GAINSWave is a brand name for a protocol that delivers low-intensity acoustic waves — often called shockwaves — to the penis through a handheld applicator. The treatment itself belongs to a broader category that clinicians call low-intensity extracorporeal shockwave therapy, or LI-ESWT. At Atlanta Medical Institute, it is one of several options we discuss with men who are dealing with erectile dysfunction, and it is performed in our office at 5009 Roswell Road NE in Buckhead.
We want to be direct with you about where this treatment stands. No shockwave device is FDA-approved for erectile dysfunction in the United States. Shockwave devices carry FDA clearance for other purposes, including certain wound-healing and musculoskeletal indications, but treating erectile dysfunction is not among them. The American Urological Association's erectile dysfunction guideline classifies low-intensity shockwave therapy as investigational, assigning it a Grade C evidence level, which reflects low or very low confidence in the size of the effect. The European Association of Urology took a somewhat more permissive position in its 2025 update on male sexual and reproductive health, saying the therapy may be offered to men with mild or moderate erectile dysfunction, on its own or alongside a PDE5 inhibitor — but as a weak recommendation.
So why do we offer it at all? Because for some men it is a reasonable thing to try. It is non-invasive, drug-free, does not interact with medications you already take, and generally requires no recovery time. For a man who cannot tolerate oral ED medication, who responds only partially to it, or who simply wants to avoid adding another pill, acoustic wave therapy is a low-risk option worth a conversation. What it is not is a proven replacement for established treatments, and we will not present it that way.
Whether GAINSWave is appropriate for you, and what a course of treatment would look like, is a decision one of our physicians makes after evaluating you. That evaluation matters for its own sake. Erectile dysfunction is frequently the first visible sign of a vascular problem, a hormone imbalance, poorly controlled diabetes, or a side effect of a medication you are already on — and some of those findings are far more important to your health than your erections are.
Program Benefits
- Non-invasive and performed in our office — no needles, incisions, or anesthesia
- Drug-free, so it does not add to your medication list or create new drug interactions
- Typically no downtime; most men go back to their usual routine the same day
- Eligibility and the treatment plan are decided by an AMI physician after an evaluation, not sold as a package beforehand
- Can be considered on its own or alongside other men's health treatments we offer
- An honest discussion of what the research supports and what it does not, before you spend anything
How Acoustic Wave Therapy Is Thought to Work
The proposed mechanism is vascular. Low-intensity acoustic waves are thought to trigger a mild, controlled tissue response that encourages the growth of small new blood vessels and improves blood flow through existing ones. Laboratory and animal research has supported parts of this idea, and it is the rationale behind using the therapy for erectile dysfunction that stems from poor circulation rather than from nerve damage or psychological causes.
It is worth knowing that human studies have not cleanly confirmed the blood-flow story. A 2025 systematic review and meta-analysis published in the World Journal of Men's Health, which pooled 12 randomized controlled trials, found statistically significant improvement in men's questionnaire scores for erectile function but no significant differences in penile Doppler ultrasound measurements — peak systolic velocity, end-diastolic velocity, or resistive index — between treated and control groups. In other words, men reported doing better, but the objective vascular measurements in those trials did not clearly change. Any clinic that describes the mechanism as settled science is overstating it.
You may also see marketing language claiming that acoustic waves break up plaque inside penile blood vessels. That description is a simplification and is not established in humans. We do not make that claim.
What the Evidence Actually Shows
The honest summary is that the evidence is genuinely mixed, and reasonable physicians disagree about it.
On the positive side, the 2025 World Journal of Men's Health meta-analysis found that men who received low-intensity shockwave therapy scored better on the International Index of Erectile Function than men who received a sham treatment or no treatment. That is a real, repeatable finding across multiple randomized trials, which is more than can be said for many treatments marketed to men.
On the cautionary side, the same analysis found no significant effect on erection hardness scores, on the Sexual Encounter Profile questions about successful intercourse, or on the Global Assessment Question, and its authors concluded that current evidence does not support routinely including the therapy in erectile dysfunction treatment algorithms. Follow-up in the pooled trials averaged only about 12 weeks, so durability beyond a few months is largely unstudied. Heterogeneity between studies was high, and recent reviews continue to note that there is still no agreed-upon standard protocol — the number of sessions, the energy setting, the pulse count, and the spacing of treatments all vary considerably from one study and one clinic to the next.
We share this not to talk you out of treatment, but because you deserve to weigh it with accurate information. This is a treatment that may help, not one that has been shown to reliably help.
Who Might Be a Candidate, and Who Probably Is Not
The men most often considered for acoustic wave therapy are those with mild to moderate erectile dysfunction that appears to be vascular in origin, and men who get a partial but incomplete response from oral ED medication. The European Association of Urology's 2025 guidance is framed around roughly that group.
Men whose erectile dysfunction has a different root cause are less likely to benefit, and we would rather tell you that at the consultation than after you have paid for a series. A physician evaluation at AMI looks for the things that actually drive the problem, including cardiovascular risk factors, blood sugar control, testosterone and other hormones, medications, sleep, alcohol use, and relationship or mood factors. Treating the underlying cause is often more productive than treating the symptom.
- More likely to be considered: mild to moderate erectile dysfunction, suspected vascular cause, partial response to oral medication, or a preference to avoid medication
- Less likely to benefit: severe erectile dysfunction, significant nerve injury including some post-prostatectomy cases, or primarily psychological causes
- May not be appropriate at all: active infection or skin breakdown in the treatment area, a bleeding disorder or certain blood-thinning medications, active cancer in the treatment area, or a penile implant
- Always evaluated first: testosterone level, cardiovascular risk, diabetes control, and current medication list
What a Course of Treatment Looks Like at AMI
Everything starts with a consultation. One of our physicians reviews your history, examines you, and orders any labs that are warranted. Only after that do we discuss whether acoustic wave therapy makes sense for you and what a course would involve. We do not sell treatment packages over the phone.
