to 5 years in select cases 1

Patient Selection and Expectations

• Best candidates are men with mild vasculogenic ED
• The benefit appears mild and may not be perceived as clinically significant by many patients 1
• Currently lacks a standardized treatment protocol, making consistent outcomes difficult to predict 1

Treatment Protocols and Outcomes

Treatment Parameters

• Most studies utilize:
  • 3,000 shockwaves per session
  • Energy levels of 0.09-0.25 mJ/mm²
  • Frequency of 4-6 Hz
  • Treatment schedule of twice weekly for 3 weeks 2, 3

Clinical Outcomes

• Meta-analyses show Li-ESWT can significantly improve IIEF scores (mean difference: 2.00; 95% CI, 0.99-3.00) 4
• In PDE5i non-responders, combination therapy with Li-ESWT and PDE5i showed:
  • Mean IIEF-EF increase of 8.6 points
  • 70.7% of patients achieving clinically significant improvement
  • 67.9% reporting erection hardness sufficient for intercourse 2

Combination Therapy Approaches

Li-ESWT with PDE5 Inhibitors

• Li-ESWT has shown benefit in PDE5i non-responders 1
• Combination of Li-ESWT with other treatments (VEDs or daily tadalafil) has shown enhanced results 1
• For patients with concurrent ED and Peyronie's disease, combination therapy may be particularly beneficial 5

Treatment Algorithm for ED

1. First-line treatments (should be tried before considering Li-ESWT):

   • PDE5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil)
   • Lifestyle modifications (weight loss, exercise, smoking cessation)

2. Second-line treatments (for those who fail or cannot use PDE5i):

   • Vacuum erection devices
   • Intracavernous injection therapy
   • Intraurethral alprostadil

3. Consider Li-ESWT only for:

   • Patients with mild vasculogenic ED
   • PDE5i non-responders who wish to avoid more invasive options
   • As part of combination therapy with PDE5i

4. Third-line treatment:

   • Penile prosthesis implantation

Important Considerations and Limitations

Safety Profile

• Li-ESWT appears to be safe with minimal reported adverse effects 6, 3
• No serious adverse events have been reported in clinical trials

Key Limitations

• Lack of standardized treatment protocols
• Variable results across different devices and treatment parameters 3
• Limited long-term efficacy data
• Not FDA-approved for ED treatment in the United States
• May not be covered by insurance

Conclusion

While Li-ESWT shows promise as a non-invasive treatment option for ED, particularly for patients with mild vasculogenic ED and those who don't respond to PDE5 inhibitors, its clinical benefits are modest. The EAU guidelines provide only a weak recommendation for its use. Patients should be counseled about the limited efficacy, lack of standardized protocols, and the availability of other more established treatment options with stronger evidence supporting their use.