GAINSWave Therapy for ED: How Shockwave Treatment Works and What the Evidence Shows

GAINSWave therapy is a branded protocol of low-intensity extracorporeal shockwave therapy (Li-ESWT, also called low-intensity shockwave therapy or LiSWT) for erectile dysfunction, in which a provider applies acoustic pulses to the penis over a course of typically 6 to 12 short sessions to stimulate new blood vessel growth. A 2017 meta-analysis of 7 randomized trials with 602 men, by Clavijo and colleagues in the Journal of Sexual Medicine, found larger gains in erectile function scores than sham treatment, mostly in mild to moderate vasculogenic ED, while the American Urological Association (2018) still classifies Li-ESWT for ED as investigational.

Erectile dysfunction affects an estimated 30 million men in the United States, and the prevalence increases with age. For decades, the treatment playbook has been straightforward: PDE5 inhibitors like Viagra (sildenafil) and Cialis (tadalafil), intracavernosal injection therapy, vacuum erection devices, or penile implant surgery. These options work, but they share the same limitation. They manage the symptom without addressing the underlying vascular damage that causes most ED in the first place.

GAINSWave is a branded treatment protocol that uses low-intensity extracorporeal shockwave therapy (Li-ESWT) to target that root cause. The concept: deliver acoustic energy to penile tissue, trigger the formation of new blood vessels, and restore the blood flow that erections depend on. It has generated significant patient interest, heavy marketing, and a growing but mixed body of clinical evidence.

Li-ESWT belongs to a group of so-called restorative therapies for ED, alongside platelet-rich plasma (PRP) and intracavernosal stem cell injections. The American Urological Association (2018) labels shockwave therapy and stem cell therapy for ED investigational and PRP experimental, so all three are offered mainly as cash pay services outside standard care.

What Is GAINSWave?

GAINSWave is not a device or a technology. It is a treatment protocol and provider network built around Li-ESWT for ED. Providers in the network use focused, linear or radial shockwave devices from several manufacturers and follow a standardized protocol: typically 6 to 12 sessions, each lasting 15 to 20 minutes, performed twice weekly over 3 to 6 weeks [1].

The underlying technology, Li-ESWT, has been used in medicine for over 30 years. Urologists originally adapted it from the lithotripsy devices used to break up kidney stones. The key difference is intensity: lithotripsy uses high-energy shockwaves to shatter calcified stones, while Li-ESWT uses much lower energy to stimulate biological repair in soft tissue [2]. The same family of technology is used for plantar fasciitis, tendon pain and other musculoskeletal conditions, covered in the shockwave therapy treatment guide.

Is GAINSWave a Li-ESWT Device?

GAINSWave is a Li-ESWT protocol, not a Li-ESWT device. The brand licenses a treatment schedule, training and marketing to clinics, and each clinic chooses the machine it uses. That means two clinics offering "GAINSWave" can deliver different energy types, energy levels and pulse counts.

The difference matters because the research behind Li-ESWT for ED was done mostly with focused or linear devices. In the Clavijo meta-analysis, six of the seven included randomized trials used the same focused electromagnetic device type [9]. Radial pressure wave devices, often marketed as acoustic wave therapy, spread energy over a shallower area, and they have far fewer sham-controlled ED trials behind them.

Device type	How the energy travels	Evidence for ED
Focused shockwave (Li-ESWT)	Concentrated at a set depth in the tissue	Most sham-controlled RCTs and meta-analyses
Linear shockwave	Focused along a line that covers the shaft	Several RCTs, with mixed results
Radial pressure wave (acoustic wave)	Spreads outward from the skin and weakens with depth	Limited, few sham-controlled ED trials

A practical question to ask any clinic is which device type it uses, what energy density it delivers, and how many pulses each session includes. A well run clinic answers those questions plainly.

How Li-ESWT Works for ED

Vasculogenic ED, which accounts for roughly 70 to 80% of all ED cases, results from impaired blood flow to the penis. The smooth muscle and blood vessels in the corpora cavernosa degrade over time due to atherosclerosis, diabetes, hypertension, and other vascular risk factors. Erections require rapid arterial inflow and effective venous trapping, and when the vascular hardware is compromised, that hydraulic process fails [3]. The link between ED and cardiovascular risk is covered in more depth on the erectile dysfunction condition page.

