Everything you need to know about Penile Shockwave Therapy for Erectile Dysfunction.

The Future of ED Therapy & A Potential Cure

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Erectile Dysfunction (ED) Definition

Erectile dysfunction (ED) is defined as a persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance that often lasts for more than 6 months (NIH Consensus Conference, 1993). This is the definition for ED according to the NIH. It’s important to note that even if a man can achieve an erection in private, but can still not use it for satisfactory sexual activity that is defined as ED. Many men may be able to get an erection without a partner present, but if a man cannot use the erection for sexual activity he is defined as having ED. Also, note the word “persistent” in the medical definition of ED by the NIH. A man must not be able achieve an erection rigid enough for sexual activity on several accounts (defined as long as 6 months by the NIH), not just one time, in order to have the definition of ED. The American Urologic Association (AUA) definition of ED does not define a time period (ie. 6 months in NIH ED definition) to be defined as having ED. The AUA definition of ED states:

ED is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.

This is the most common definition of ED used today by urologists and medical practitioners. The ability to treat a patient for ED revolves around a man’s inability to have enjoyable and satisfactory (per his account) sexual activity. The principles of ED treatment are:

1) Restoring sexual enjoyment

2) Enhancing sexual function

3) Optimizing Quality of Life for both a man and his partner

4) Improving personal relationships

What are the causes of ED?

Erectile Dysfunction is one of the most common conditions in men above 40 years age. Approximately 100 million men worldwide have erectile dysfunction. The most common causes of erectile dysfunction are:

1) Hypertension

2) Cardiovascular Disease

3) Dyslipidemia

4) Diabetes Mellitus

5) Lifestyle Factors (lack of exercise, poor nutrition etc.)

6) Alcohol Use

7) Obesity

8) Physical inactivity

9) Smoking

10) Low-Testosterone levels

What are the Different Types of ED?

While there are a variety of conditions that cause ED, each condition effects the body differently (pathophysiology). As a urologist it is important not only to define the cause of ED but also identify the underlying pathophysiology. There are several underlying mechanisms that cause ED. They are:

· Psychogenic ED

· Neurogenic ED

· Vasculogenic ED

· Iatrogenic ED

· Endocrine Causes

a. Low-T

b. Elevated Estrogen Levels

c. Elevated SHBG

Psychogenic ED

Psychogenic ED is a non-organic mechanism that makes it difficult to achieve an erection. Psychogenic ED is a type of performance anxiety, an adrenaline mediated response. A man can get overly nervous, anxious or frightened during sex and not perform well during sexual activity. The surge of noradrenaline (a sympathetic hormone) activates the “fight or flight” response and arousal can be lost. Think of it as trying to have an erection while running from a bear, it just will not happen because you are freighted and nervous. Medical conditions such as anxiety, depression, and stress accompany psychogenic ED. Treatment revolves around reducing performance anxiety.

Neurogenic ED

Neurogenic erectile dysfunction is caused by a condition that effects nerve signaling to the corpora cavernosa. This can be secondary to spinal trauma, diabetes, lumbar disc disease, brain injury, radical pelvic surgery (radical prostatectomy). Typically, sacral lesions or neurologic insults in this area of the spinal cord result in ED. Nerve injury or reduced nerve function results in reduced Nitric Oxide (NO) release available to the smooth muscle of the penis. Lack of (NO) causes reduction and loss of smooth muscle cells in the penis and increased fibrosis in the penis causing venous leak resulting in ED. Treatments revolve around penile rehab and daily PDE5 inhibitors to improve penile blood flow. Patient’s with neurogenic ED can be ultra-sensitive to oral ED meds such as Viagra or Cialis or penile injections (ie. Trimix, Bimix, Alprostadil). Lowering the dose of medication usage in this subset of patients may be necessary.

Vasculogenic ED

An erection is a vascular phenomenon. In order for a man to achieve an erection, blood vessels and penile corpora cavernosa muscle must dilate to accommodate increase blood flow. Vasculogenic erectile dysfunction is a direct result of arterial insufficiency and/or arterial stenosis. Medical conditions such as obesity, hypertension, high cholesterol, diabetes can cause atherosclerosis, narrowing blood vessels and causing decreased blood vessel wall elasticity. In combination, these vascular changes reduce the ability of the penis to fill with blood during arousal lending to decreased rigidity, length and ultimately ED.

Endocrine Causes

It is well known that androgens, primarily testosterone, play a major role in penile development, physiology and health. Men with low testosterone levels can have erectile dysfunction. Androgen receptors in the corpora cavernosa (penile tissue) play an integral role in the erectile pathway. Androgens also are key to arousal and sexual desire which are integral to the erectile response to erotic stimuli. Several clinic studies have shown that castration in animals reduces androgen and testosterone levels, decreasing intracavernosal pressures. This low-pressure profile within the penile tissue is a direct result of reduced arterial inflow and altered veno-occlusion necessary for an erection to occur.

