Shockwave Therapy vs Drug Therapy For Erectile Dysfunction
Erectile dysfunction (ED) is a prevalent and multifaceted condition affecting mainly males over 40 years old, with its global prevalence on the rise. It is characterised by the consistent or recurrent inability to achieve and maintain an erection sufficient for satisfactory sexual performance. The causes of ED are diverse, including organic, psychogenic, and mixed factors, often intertwined with comorbidities such as diabetes, cardiovascular disease, and neurological disorders. Understanding these root causes is crucial for guiding appropriate management.
ED’s psychological and emotional impact can be profound, affecting both the individuals and their partners. Left unaddressed, it can lead to anxiety, depression, reduced self-esteem, and strained relationships. Therefore, a comprehensive evaluation, management and treatment for ED are essential.
Erectile dysfunction (ED) is a common penile disorder that impacts around 30 million men in the United States. However, only about 6 million seek medical help, and even fewer undergo treatment. Specifically, out of the 4.2 million men who receive medication for ED, less than 2.2 million continue taking the drug despite approximately 3.8 million prescriptions being filled for it in the year 2000. Reasons for discontinuing pharmacologic therapy can vary and may include factors such as ineffectiveness, side effects, potential worsening of the underlying condition, psychological aspects, and issues related to partners.
There are a variety of ED medications that work in different ways to achieve an erection. However, like with any medication intervention, there are risks. These include:
Sildenafil/Tadalafil/Vardenafil
Sildenafil, commonly known as Viagra, is prescribed to address erectile dysfunction (impotence) in men. It is also used under the brand names Liqrev and Revatio to enhance exercise capacity in adults and children aged one year and older with pulmonary arterial hypertension, a condition characterised by high blood pressure in the vessels supplying blood to the lungs. Belonging to the class of medications called phosphodiesterase (PDE) inhibitors, sildenafil functions by augmenting blood flow to the penis during sexual stimulation, thereby facilitating an erection. Additionally, it alleviates pulmonary arterial hypertension symptoms by dilating the blood vessels in the lungs, easing blood circulation.
While ED medication such as sildenafil generally has high response rates, up to 20%–40% of patients may not respond adequately. According to a recent report, about 10%–27% of men may require dose adjustments to maintain effectiveness over time, and approximately 12% discontinue sildenafil within two years due to a perceived lack of efficacy. In clinical trials lasting up to 6 months and involving hundreds of men aged 19 to 87 with erectile dysfunction, sildenafil was assessed at doses in randomised, double-masked, placebo-controlled settings. Among the reported adverse effects occurring at a rate of over 2% were headache, flushing, dyspepsia (indigestion), nasal congestion, urinary tract infection, abnormal vision, diarrhoea, dizziness, and rash. Notably, no instances of priapism were documented. However, postmarketing surveillance has highlighted concerns, with at least 39 deaths linked to sildenafil use observed in men with heart disease, those taking nitrate medications, and individuals with poor physical health due to lack of exercise. Many affected individuals had multiple comorbidities and were on various medications.
Intracavernous Injections
Intracavernous Injections (ICI) involve the direct injection of potent medications into the penile cavities to induce an erection. The combination of two medicines called papaverine and phentolamine, are administered directly into the cavernous region of the penis. The treatment has emerged as a significant tool in diagnosing and treating erectile dysfunction. However, a notable drawback is the occurrence of prolonged erections, known as priapism, especially during initial diagnostic procedures. Additionally, localised hematomas have been reported in some patients post-administration.
In a study involving 672 men with erectile dysfunction who underwent intracorporeal papaverine hydrochloride injections, 18 individuals experienced priapism. Fortunately, swift intervention involving blood aspiration, irrigation, and alpha-agonist injections effectively resolved the condition. Interestingly, those prone to priapism tended to be younger, with an average age of 45 compared to 51 years for those unaffected. However, prolonged usage of this therapy may lead to intracavernous fibrosis and tolerance to its desired effects over time.
Topical Gels
Topical gels such as Eroxon or Alprostadil provide a user-friendly and non-invasive solution, diverging from the conventional routes of oral medications or injections. Applied directly onto the penis, these gels permeate the skin, facilitating the delivery of active components to the erectile tissue, thereby enhancing blood flow. Typically infused with vasodilators or similar agents, they aid in vasodilation, relaxing blood vessels, improving circulation, and promoting enhanced erectile function. While effectiveness can differ from person to person, these gels offer a discreet and straightforward approach to addressing erectile dysfunction.
Several trials have demonstrated the safety and efficacy of alprostadil cream as a treatment for Erectile Dysfunction (ED). Notably, a double-masked, placebo-controlled study investigated using 1% alprostadil topical gel. Overall, a higher incidence of minimal erythema or a pink, uniform discolouration at the application site was observed in the alprostadil group compared to the placebo. However, In an integrated analysis involving 1,732 ED patients, the safety profile of topical alprostadil cream was further examined. Most adverse events (AEs) were mild to moderate, with no treatment-related severe AEs reported. The most common AEs were localised to the application site, including penile burning, genital pain, and erythema, which typically resolved within 2 hours. Notably, 46 patients (2.7%) withdrew from the study due to AEs. Around 5.6% of all AEs were partner-related, mainly mild vaginal burning, all resolving within 2 hours, with only five partners (0.4%) withdrawing from the study due to AEs.
