Shockwave Therapy for ED: Does Low-Intensity Extracorporeal Shockwave Therapy Work?

What Is Low-Intensity Shockwave Therapy?

Low-intensity extracorporeal shockwave therapy (LiESWT) delivers acoustic pressure waves (0.09-0.25 mJ/mm2) to penile tissue. These are the same type of shockwaves used in lithotripsy (kidney stone treatment) but at much lower energy levels. The mechanical stimulus triggers biological responses in the tissue: release of growth factors (VEGF, eNOS), recruitment of stem cells, and stimulation of new blood vessel formation (angiogenesis) [1].

The concept is straightforward. Vasculogenic ED (the most common type) results from insufficient blood flow to the penis due to endothelial dysfunction and atherosclerosis. If shockwaves can stimulate new blood vessel growth and improve endothelial function in penile tissue, they could restore erectile capacity at a fundamental level rather than temporarily enhancing it with medication.

This is what makes LiESWT different from every other ED treatment. PDE5 inhibitors (Viagra, Cialis) enhance the existing vascular response. Injections (alprostadil, trimix) bypass the natural erectile mechanism entirely. Vacuum devices and implants are mechanical solutions. LiESWT is the only approach that attempts to reverse the underlying vascular damage.

What the Clinical Evidence Shows

The Positive Studies

Multiple randomized controlled trials and meta-analyses support LiESWT efficacy for ED:

• A 2017 meta-analysis by Lu et al. analyzing 7 RCTs (602 participants) found that LiESWT significantly improved IIEF (International Index of Erectile Function) scores compared to sham treatment, with a mean difference of 2.00 points [2].
• A 2019 meta-analysis by Clavijo et al. confirmed clinically meaningful improvements in erectile function scores, with the largest effects seen in men with mild-to-moderate vasculogenic ED [3].
• Vardi et al.’s original 2012 RCT demonstrated that LiESWT improved penile hemodynamics (measured by peak systolic velocity on duplex ultrasound) and enabled men who were PDE5 inhibitor non-responders to respond to medication [4].

The Limitations

The evidence is promising but not yet definitive:

• Small sample sizes: Most trials enrolled 50-100 men. No large-scale trial (500+ participants) has been published.
• Variable protocols: Studies differ in energy levels, number of shockwaves per session, number of sessions, treatment frequency, and device type. This makes cross-study comparison difficult and means we do not know the optimal protocol.
• Sham control challenges: True blinding is difficult because patients can feel the shockwaves. Some sham protocols may not fully blind participants.
• Durability questions: Most studies report outcomes at 1-6 months. Limited data beyond 12 months. Some studies show effects waning at 12 months, suggesting the need for repeat treatment cycles.
• Publication bias: Positive studies are more likely to be published. The full picture may be less favorable than published data suggests.

What the Guidelines Say

The European Association of Urology (EAU) guidelines include LiESWT as an option with a “weak recommendation” based on limited evidence quality. The American Urological Association (AUA) considers it investigational and does not yet include it in standard guidelines. The Sexual Medicine Society of North America supports its use in clinical practice for men with vasculogenic ED based on the aggregate evidence [5].

Who Benefits Most

LiESWT works best for a specific patient profile:

• Mild-to-moderate vasculogenic ED: Men who can still achieve partial erections but lack the firmness or duration for satisfactory intercourse. These men have enough residual vascular capacity that stimulating new vessel growth can make a clinically meaningful difference.
• PDE5 inhibitor partial responders: Men who respond to Viagra or Cialis but want to reduce dependence or improve their baseline function. LiESWT can convert partial responders into fuller responders.
• PDE5 inhibitor non-responders: Some studies show LiESWT can restore PDE5 inhibitor responsiveness in men who had stopped responding, presumably by improving the vascular substrate that PDE5 inhibitors require to work.

Men with severe ED from advanced vascular disease, post-prostatectomy nerve damage, or Peyronie’s disease with severe fibrosis are less likely to benefit. LiESWT cannot regenerate tissue that is extensively damaged or create new nerve connections.