Li-ESWT addresses this through several biological mechanisms:

• Angiogenesis. Shockwaves trigger the release of vascular endothelial growth factor (VEGF) and other angiogenic factors, stimulating the formation of new blood vessels in the treated tissue [2][4].
• Nitric oxide pathway activation. Li-ESWT upregulates endothelial nitric oxide synthase (eNOS), which increases nitric oxide production. Nitric oxide is the primary chemical signal that relaxes smooth muscle and allows blood to fill the penis during arousal [4].
• Stem cell recruitment. Shockwave energy appears to recruit progenitor cells to the treated area, contributing to tissue repair and regeneration [2].
• Nerve regeneration. Animal studies suggest Li-ESWT may support the regrowth of cavernous nerve fibers damaged by diabetes or surgery [5].

In short, Li-ESWT aims to rebuild the vascular and neural infrastructure that erections depend on, rather than temporarily boosting blood flow the way a PDE5 inhibitor does. Most of the mechanism data comes from animal and laboratory studies, so the human benefit is judged by the clinical trials below.

What the Clinical Evidence Shows

Randomized Controlled Trials

Vardi and colleagues first reported Li-ESWT for ED in a 2010 pilot study with 6-month follow-up [1]. Their sham-controlled randomized trial followed in the Journal of Urology in 2012: 67 men with vasculogenic ED were randomized 2:1 to 12 sessions of Li-ESWT or sham (2 sessions per week for 3 weeks, a 3-week break, then another 3 weeks of treatment). The treatment group showed a statistically significant improvement in erectile function scores (IIEF-EF) and in measured penile blood flow compared to sham at 1 month post-treatment [10].

A sham-controlled trial by Kitrey and colleagues (2016) tested the treatment in a harder group: men who did not respond to PDE5 inhibitors. Active shockwave treatment shifted a share of these non-responders into responders on medication, an effect not seen with sham [6].

Not every trial is positive. A double-blind trial of linear Li-ESWT by Fojecki and colleagues (2017) in 126 men found no difference in success rates between active and sham treatment [11]. Negative results like this one are part of why guideline bodies still disagree.

Meta-Analyses

A 2017 meta-analysis by Clavijo and colleagues, published in the Journal of Sexual Medicine, pooled data from 7 RCTs involving 602 patients. Men treated with Li-ESWT improved by 6.40 points on the IIEF-EF score versus 1.65 points with sham, a statistically significant difference, although results varied widely between trials [9]. A 2019 meta-analysis by Dong and colleagues in the American Journal of Men's Health reached a similar conclusion, with the clearest benefit in men with mild to moderate ED [7].

A 2021 systematic review pointed the same way, describing short-term benefit for vasculogenic ED and a favorable safety record, while also flagging the need for larger trials with longer follow-up and standardized protocols [8].

What Guidelines Say

The American Urological Association ED guideline (Burnett and colleagues, 2018) states that Li-ESWT for ED should be considered investigational, a conditional recommendation based on Grade C evidence [12]. The European Association of Urology guidelines take a more favorable view and support Li-ESWT for selected men with mild vasculogenic ED or a partial response to PDE5 inhibitors. The Sexual Medicine Society of North America has described shockwave therapy as relatively safe while noting that robust clinical trials are still lacking.

Who Responds Best

The evidence consistently points to the same patient profile for best results:

• Mild to moderate vasculogenic ED (not severe or neurogenic)
• Men who respond to PDE5 inhibitors (suggesting the vascular hardware is damaged but still partially functional)
• Men without severe penile fibrosis (Peyronie’s disease complicates the picture)
• Non-smokers or former smokers (active smoking impairs vascular response)

Men with severe ED, complete PDE5 inhibitor failure, or neurogenic causes (spinal cord injury, radical prostatectomy with bilateral nerve damage) are less likely to respond, though some studies show partial improvement even in these populations [6].

Does GAINSWave Work for ED?

GAINSWave can improve erections for some men, mainly those with mild to moderate vasculogenic ED, because the Li-ESWT it is built on outperformed sham treatment in pooled randomized trials [9]. The average gain is modest, results vary from one trial to the next, and a minority of trials found no benefit at all [11].

Whether a specific GAINSWave course works also depends on the device a clinic uses and the dose it delivers, since most positive trials used focused shockwave devices. Men with severe ED, nerve damage after prostate surgery, or ED that is mainly psychological are the least likely to benefit, and for them established options such as PDE5 inhibitors, injections or a penile implant remain the standard of care.

Is GAINSWave FDA Approved?

No shockwave device is FDA approved specifically for treating erectile dysfunction, so GAINSWave and other Li-ESWT protocols for ED are offered outside an FDA-approved indication. The FDA-approved first-line drugs for ED are the PDE5 inhibitors sildenafil, tadalafil, vardenafil and avanafil, which the AUA guideline recommends discussing with every man who has ED unless they are contraindicated [12].

Because of that regulatory status and the AUA's investigational label, US insurers generally treat Li-ESWT for ED as elective. It is usually provided by urologists, men's health physicians and sexual medicine clinics, and sometimes by clinics run by other licensed clinicians under physician oversight.

