Shockwave therapy (Li-ESWT)
Sold as a cure, priced like surgery, backed by evidence that isn't there yet
Our overall score
Written by J. Porter, MPH
Medically reviewed by A. Vance, MD
Last reviewed
The short version
Low-intensity shockwave therapy is marketed as the treatment that fixes the cause of ED rather than masking it — a course of acoustic-wave sessions that supposedly regrows blood vessels. The theory is genuinely interesting and the procedure appears to be safe. What it is not is proven. No device is FDA-cleared to treat ED in the US, the AUA considers it investigational, and clinics charge thousands of dollars up front for it anyway.
Our verdict: Not ready. The safety record is reassuring and the mechanism is plausible, but the trials are small, short, inconsistent, and often funded by people selling the machines. Paying $3,000–$6,000 out of pocket for that is a bad trade when generic tadalafil costs a few dollars a month and actually works.
Best for: Almost nobody, yet. If you try it, do so understanding you are paying to be an early adopter of an unproven treatment.
What works
- Appears safe — the reported adverse event rate across trials is very low
- No drugs, so no interactions and nothing to take before sex
- The proposed mechanism is restorative rather than symptomatic, which would be genuinely new if proven
- Painless, needs no anaesthetic, and requires no recovery time
What to watch
- No device is FDA-cleared to treat ED — clinics use machines approved for something else
- AUA guidance classifies it as investigational, not as a standard treatment
- Costs thousands of dollars, entirely out of pocket, usually charged before you know if it works
- Trials are small and heterogeneous, and many are funded by device manufacturers
- Durability is unclear — benefit appears to fade, and repeat courses cost again
- Marketing routinely overstates the evidence, including the meaning of 'FDA-cleared'
At a glance
- How it works
- A handheld probe delivers low-intensity acoustic waves to the shaft and crura over several sessions. The proposed mechanism is angiogenesis — micro-stress prompting the growth of new blood vessels and improving endothelial function.
- Time to effect
- Weeks to months after a completed course, if it works at all
- How you get it
- Administered in a clinic, typically 6–12 sessions over several weeks
- Regulatory status
- No device is FDA-approved or cleared to treat erectile dysfunction in the US. Clinics use devices cleared for other indications, off-label
- Typical cost
- Commonly $3,000–$6,000 for a course, paid out of pocket
- Ongoing cost
- Benefit appears to wane; repeat courses are often recommended and re-charged
- Clinical standing
- Considered investigational in AUA guidance — recommended only in the context of clinical trials or with explicit informed consent about the limited evidence
The pitch, and why it is appealing
Every other treatment on this site manages a symptom. A pill helps you get an erection tonight; a vacuum device produces one mechanically. None of them changes the underlying blood vessels.
Low-intensity extracorporeal shockwave therapy — Li-ESWT — claims to do exactly that. The idea is that controlled acoustic waves create micro-stress in penile tissue, which triggers angiogenesis: the growth of new blood vessels and improvement of the endothelial lining. Fix the plumbing, the argument goes, and you stop needing the pills.
That would be a genuine advance. It is also exactly the kind of claim that should make you want to see the evidence before writing a cheque.
What the evidence actually shows
There is a real signal here — this is not homeopathy. Multiple randomised trials and several meta-analyses have found statistically significant improvement in erectile function scores after a course of Li-ESWT, compared with sham treatment.
The problem is everything around that sentence.
| Issue | Why it matters |
|---|---|
| Small samples | Most trials enrol dozens of participants, not hundreds. Small trials overstate effect sizes. |
| Inconsistent protocols | Energy levels, number of sessions, pulse counts, and treatment sites vary widely between studies. There is no agreed protocol, so it is unclear what is even being compared. |
| Short follow-up | Many studies stop at three to six months. A restorative treatment should be judged on whether it lasts years. |
| Modest effect size | Improvements in questionnaire scores are often small enough that whether patients would notice is genuinely arguable. |
| Industry funding | A substantial share of the literature involves people who sell the machines. That does not make it wrong, but it warrants scepticism. |
| Publication bias | Positive results in a commercially hot area get published. Null results often do not. |
The regulatory sleight of hand
This is the part that most affects whether you are being told the truth in a consultation.
Off-label use is legal and often legitimate; doctors do it constantly with good reason. But there is a difference between a clinician exercising judgement about an individual patient and a clinic building a cash-pay business line on an indication the device was never assessed for, then advertising the clearance as if it endorsed that use.
Ask directly: is this device cleared by the FDA specifically to treat erectile dysfunction? The honest answer is no. How the person in front of you handles that question tells you a great deal.