What is penile shockwave for ED?

Penile shockwave therapy for erectile dysfunction, also called low intensity shockwave therapy (LISWT) is a nonpainful, noninvasive therapy that can enhance erectile response, rigidity, sensation, break up penile plaques and improve response to oral ED meds.

A shockwave is defined as an abrupt change in pressure produced by an object that travels faster than the speed of sound. The use of shockwave therapy in the field of medicine was first noticed during the second world war. The first identification of the effects of shockwaves on human tissue was when underwater bombs exploded causing nearby castaway lung tissues to be damaged despite no external signs of damage on the skin. In 1971 in Germany, shockwave forces were applied to breaking up kidney’s stones and gallbladder stones. Since the 1980’s shockwave therapy has been primarily utilized in the field of urology and cardiology to treat kidney stones and revitalize ischemic cardiac tissue respectively. It has not been until recently that the effects of shockwave therapy on penile tissues, at a significantly lower power, frequency and pulse rate, have been discovered to enhance blood flow and vasculogenisis to enhance erectile dysfunction.

Penile shockwave therapy today utilizes a small handheld device that delivers small pulsatile shockwaves and pressure forces to the penile tissue. The therapy is not painful, requires no downtime, no adverse events and results can be experienced in less than weeks in according to some studies.

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How does Penile shockwave therapy work?

There are several different theories how penile shockwave therapy enhances penile erectile function. While all theories may differ in mechanism, they all point towards improving penile blood, improving vascular growth and renewal, improving nerve function and breaking down fibrotic tissue within the penis to enhance erectile function.

The most prominent hypotheses behind shockwave therapy for the treatment of ED stems in part from the therapeutic uses of shockwave waves to induce angiogenesis (new blood vessel growth). When an ultrasound wave is in contact with specific cells, the mechanical vibration of the shockwave wave on the cells, can induce cell proliferation. Initial use of LISWT in other medical fields, saw the advantages of new blood vessel growth and tissue renewal when shockwave therapy was used to heal diabetic feet and damaged/ischemic cardiac tissues (heart cells). This theory is central to the improvement in vascular flow and erectile function after shockwave therapy has been applied. Several studies have observed increased smooth muscle cells and new vascular growth in corpora cavernosum tissue after shockwave therapy.

A hypothesis by other clinical studies, focuses on improving neurogenic components of ED. Shockwave therapy has the potential to activate dormant Schwann cells (nerve cells) within the dorsal nerve of the penis, activation of endothelial cells and improve nitric oxide release to enhance vasodilation during erotic stimuli.

For the treatment of Peyronies disease, a condition in which a fibrotic scar develops within the penis, causing ED, penile curvature, and pain with erection penile shockwave therapy has been utilized as nonstandard and investigational option. In this instance, shockwave therapy when applied to penile plaque may soften the plaque to assist in straightening the phallus and may cause an inflammatory reaction that can breakdown the plaque.

Penile shockwave therapy has been studied extensively since 2010. Penile shockwave therapy for ED has been a European Urologic Association potential first line treatment for ED since 2013. LISWT is the only therapy available today that improves erectile function by potential treating the underlying physiology and may provide a cure for ED.

Does penile shockwave therapy really work?

Several clinical trials and studies have shown that penile shockwave therapy can work to improve erectile function. 60% men appear to achieve successful results from therapy as measured by IIEF scores with improved erectile response lasting up to and beyond 12 months. To date, there have been 11 randomized controlled studies investigating the effects of penile shockwave therapy on erectile function. Results are promising and under the right patient conditions, penile shockwave therapy can assist and improve erectile functional, blood flow, reduce penile pain and increase penile sensation.

Penile Shockwave Therapy in men with ED non-responsive to oral ED Meds

There have been several studies that investigated that use of penile shockwave therapy to improve a man’s response to ED meds such as Viagra or Cialis. Studies are encouraging and suggest that shockwave therapy could play a new role in the ED algorithm to enhance response to standard guideline therapies. Some studies have reported a 40% improvement in erectile functional in men utilizing Li-ESWT while on oral ED medication.

What is GainsWave ® ?

Gainswave ® as reported by the Urology Times is a “marketing organization that educates consumers and raises public awareness of low intensity shock wave therapy for erectile dysfunction”.

Can penile shockwave therapy increase my penis length and size?