The Treatment Experience

What a Session Looks Like

A typical LiESWT session involves:

1. The provider applies ultrasound gel to the penis
2. A handheld device delivers 3,000-5,000 shockwave pulses to 4-5 treatment zones (both corpora cavernosa, the crura, and sometimes the perineum)
3. Each session takes 15-20 minutes
4. No anesthesia is needed. Most patients describe the sensation as mild tapping or tingling. Occasionally mildly uncomfortable but not painful.
5. No downtime. Normal activities (including sexual activity) can resume immediately.

Typical Protocol

Most clinical protocols follow one of two schedules:

• 6-session protocol: 2 sessions per week for 3 weeks, then a 3-week rest period, then another 2 sessions per week for 3 weeks (12 sessions total). This was used in Vardi’s original trial.
• 6-week protocol: 1-2 sessions per week for 6 consecutive weeks (6-12 sessions total). Used in several recent trials.

Results typically take 1-3 months to fully develop, as neovascularization and tissue remodeling are gradual biological processes.

Devices

Several devices are used clinically, differing in shockwave generation mechanism:

• Focused shockwave devices: Deliver energy to a precise focal zone deep within tissue. Used in most published RCTs.
• Radial (unfocused) devices: Distribute energy broadly across the tissue surface. Less expensive, more widely available, but fewer published studies supporting their use for ED.
• Home devices: Consumer-marketed devices claiming to deliver LiESWT at home. The energy levels and tissue penetration of these devices have not been validated against clinical devices. Approach with caution.

Cost and Practical Considerations

LiESWT for ED is not covered by insurance in the United States. Out-of-pocket costs range from $400-$600 per session, with typical total costs of $2,500-$6,000 for a complete treatment course.

When evaluating providers, consider:

• Are they using a device with published clinical evidence (focused shockwave devices used in RCTs)?
• Do they perform a vascular evaluation (duplex ultrasound) before treatment to confirm vasculogenic ED?
• Is the provider a urologist or sexual medicine specialist, or is this a cash-pay clinic with no specialist oversight?
• Do they discuss realistic expectations, including the limitations of current evidence?
• Do they offer combination approaches (LiESWT with PDE5 inhibitors, with or without PRP) when appropriate?

Combination Therapies

Emerging approaches combine LiESWT with other regenerative modalities:

• LiESWT + PRP: Platelet-rich plasma injected into the penis after shockwave treatment. The theory is that shockwaves create a receptive tissue environment, and PRP provides concentrated growth factors to amplify the regenerative response. Small case series show promising results, but controlled data is limited.
• LiESWT + PDE5 inhibitors: Using daily low-dose tadalafil (5 mg) during and after the LiESWT treatment course to maintain vasodilation while new vessels develop. Some studies suggest this combination outperforms either treatment alone.
• LiESWT + stem cells: Very early investigation. No controlled data in humans for ED specifically.

Related Reading

• Erectile Dysfunction: The Evidence-Based Guide (Pillar)
• Erectile Dysfunction and Heart Health: The Cardiovascular Connection
• Testosterone Replacement Therapy: The Evidence-Based Guide

References

1. Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy: a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012;9(1):259-264. doi:10.1111/j.1743-6109.2011.02498.x
2. Lu Z, Lin G, Reed-Maldonado A, et al. Low-intensity extracorporeal shock wave treatment improves erectile function: a systematic review and meta-analysis. Eur Urol. 2017;71(2):223-233. doi:10.1016/j.eururo.2016.05.050
3. Clavijo RI, Stember DS, Castello ER, Perelman MA. Update: complications and management of penile shockwave therapy. Curr Urol Rep. 2019;20(11):73. doi:10.1007/s11934-019-0939-1
4. Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012;187(5):1769-1775. doi:10.1016/j.juro.2011.12.117
5. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. J Urol. 2018;200(3):633-641. doi:10.1016/j.juro.2018.05.004