What it costs, and how it is sold
A course typically runs six to twelve sessions and commonly costs somewhere in the region of three to six thousand dollars. Insurance does not cover it, because it is not an established treatment.
The sales structure deserves attention on its own. Courses are usually sold as a package and paid for before you know whether it works. If it doesn't, the recommendation is frequently a maintenance course — billed again. A treatment whose benefit is uncertain and whose durability is unknown, sold as a prepaid multi-session package, puts essentially all of the risk on the patient.
Marketing claims to distrust
- “Cures” or “reverses” ED — no treatment in this category has demonstrated that
- “Permanent results” — durability beyond a year is one of the biggest open questions
- “Clinically proven” — the literature does not support this phrase at the strength it implies
- “FDA-cleared” without naming the indication — see above
- “No more pills, ever” — trial participants frequently remain on PDE5 inhibitors
- Pressure to buy a package today, or a discount that expires — a legitimate medical treatment is not sold this way
- Before-and-after testimonials in place of trial data
At-home shockwave devices
Consumer devices sold online promising the same effect are a separate matter, and a worse one. They generally deliver far lower energy than clinical equipment, follow no validated protocol, and have no trial evidence at all. Whatever uncertainty attaches to clinic-administered Li-ESWT, the at-home versions do not inherit its evidence — they inherit only its marketing.
If you are going to try it anyway
That is a legitimate choice. It appears to be safe, and some people reasonably prefer to spend money on a possibility than take a pill indefinitely. If you do:
- 1Get evaluated first. Make sure the ED has actually been worked up — see why new ED warrants a cardiovascular check. Shockwave for undiagnosed diabetes is money spent avoiding the diagnosis.
- 2Try the cheap thing first. If you have not given a PDE5 inhibitor a fair trial at a proper dose, do that before spending thousands.
- 3Ask what device and protocol they use, and how it compares to the ones in published trials.
- 4Refuse to prepay a full course. Pay per session if you possibly can.
- 5Get the claimed success rate in writing, and ask what study it comes from.
- 6Agree in advance what failure looks like and what happens then — specifically, whether the answer is another paid course.
- 7Ask whether the clinician has any financial interest in the device or the clinic.
Our position
We are not saying shockwave therapy does not work. We are saying nobody currently knows whether it works well enough, for whom, or for how long — and that the gap between what the evidence supports and what clinics advertise is the widest of any treatment covered on this site.
If the larger, longer, independently funded trials come in positive, this page will change. Until they do, a treatment costing thousands of dollars with investigational status is not something we can recommend over options that are proven, cheap, and available now.
Common questions
Does shockwave therapy for ED actually work?
Trials show a statistically significant but modest improvement in erectile function scores versus sham treatment, mostly in men with mild-to-moderate vascular ED. The studies are small, use inconsistent protocols, follow patients only briefly, and are often industry-funded. So: possibly, for some people, to an uncertain degree, for an unknown length of time.
Is shockwave therapy FDA-approved for erectile dysfunction?
No. No device is FDA-approved or cleared specifically to treat ED in the US. Clinics use devices cleared for other indications and apply them off-label. When a clinic advertises an “FDA-cleared” device, ask what indication it was cleared for.
How much does it cost?
Commonly $3,000–$6,000 for a course of six to twelve sessions, paid out of pocket. Insurance does not cover it because it is not an established treatment. Packages are usually sold up front, before you know whether it works for you.
Is it safe?
This is the strongest part of its case. Reported adverse events across published trials are rare and minor, and the procedure needs no anaesthetic or recovery time. The concern with shockwave therapy is cost and uncertain benefit, not harm.
How long do the results last?
Nobody reliably knows. Most trials stop at three to six months. Such benefit as exists appears to fade over time, which is why maintenance courses are commonly recommended — and billed again.
What about GAINSWave?
GAINSWave is a marketing brand and provider network rather than a specific device or a distinct treatment. Being part of a branded network says nothing about the underlying evidence, which is the same investigational Li-ESWT literature discussed here.
Are at-home shockwave devices worth trying?
No. They typically deliver far less energy than clinical equipment, follow no validated protocol, and have no supporting trial evidence. They borrow the marketing of clinical Li-ESWT without inheriting even its limited evidence base.
Sources
- 1.Erectile Dysfunction: AUA Guideline — American Urological Association
- 2.Treatment for Erectile Dysfunction — National Institute of Diabetes and Digestive and Kidney Diseases (NIH)
- 3.Device approvals, denials and clearances — U.S. Food and Drug Administration