Important Investigational-Treatment Disclosure

The American Urological Association considers low-intensity extracorporeal shockwave therapy for erectile dysfunction to be investigational.

This means the available evidence is not considered sufficient to establish it as routine, standard treatment for ED. Published studies have reported varying results and have used different:

• Device technologies
• Energy settings
• Treatment protocols
• Numbers of sessions
• Patient-selection criteria
• Outcome measurements
• Follow-up periods

These differences make it difficult to determine which patients, if any, are most likely to benefit or how long a possible response may last.

Patients should understand the investigational status, evidence limitations, treatment costs, alternatives and possibility of no improvement before choosing treatment.

Review the AUA Erectile Dysfunction Guideline

The Clinic Uses Radial Pressure-Wave Technology

EM Healthcare & Associates currently provides radial acoustic pressure-wave treatment.

Radial pressure-wave devices generate acoustic pulses that spread outward from the applicator into a relatively broad and superficial treatment area.

This is different from focused low-intensity extracorporeal shockwave therapy, which concentrates acoustic energy at a selected depth and focal point.

Much of the published ED research has evaluated focused or other low-intensity extracorporeal shockwave systems. Findings from those studies cannot automatically be assumed to apply to radial pressure-wave devices.

Focused shockwave therapy is not currently offered at EM Healthcare & Associates.

The terms “shockwave,” “acoustic wave” and “low-intensity shockwave” are sometimes used interchangeably in consumer advertising, but the technologies and treatment parameters are not necessarily equivalent.

What Is Erectile Dysfunction?

Erectile dysfunction is the consistent or recurrent difficulty achieving or maintaining an erection sufficient for satisfactory sexual activity.

Occasional difficulty can occur because of fatigue, alcohol use, stress, illness or temporary relationship factors. Persistent or recurring symptoms deserve medical evaluation.

ED may involve:

• Difficulty achieving an erection
• Difficulty maintaining an erection
• Erections that are not firm enough for sexual activity
• Reduced reliability of erections
• Changes in morning or spontaneous erections
• Reduced confidence related to sexual performance

ED is not simply an inevitable part of aging. It can occur at any adult age and may have more than one contributing cause.

Why an ED Evaluation Matters

An ED appointment should evaluate more than the sexual symptom.

Erectile function depends on coordinated cardiovascular, neurological, hormonal and psychological processes. A problem affecting any of these systems may contribute to ED.

The evaluation may review:

• When symptoms began
• Whether symptoms developed gradually or suddenly
• Erection firmness and duration
• Morning or spontaneous erections
• Sexual desire
• Ejaculation or orgasm concerns
• Medical and surgical history
• Cardiovascular risk factors
• Diabetes or blood-sugar concerns
• Blood pressure
• Medication and supplement use
• Tobacco, alcohol and substance use
• Sleep quality
• Stress, anxiety and mood
• Relationship or situational factors
• Previous ED treatments and results

A focused examination and laboratory testing may be recommended according to the patient’s history and risk factors.

ED and Cardiovascular Health

Erectile dysfunction can be associated with cardiovascular disease and may appear before more obvious cardiovascular symptoms.

An evaluation may identify or review risk factors such as:

• High blood pressure
• Diabetes
• Elevated cholesterol
• Tobacco use
• Obesity
• Reduced physical activity
• Sleep apnea
• Family history of cardiovascular disease
• Previous heart or vascular disease

Patients with chest pain, shortness of breath, limited exercise tolerance or known cardiovascular disease may require additional assessment before sexual activity or ED treatment.

Shockwave treatment should not be used to bypass appropriate cardiovascular evaluation.

Hormonal and Metabolic Factors

Low testosterone, diabetes, thyroid conditions and other metabolic concerns may contribute to sexual symptoms in selected patients.

Testing may include an early-morning total testosterone level and other laboratory studies when clinically appropriate.

A low testosterone result should be interpreted in context and may require repeat testing or additional evaluation. Testosterone treatment is not appropriate for every man with ED and should not be started based on symptoms alone.

Medication-Related Erectile Dysfunction

Prescription medicines, nonprescription products and substance use can affect erectile function.

Potential contributors may include certain:

• Blood-pressure medications
• Antidepressants
• Anti-anxiety medications
• Hormonal treatments
• Prostate medications
• Opioids
• Sedatives
• Alcohol or recreational substances

Do not stop a prescribed medication without discussing it with the prescribing clinician. The goal is to identify possible contributors and consider safe alternatives when appropriate.

Psychological and Relationship Factors

Stress, anxiety, depression, trauma, relationship concerns and performance anxiety may contribute to ED or make a physical condition more difficult to manage.

Psychological contributors do not mean the symptoms are imaginary. Physical and psychological factors frequently overlap.

Counseling, sex therapy or mental-health support may be recommended when these factors appear relevant.

Who May Be Considered for Radial Acoustic-Wave Treatment?

Radial acoustic-wave treatment may be discussed with adult men who:

• Have been medically evaluated for ED
• Understand that treatment is investigational
• Have realistic expectations
• Understand that improvement is not guaranteed
• Are willing to consider established alternatives
• Do not have a contraindication or unresolved medical concern
• Accept the self-pay cost of treatment

Being eligible for a consultation does not mean treatment will be recommended.

Patients with severe, complex or rapidly changing symptoms may need evaluation by a urologist, cardiologist, endocrinologist or another appropriate specialist.

What Happens During Treatment?

Treatment is performed in a private clinical setting.