Penile shockwave therapy at this time has not documented any increase in penile length. Some men who undergo penile shockwave therapy may report an increase penile size. This may be too due to an increase in blood flow with an erect phallus and not a true increase in size. Currently the treatment for improving penile length is penile extenders or incising the penile suspensory ligament. The penile suspensory ligament maintains an erection pointing up. Cutting this ligament does allow the penis to protrude more from the body but can also cause injury and possible penile anesthesia (numbness). Penile injectables and fillers have been used to increase penile girth but have complication rates and are not advised.

Is penile shockwave therapy safe?

According to several well published studies and clinicians there have been no reported negative impacts of penile shockwave therapy for the treatment of erectile dysfunction. Therapy is safe and can be effective in the right population of men who suffer from ED.

How long does each therapy cycle?

Each cycle of penile shockwave therapy is approximately 20-30 minutes in duration. After a numbing cream is applied to the phallus and allowed to sit for approximately 5 minutes, therapy is started.

There is not standardized protocol for penile shockwave therapy. Providers currently use study protocols often consisting of 1-2 sessions per week.1500- 5000 shockwaves are applied to the corpora cavernosa and crus of the penis. Therapy can be delivered in a variety of ways depending on the shockwave machine utilized from a handheld device or fixed emitter.

Who is a good candidate for penile shockwave therapy?

At this time there are no guideline statements to identify the ideal patient for penile shockwave therapy. The American Urologic Association (AUA) in 2018 advised that therapy is still investigational. All patients who undergo penile shockwave therapy should know that this modality of therapy is not FDA approved and results, treatment protocols and side effects are not fully understood. However, penile shockwave results have been astounding and a novel therapy option for men with ED. Currently penile shockwave therapy is being and is best utilized for men in the following clinical situations:

1) Men with mild to moderate neurogenic or vasculogenic ED

2) Men who do not desire to be on Viagra or Cialis

3) Men who fail to achieve an erection on Viagra or Cialis

4) Men who desire to improve their erectile response, erectile size and rigidity while use oral ED meds

5) Men who have failed to respond to ED meds and do not desire penile injection therapy or MUSE ®.

Penile shockwave therapy for Peyronies disease?

Peyronies disease is a condition in which a penile plaque (fibrotic scar) develops within the penis and causes restriction of blood to the penis the impedes erectile function, may often cause pain and curvature of erection preventing intercourse. Shockwave therapy for Peyronies disease is still investigation but several well documented and published studies have seen excellent results with therapy to improve penile pain.

Is penile shockwave therapy for erectile dysfunction FDA approved?

Currently no penile shockwave therapy device is FDA approved. All patients who undergo low intensity penile shockwave therapy should be advised that therapy is investigational.

How does long does shockwave therapy results last?

The verdict is still pending, but consensus by many studies and patients is up to one year. Results are also dependent on the underlying cause of ED and patient health and comorbidities. Patients with mild to moderate ED and less medical conditions tend to have better and lasting results.

What are the side effects of penile shockwave therapy for ED?

According to statements made by the European Society of Sexual Medicine low intensity shockwave therapy for the treatment of erectile dysfunction is very well tolerated and is without clinically significant adverse side effects.

When can I have sex after penile shockwave therapy for ED?

Men can return to having normal sexual activity as soon as possible and during treatment.

How much does shockwave therapy cost for ED?

Penile Shockwave Therapy for ED can cost as much as 1000$-3000$ on average depending on the clinic and device used. While may clinics do offer this novel ED therapy, its use is still investigational.

How long does penile shockwave therapy for ED take to perform?

Therapy can take approximately 15-30 min. Patients often undergo 1-2 treatments per week for approx. 6-8 weeks. Although no therapy shockwave therapy protocol has been published or standardized this often a general rule.

Will shockwave therapy improve my erectile response to ED meds?

Approximately 40-50% of men do not respond to oral ED medications depending on the etiology of erectile dysfunction. Penile low intensity shockwave therapy (LISWT) can and has been utilized to enhance the response to oral ED meds in clinical studies (phosphodiesterase inhibitors- PDE5i).

Can I have penile shockwave therapy for ED while on a blood thinner (anticoagulant)?

Penile shockwave therapy is well tolerated and considered safe for patients on anti-coagulants. A study published in the journal of sexual medicine reviewed the treatment side effects of men undergoing low intensity shockwave therapy for vasculogenic ED. These men were also on anticoagulant therapy during the ED treatment. There were no reported adverse events and no patients reported any bleeding or bruising secondary to shockwave therapy while on antiplatelet medication.

For more information about penile shockwave therapy and to find a trusted clinic that offers this novel ED therapy, speak with a REGENX Health provider today. Click Here.