GAINSWave vs. PDE5 Inhibitors

Factor	GAINSWave (Li-ESWT)	PDE5 Inhibitors (Viagra, Cialis)
Mechanism	Structural repair (new blood vessels, tissue regeneration)	Temporary blood flow enhancement (blocks PDE5 enzyme)
Onset	Gradual over 1 to 3 months	30 to 60 minutes per dose
Duration	Months to years (evidence suggests 1 to 2 years)	4 to 36 hours per dose
Side effects	Minimal (mild bruising, temporary soreness)	Headache, flushing, nasal congestion, vision changes
Cost	$3,000 to $7,000 (full course)	$30 to $70/month (generic)
Daily medication	None	Required for effect
Evidence level	Moderate (7+ RCTs, meta-analyses)	Very strong (decades of large-scale trials)

The two approaches are not mutually exclusive. Many patients use Li-ESWT to improve baseline erectile function and then need lower doses of PDE5 inhibitors, or stop needing them altogether. Some protocols explicitly combine both, using shockwave therapy to restore vascular capacity and PDE5 inhibitors as-needed during the recovery period [1]. A wider side-by-side of pills, injections, devices and regenerative options is in the ED treatment guide.

The Treatment Protocol

What a Session Looks Like

Each session takes 15 to 20 minutes. You lie on an exam table, and the provider applies a handheld device to the shaft and base of the penis (and sometimes the perineum). The device delivers thousands of low-energy acoustic pulses per session. Most patients describe the sensation as a tapping or mild vibration. No anesthesia is required. There is no downtime: you can return to normal activities, including sexual activity, immediately [1].

Standard Protocol

• Sessions: 6 to 12 total
• Frequency: 2 sessions per week
• Duration: 3 to 6 weeks for the full course
• Some protocols include a 3-week break midway (the Vardi protocol: 3 weeks on, 3 weeks off, 3 weeks on)

Results typically become noticeable 1 to 3 months after completing the full treatment course, as the new blood vessels and tissue remodeling take time to mature.

What Happens Before the First Session

A careful clinic starts with a medical history, a review of current medications, and a validated questionnaire such as the IIEF or the Erection Hardness Score to record a baseline. Because ED can be an early sign of heart disease, diabetes or low testosterone, many urologists also check blood pressure, blood sugar, lipids and testosterone before recommending any restorative therapy. Some use penile Doppler ultrasound to confirm that the ED is vascular.

Cost

GAINSWave is not covered by insurance. Out-of-pocket costs vary by provider and geographic area:

• Per session: $500 to $700
• 6-session course: $3,000 to $4,200
• 12-session course: $5,000 to $7,000
• Maintenance sessions (if needed): $500 to $700 every 12 to 18 months

Some clinics offer package discounts. A few offer financing. Compare this to the ongoing cost of PDE5 inhibitors ($30 to $70/month for generics, or $360 to $840/year), and the shockwave route becomes cost-competitive over a 3- to 5-year horizon if it reduces or eliminates the need for daily medication.

Prices are set clinic by clinic, so ask for the total course price, the device type and the number of pulses per session in writing before you pay. Clinic profiles in the shockwave therapy clinic directory let you compare providers in your state before you call.

Safety and Side Effects

Li-ESWT has an excellent safety profile across all published studies. The most common side effects are mild and temporary:

• Mild bruising or redness at the treatment site
• Temporary numbness or tingling
• Minor discomfort during the session

No serious adverse events have been reported in any of the published RCTs [7][8]. The treatment does not require sedation, does not involve needles, and does not cause systemic side effects.

Who Should Not Have Li-ESWT

Randomized trials commonly excluded men taking anticoagulants other than low-dose aspirin, men with a penile prosthesis, and men with anatomical disorders of the penis [9]. Clinics also tend to avoid treating over an active infection or a known cancer in the pelvic area. If you take a blood thinner or have a bleeding disorder, raise it with the treating clinician before the first session.

Who Should Consider GAINSWave

Good candidates:

• Men with mild to moderate vasculogenic ED
• Men who respond to Viagra or Cialis but want to reduce dependence on medication
• Men who experience side effects from PDE5 inhibitors
• Men seeking a non-pharmaceutical, non-surgical option
• Men interested in performance optimization (some protocols target men without clinical ED)

Less likely to benefit:

• Men with severe ED and complete PDE5 inhibitor failure
• Men with neurogenic ED from spinal cord injury
• Men with significant Peyronie’s disease (though shockwave is also studied for this separately)
• Men whose ED is primarily psychological rather than vascular

The evidence for treating men without clinical ED is thin: the randomized trials enrolled men with diagnosed ED, so performance claims for healthy men rest on marketing rather than published data.

