Shockwave Therapy for Erectile Dysfunction
Low-intensity shockwave therapy (LI-SWT) may be used in men with mild vasculogenic ED, though the evidence remains weak and benefits are modest. 1
Primary Recommendation Based on Current Guidelines
The 2025 European Association of Urology guidelines provide a weak recommendation for LI-SWT use specifically in men with mild vasculogenic ED. 1 This weak recommendation reflects the limited standardization of treatment protocols and modest clinical benefits that may not be perceived as significant by all patients. 1
When to Consider LI-SWT
LI-SWT stands out as the only marketed treatment potentially offering a cure for ED, distinguishing it from symptomatic treatments like PDE5 inhibitors. 1
Best Candidates:
- Men with mild vasculogenic ED who want a potentially disease-modifying treatment 1
- PDE5 inhibitor non-responders, where LI-SWT has shown particular benefit 1, 2, 3
- Patients seeking treatment that addresses underlying pathology rather than on-demand symptom management 4
Expected Outcomes and Efficacy
Magnitude of Benefit:
- Mean IIEF-EF improvement of approximately 4 points in pooled RCT data 1
- Effects diminish over time but remain detectable up to 5 years in some cases 1
- In PDE5i non-responders specifically, studies show mean IIEF-EF increases of 8.6 points when LI-SWT is combined with continued PDE5i use 2
Response Rates:
- 60-78% of patients achieve clinically meaningful improvement in studies of PDE5i non-responders 2, 4, 3
- 67.9% achieve erections sufficient for intercourse (EHS ≥3) after treatment 2
- Response rates maintained at 12 months in 91.7% of initial responders 3
Combination Therapy Approach
LI-SWT shows enhanced results when combined with other ED treatments, suggesting multimodal approaches may be superior to monotherapy. 1
Evidence-Based Combinations:
- LI-SWT + daily tadalafil demonstrates improved outcomes 1
- LI-SWT + vacuum erection devices shows enhanced results 1
- LI-SWT + continued PDE5i use in non-responders produces significant improvements 2, 3
Treatment Protocol Considerations
Critical Limitation:
A standardized treatment protocol is still lacking, which weakens the overall evidence base. 1 Different studies use varying protocols:
- Some protocols: 3000 shocks at 0.25 mJ/mm² twice weekly for 3 weeks 2
- Other protocols: 12 sessions total with different energy levels 4
- Alternative protocols: 6600 shocks per session for 6 consecutive weeks 5
- Yet another approach: 8 weekly sessions with either 3000 shocks at 0.09 mJ/mm² or 10,000 shocks at 90 mJ 6
Despite protocol variations, efficacy appears independent of generator type, shockwave source, or morphology. 6
Safety Profile
LI-SWT demonstrates excellent safety with no serious adverse events reported. 2, 4, 3, 5, 6
- Treatment is well-tolerated in outpatient settings 2
- Minimal discomfort reported, easily managed by device repositioning 5
- No treatment-related adverse events in multiple studies 2, 3
Common Pitfalls to Avoid
Critical Errors:
- Using LI-SWT in severe ED or non-vasculogenic ED where evidence is lacking 1
- Abandoning PDE5i therapy when combining with LI-SWT in non-responders—studies showing benefit maintained concurrent PDE5i use 2, 3
- Expecting immediate results—assessment should occur at 1-3 months post-treatment 4, 3, 5
- Declaring treatment failure without adequate follow-up—benefits may take time to manifest and can persist long-term 1, 3
Positioning in Treatment Algorithm
First-Line Therapy:
PDE5 inhibitors remain the recommended first-line treatment for ED unless contraindicated. 1 LI-SWT should not replace initial PDE5i trials.
When to Offer LI-SWT:
- After establishing PDE5i non-response with proper dosing, timing, and sexual stimulation education 1
- In mild vasculogenic ED confirmed by appropriate diagnostic testing 1
- As adjunctive therapy to enhance PDE5i effectiveness in partial responders 1, 2
- In motivated patients seeking disease-modifying rather than symptomatic treatment 1, 4
Hemodynamic Evidence
LI-SWT produces measurable improvements in penile hemodynamics:
- Significant increases in peak systolic velocity (PSV) from 27.79 to 41.66 cm/s 2
- Significant decreases in end-diastolic velocity (EDV) from 5.66 to 1.93 cm/s 2
- These vascular improvements correlate with clinical erectile function gains 2, 4
Quality of Life Impact
Beyond erectile function scores, LI-SWT improves sexual quality of life, with SQOL-M scores increasing from 45.56 to 55.31 (p<0.0001). 2 This suggests benefits extend beyond mechanical erectile improvement to overall sexual satisfaction and relationship quality.