A session itself is straightforward. Ultrasound gel is applied, and a handheld applicator is moved over the treatment area while it delivers rapid low-intensity pulses. Sessions are short, generally on the order of 15 to 30 minutes, and are usually done in a series spread over several weeks. Most men describe a light tapping or mild buzzing sensation rather than pain, and anesthesia is typically not needed.
Session counts and energy settings vary, and as noted above, no standard protocol has been established in the literature. Your physician will recommend a plan based on your evaluation and will adjust it based on how you respond. Because this treatment is not FDA-approved for erectile dysfunction, insurance generally does not cover it; our staff will give you clear pricing before you commit to anything.
This is an in-office procedure. It is not something to attempt with a consumer device purchased online, and we would discourage that.
Safety, Monitoring, and Realistic Expectations
In published trials, low-intensity shockwave therapy has generally been well tolerated. Reported side effects have tended to be mild and short-lived — discomfort during the session, temporary redness or tenderness, occasionally minor bruising. Serious adverse events have been uncommon in the literature. That said, the same trials that limit our confidence in the benefits also limit long-term safety data, since most followed men for only a few months.
We monitor you through the course rather than simply running you through a fixed number of visits. Tell us about pain during or after a session, bruising, numbness, or any change in sensation, and we will adjust or stop. If you are not seeing meaningful change by the point in the series where we would expect it, we will say so and talk about other options instead of extending treatment indefinitely.
Please also hear this plainly: we cannot promise you a result. No one honestly can. Individual responses vary, averages from clinical trials are not predictions about you, and anyone offering a guaranteed or permanent outcome for erectile dysfunction is not being straight with you.
How GAINSWave Fits with Our Other Men's Health Services
Acoustic wave therapy is one tool, and it works best as part of a plan rather than as a standalone purchase. Our broader erectile dysfunction evaluation is described at /services/erectile-enhancement-ed, and the underlying modality is covered at /services/acoustic-sound-wave-therapy. Because low testosterone can contribute to both erectile difficulty and low desire, many men are also evaluated for it — see /services/low-testosterone-treatments.
Related conditions we treat include Peyronie's disease at /services/peyronies-disease and premature ejaculation at /services/premature-ejaculation. Some men are also candidates for regenerative approaches described at /services/stem-cells-exosomes-therapy, which your physician can discuss in context. Weight, blood sugar, and cardiovascular health have a real effect on erectile function as well, which is why our medical weight loss program at /services/weight-loss-atlanta-ga is sometimes part of the conversation.
Atlanta Medical Institute has served patients from a single Buckhead office since 2010. Dr. Leslye Pace, our Chief Medical Officer, focuses on regenerative medicine and pain, and you can read more about her at /about/dr-leslye-pace. To ask a question or schedule an evaluation, call (404) 264-9553 or reach us through /contact. Our hours are Monday through Thursday, 9 to 6, and Friday, 9 to 4.
Patient Reviews
"GAINSWave treatments were a game changer. Friendly staff, comfortable office, real results."
Frequently Asked Questions
Is GAINSWave FDA-approved for erectile dysfunction?+
No. No shockwave or acoustic wave device is FDA-approved to treat erectile dysfunction in the United States. Such devices have FDA clearance for other uses, including certain wound-healing and musculoskeletal indications, but not for ED. The American Urological Association's erectile dysfunction guideline currently classifies low-intensity shockwave therapy as investigational. We think you should know that before you decide.
Does the treatment hurt?+
Most men describe it as a light tapping or buzzing sensation rather than pain, and anesthesia is typically not used. Some tenderness or redness afterward is possible and usually resolves quickly. Tell your provider during the session if anything is uncomfortable — settings can be adjusted.
How many sessions will I need?+
That is determined by your physician after evaluating you, and it varies from person to person. Be aware that the research literature has not settled on a standard protocol; recent reviews note continuing disagreement about session counts, energy levels, and spacing. Any clinic quoting a universal number is quoting a business practice, not a clinical standard.
How long do the results last?+
This is genuinely not well established. Most randomized trials followed men for only about three months, so durability beyond a few months has not been well studied. We would be making it up if we gave you a figure in years, and we are not going to do that.
Is it covered by insurance?+
Generally no, because the treatment is not FDA-approved for erectile dysfunction. It is typically a direct-pay service. Our staff will give you clear pricing before you start so there are no surprises.
Can I use this along with pills like sildenafil or tadalafil?+
Possibly. The European Association of Urology's 2025 guidance mentions acoustic wave therapy as an option alone or in combination with a PDE5 inhibitor for men with mild to moderate erectile dysfunction. Whether that combination is right for you, and any decisions about medication, are up to your physician after reviewing your health history and current medications.
Is GAINSWave different from other acoustic wave therapy?+
GAINSWave is a brand name and a set of provider protocols built around low-intensity acoustic wave therapy; the underlying treatment is the same general modality offered under other names. Marketing sometimes frames the brand as a distinct or superior therapy. We would rather you focus on the evaluation, the physician performing the treatment, and an honest read of the evidence than on the brand.
Costs and appointment planning
Review pricing questions, insurance and coverage information, and telehealth visit planning before booking. Confirm the costs and services that apply to your individual care.
Ready to Get Started?
Call us at (404) 264-9553 or book a telehealth consultation. New patients qualify for our 1st month Semaglutide special — $399 (regularly $450).