The provider identifies the external treatment areas and applies coupling gel to help transmit the acoustic pulses. A handheld applicator is then placed against the skin and moved according to the treatment protocol.

Patients may feel tapping, pulsing, pressure or mild sensitivity. Treatment should remain tolerable. Tell the provider about pain, numbness, dizziness or another unexpected symptom.

Treatment is non-surgical and does not involve an incision. Anesthesia is not routinely required.

How Long Does Treatment Take?

The active pressure-wave portion of an appointment may take approximately 15 to 30 minutes, depending on the protocol.

The initial appointment may take longer because it can include:

• Medical and sexual history
• Medication review
• Cardiovascular risk review
• Focused examination
• Discussion of laboratory testing
• Explanation of investigational status
• Review of alternatives
• Informed consent
• Treatment planning

How Many Sessions Are Needed?

There is no universally accepted radial acoustic-wave protocol for erectile dysfunction.

Published shockwave studies have used different treatment schedules, and protocols involving focused devices cannot automatically be applied to radial technology.

If treatment is offered, the provider will explain:

• The proposed number of sessions
• Treatment frequency
• Cost per session or package
• When progress will be reassessed
• When treatment should be discontinued
• What would count as a meaningful response

Patients should not be encouraged to continue an ineffective treatment simply to complete a prepaid series.

What Results Should I Expect?

No specific result can be promised.

Some patients may report changes in erection firmness, reliability or response to other ED treatments. Others may experience little or no meaningful improvement.

Radial acoustic-wave treatment does not guarantee:

• Firmer erections
• Spontaneous erections
• Improved sexual performance
• Increased penis size
• Increased testosterone
• Increased sexual desire
• Elimination of ED medication
• Permanent results
• Prevention of future ED
• Treatment of cardiovascular disease
• Improvement after a specific number of sessions

A temporary change should not automatically be interpreted as permanent improvement.

Evidence Limitations

Research involving low-intensity shockwave therapy for ED remains difficult to interpret because studies differ in technology, energy delivery, treatment schedule, patient population and outcome measurement.

Additional limitations include:

• Small study populations
• Short or inconsistent follow-up
• Different definitions of treatment success
• Variable use of placebo or sham treatment
• Differences in baseline ED severity
• Differences in cardiovascular and metabolic health
• Limited evidence for radial devices
• Limited information about long-term durability
• Inconsistent reporting of adverse effects

For these reasons, treatment should be presented as investigational rather than established or proven.

Established and Alternative ED Treatments

Patients should be informed about established alternatives before choosing investigational treatment.

Depending on the patient, options may include:

• Lifestyle and cardiovascular-risk management
• Review of contributing medications
• Oral prescription medications
• Vacuum erection devices
• Intraurethral medication
• Penile injection therapy
• Counseling or sex therapy
• Hormonal treatment when a confirmed deficiency is present
• Urology referral
• Penile prosthesis surgery for appropriately selected patients

Each option has different benefits, risks, costs and contraindications.

Oral ED medications are not safe for every patient, particularly when certain nitrate medications are used. Medication decisions should be made with a qualified healthcare professional.

Contraindications and Precautions

Treatment may need to be avoided, postponed or modified when certain risks are present.

Tell the provider if you have:

• Active infection, rash, ulcer or open wound in the treatment area
• Known or suspected cancer in the treatment area
• Blood clot or suspected thrombosis
• Bleeding disorder
• Anticoagulant or blood-thinning medication use
• Significant loss of sensation
• Recent pelvic or genital surgery
• Recent injury
• Penile implant or other implanted device
• Severe vascular disease
• Uncontrolled cardiovascular disease
• Unexplained penile pain
• Penile curvature or a palpable penile plaque
• Active genital symptoms that have not been evaluated

This list is not exhaustive. Candidacy must be determined individually and according to the device instructions.

When to Seek Prompt Medical Care

Shockwave treatment is not emergency care.

Seek prompt medical attention for:

• Chest pain or shortness of breath during sexual activity
• A painful erection lasting four hours or longer
• Sudden severe penile or testicular pain
• Penile trauma
• Significant swelling or discoloration
• New neurological symptoms
• Signs of infection
• Symptoms of a blood clot
• Sudden ED accompanied by other concerning symptoms

Call 911 for a medical emergency.

Insurance and Self-Pay

Radial acoustic-wave treatment for erectile dysfunction is generally offered as a self-pay service.

Because the treatment is investigational, health insurance plans commonly do not cover it. Patients should receive clear information about:

• Evaluation fees
• Per-session pricing
• Package pricing
• Payment requirements
• Cancellation or refund policies
• Reassessment points
• Whether any related medical services may be billed separately

A medically necessary evaluation or laboratory testing may have different insurance eligibility than the acoustic-wave treatment itself.

Patients are responsible for confirming benefits with their insurance carrier and determining whether an HSA or FSA may be used.

Informed Decision-Making

Before beginning treatment, patients should understand:

• The AUA considers ED shockwave therapy investigational
• The clinic uses radial pressure-wave technology
• Radial and focused shockwave devices are not equivalent
• Much of the research has involved focused or other shockwave systems
• Evidence for radial treatment is limited
• Improvement is not guaranteed
• Long-term durability is uncertain
• Established treatment alternatives are available
• Additional evaluation or referral may be recommended
• Treatment is generally self-pay

Patients should have an opportunity to ask questions before consenting to care.

Schedule a Confidential ED Evaluation

The first step is identifying possible causes of erectile dysfunction and reviewing appropriate treatment options.

Frequently Asked Questions