Testosterone Replacement Therapy
The National Institute of Health (NIH) defines ED as the “inability to achieve or maintain an erection that is satisfactory for sexual performance”. Achieving an erection involves a complex interplay of vascular, neurological, psychological, and hormonal elements. It begins with the release of nitric oxide and other neuroendocrine factors, which prompt the relaxation of smooth muscles within the cavernous arteries and tissues, leading to heightened blood flow into the penis. As the corpus cavernosum becomes filled with oxygenated blood, the veins responsible for draining it are compressed, sustaining the firmness of the erection. Testosterone plays a crucial role in mediating this initial release of nitric oxide.
Cross-sectional studies have revealed that men with low testosterone levels, as defined by the US Food and Drug Administration (levels below 300 ng/dL), exhibit a higher prevalence of Erectile Dysfunction (ED) compared to those with normal testosterone levels. Research also indicates that men undergoing androgen deprivation therapy (ADT) for prostate cancer experience a significant decline in erectile function alongside a reduction in testosterone levels. Moreover, several randomised controlled trials have underscored that administering testosterone to men with low testosterone levels leads to an improvement in erectile function.
The benefits of testosterone replacement therapy go well beyond erectile dysfunction. Restoring testosterone levels to normal levels through testosterone replacement therapy can effectively alleviate many of the symptoms associated with hypogonadism (reduction or absence of hormone secretion of the gonads). This includes improving mood, increasing energy levels, enhancing overall well-being, boosting sexual function, preserving lean body mass and muscle strength, promoting erythropoiesis, and maintaining bone mineral density (BMD). Additionally, there are positive effects on cognition and some cardiovascular risk factors. However, the risks associated with testosterone replacement therapy vary depending on factors such as age, lifestyle, and existing medical conditions. Potential risks include an increased risk of prostate cancer, worsening of symptoms related to benign prostatic hypertrophy, liver toxicity, tumour development, worsening of sleep apnea, congestive heart failure symptoms, gynecomastia, infertility, and skin disorders. It’s important to note that testosterone replacement therapy is not suitable for men seeking to father a child, as exogenous testosterone can suppress the hypothalamic-pituitary-testicular (HPT) axis, impacting fertility.
Extracorporeal Shockwave Therapy (ESWT) made its clinical debut in 1980 as a non-invasive lithotripsy treatment. Over the past two decades, it has evolved to address musculoskeletal disorders and promote bone growth. Shock waves generated by ESWT are now utilised to treat various orthopaedic conditions, including plantar fasciitis, shoulder tendinopathy, elbow tendinopathy, patellar tendinopathy, and achilles tendinopathy. Additionally, shockwave therapy has expanded its application to treat femoral head necrosis, patellar knee jaw, osteochondritis, and calcific shoulder tendonitis.
These high-energy sound waves, generated through a high-voltage explosion and underwater evaporation, induce neovascularisation (the growth of new blood vessels) at the tendon-bone junction and stimulate the release of growth factors like eNOS, VEGF, and PCNA. This process enhances blood supply, promotes cell proliferation, and facilitates tissue regeneration for tendon and bone repair.
What Exactly is a Shock Wave?
A shock wave is a powerful pressure wave observed in various elastic mediums like air, water, or solids. It’s generated by events like supersonic aircraft, explosions, or lightning strikes, leading to abrupt changes in pressure. Unlike sound waves, shock waves exhibit sudden and violent stress, density, and temperature alterations along their wavefronts. This unique characteristic causes shock waves to propagate differently from ordinary acoustic waves. Notably, shock waves travel faster than sound, increasing their speed as the amplitude rises. However, their intensity diminishes more rapidly than sound waves, as some energy converts into heat within the medium they traverse.
What Are The Different Forms of Shockwave Therapy?
There are two main types of ESWT: focused and radial shockwave therapy. Focused ESWT is widely utilised in clinical settings, involving high-energy pressure pulses that converge at a focal point, generating maximal pressure. These pulses consist of an initial high positive pressure wave, reaching up to 80 MPa, with a rapid rise time of 30-120 nanoseconds, followed by a negative wave of 5-10 MPa. With a short pulse duration of 5 microseconds, wave energy is discharged at tissue interfaces with varying acoustic impedances, inducing compressive and shear loads. This process leads to the formation and collapse of microscopic gas bubbles in interstitial fluid, known as cavitation, resulting in high localised stresses and mechanical stimulation. Conversely, radial ESWT features a diverging pressure field, with maximal pressure at the source. Some researchers argue that radial ESWT lacks the physical characteristics of accurate extracorporeal shockwaves and suggest referring to it as radial pressure wave therapy, highlighting its distinct nature.
Is Shockwave Therapy Painful?
Shockwave therapy offers a non-invasive approach to treatment, typically causing minimal discomfort during the procedure. Patients often describe the sensation as small pulses against the skin. Your practitioner can adjust the intensity of the shockwave device if you experience significant pain. Each session lasts only a few minutes; most patients find the discomfort manageable. Wearing loose clothing to your appointment can enhance comfort, especially if you need to lie on your front during the treatment. Moving freely in loose clothing facilitates the procedure and ensures a more comfortable experience.
How Long Is The Healing Process From Shockwave Therapy
After having shockwave therapy, the healing process typically unfolds gradually over time. Initially, patients may experience some soreness or discomfort in the treated area, a normal response to the therapy. This discomfort usually subsides within a few days as the body responds to the treatment. Over the following weeks, the shockwave therapy stimulates the body’s natural healing processes. It promotes the formation of new blood vessels (neovascularisation). It enhances the production of growth factors, which help repair damaged tissues. As a result, patients may notice a gradual reduction in pain and improved function. It’s important to note that the healing process varies from person to person, depending on factors such as the severity of the condition, overall health, and adherence to any post-treatment recommendations. In most cases, multiple sessions of shockwave therapy may be needed to achieve optimal results.
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