How to Find a GAINSWave or Li-ESWT Provider

Li-ESWT for ED is offered by urology practices, men's health clinics and regenerative medicine clinics, and the training and oversight behind it vary. A urologist or sexual medicine specialist can also rule out causes of ED that shockwave therapy does not address, such as low testosterone, medication side effects or nerve damage.

1. Confirm who evaluates you: a licensed physician, ideally a urologist, should review your history and baseline tests.
2. Ask which device type the clinic uses (focused, linear or radial) and how its protocol compares with the trials.
3. Get the full course price, the number of sessions and any maintenance plan in writing.
4. Ask how the clinic measures results, such as a repeat IIEF score at 1 and 3 months.

The national ED treatment clinic list shows clinics that offer shockwave therapy alongside other erectile dysfunction services. Listing order on Regenerated.com is not paid ranking, Featured slots are labeled and capped, and Verified means credential checks, not spend, as explained in how Featured, Verified and organic listings differ. Regenerated.com is free for patients, and inclusion in the directory is not an endorsement.

Frequently asked questions

Does GAINSWave work?

GAINSWave can work for some men with mild to moderate vasculogenic ED. The Li-ESWT it is based on improved erectile function scores more than sham treatment in a 2017 meta-analysis of 7 randomized trials with 602 men by Clavijo and colleagues. The average gain is modest, some trials found no benefit, and the American Urological Association (2018) still classifies the treatment as investigational. Men with severe or nerve-related ED are the least likely to respond.

Is GAINSWave a Li-ESWT device?

GAINSWave is not a device. It is a branded Li-ESWT treatment protocol and provider network, and each participating clinic chooses its own shockwave machine. Some clinics use focused or linear shockwave devices like those tested in most randomized trials, while others use radial pressure wave devices, often called acoustic wave therapy, which have less ED research behind them. Asking which device and energy level a clinic uses is a reasonable first question.

Is GAINSWave FDA approved for ED?

GAINSWave is not FDA approved for erectile dysfunction, because no shockwave device has an FDA approval for that use. Clinics offer it as an elective, cash pay service. The FDA-approved first-line treatments for ED are PDE5 inhibitors such as sildenafil and tadalafil. The American Urological Association guideline (2018) labels low-intensity shockwave therapy for ED investigational, while European urology guidelines support it for selected men with mild vasculogenic ED.

How many GAINSWave sessions do you need?

A typical GAINSWave course is 6 to 12 sessions of 15 to 20 minutes, given about twice a week over 3 to 6 weeks. Some protocols follow the Vardi schedule of 3 weeks on, 3 weeks off and 3 weeks on. Any improvement usually appears 1 to 3 months after the last session, and some clinics suggest maintenance sessions every 12 to 18 months, although trials have not settled how often, or whether, they are needed.

Does insurance cover GAINSWave therapy?

Insurance does not cover GAINSWave therapy, because US insurers generally treat shockwave therapy for ED as an elective service that is not FDA approved for that use. Typical out-of-pocket prices run $500 to $700 per session and $3,000 to $7,000 for a full course. Some clinics offer package pricing or financing, so ask for the total course price in writing and compare it with the ongoing cost of generic PDE5 inhibitors.

Does GAINSWave hurt?

GAINSWave sessions are usually not painful. Most men describe a tapping or mild vibrating feeling on the shaft and base of the penis, and no anesthesia or needles are involved. Published trials report mainly mild, temporary effects such as redness, bruising, tingling or brief soreness, with no serious adverse events. Most men return to normal activities, including sex, the same day.

The Bottom Line

GAINSWave is a branded protocol for Li-ESWT, a treatment with real science behind it. The clinical evidence from multiple RCTs and meta-analyses supports that low-intensity shockwave therapy produces measurable improvements in erectile function, particularly for men with mild to moderate vasculogenic ED. It works through a fundamentally different mechanism than PDE5 inhibitors, targeting structural repair rather than temporary symptom management.

The limitations: it costs thousands of dollars out-of-pocket, the long-term data is still limited, US guidelines still call it investigational, and it does not work for everyone. But for men who want to address the underlying vascular cause of their ED rather than taking a pill every time, it is one of the more evidence-supported options available today. For a broader look at shockwave applications, see our shockwave therapy guide. For the full picture on ED treatments, see our erectile dysfunction guide.

Related Reading

• Shockwave Therapy: The Complete Guide
• Erectile Dysfunction Guide
• PRP Therapy Guide
• Shockwave Therapy for ED
• Acoustic Wave Therapy

Sources

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