The introduction of PDE-5 inhibitors like Viagra revolutionized the treatment of ED (erectile dysfunction).
It brought about significant changes by offering a non-invasive alternative to invasive treatments such as penile surgery and injections.
The availability of oral medication made treatment simpler, more accessible, and convenient.
It also transformed the general public's attitude towards addressing related issues.
People became more accustomed to and willing to discuss problems that were previously difficult to talk about with healthcare providers.
However, are there any other updated and more groundbreaking treatment options available after these advancements?
The answer is yes.
A brand-new, breakthrough, and unprecedented, treatment method— regeneration therapy, also known as restorative therapies, focuses on promoting tissue repair and regeneration.
Regenerative therapies are technologies based on the concept of "repairing” or "replacing” diseased tissue by "stimulating" or "introducing" regenerative agents.
Currently, there are three major categories being used or studied in the field of erectile dysfunction treatment:
i. Low-Intensity Shockwave Therapy (LiSWT)
ii. Platelet-Rich Plasma (PRP)
iii.
Among them, extracorporeal shockwave therapy (LiSWT) is the earliest treatment with the most research evidence and the earliest approval.
Therefore, let's provide a brief yet comprehensive introduction to low-intensity shockwave therapy.
1.Mechanism
Shockwaves cause direct microscopic mechanical stress, leading to the recruitment of progenitor and resident stem cells.
Shockwaves can induce the release of vascular endothelial growth factor (VEGF) and nitric oxide, improving microcirculation and driving neo-angiogenesis.
It also causes a local increase in nitric oxide and promotes nerve regeneration, as well as the regeneration of cavernosal smooth muscle and endothelium.
2.Efficacy
At present, a large number of studies have confirmed the curative effect of shockwaves on erectile dysfunction.
Although these studies differed from each other in many conditions (ex: patient's severity of erectile dysfunction; shockwave equipment, energy, treatment location; assessment method; follow-up duration), making it challenging to conduct comprehensive comparisons, some conclusions can still be drawn.
a.Despite the variations in conditions, both individual studies and large-scale meta-analyses
have affirmed that low-intensity shockwave therapy (LI-SWT) can significantly increase the International Index of Erectile Function (IIEF) scores and Erectile Hardness Scores (EHS) in vasculogenic ED patients.
Regardless of the differences in the conditions of patients in different studies, in general terms, the proportion of patients who perceive satisfactory improvement is about 40-80%.
b. LI-SWT can improve erectile quality even in patients with severe sexual dysfunction who are non-responders or inadequate responders to medication (PDE-5 inhibitors) , thereby reducing the immediate need for more invasive treatments.
c. Sustained effectiveness:
Based on several large literature reviews to date, most studies with follow-up periods within one year have found that the maximum therapeutic effect following completion of treatment can be maintained for at least 3 months, and may gradually diminish thereafter.
However, the positive effects of LI-SWT can last up to 12 months after treatment.
In the current study with the longest follow-up period of five years, 30 patients with an average age of 55.8 years, predominantly with moderate erectile dysfunction lasting over 18 months, and most of whom had concomitant cardiovascular diseases, underwent 12 sessions of LI-SWT (twice weekly for six weeks).
IIEF-5 questionnaire scores, changes in Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, and overall satisfaction (on a 5-point scale) were continuously tracked at 12, 24, 48, and 60 months.
It was observed that even at the fifth year,
40% of patients showed an improvement in IIEF-5 scores by ≥5 points,
48% of patients had EDITS scores >50%,
and 40% of patients maintained an overall satisfaction level of 4 out of 5.
No adverse reactions or side effects were reported during the five-year follow-up period.
In addition, the study found that the fastest decline in treatment efficacy and satisfaction occurred between the first and second year after treatment, but then it would remain at a certain level thereafter. (PS)
d. Patient Factors and Their Impact on Treatment:
Patients with mild to moderate erectile dysfunction (ED), younger age, minimal cardiovascular comorbidities, and no diabetes or cavernous nerve injury are likely to experience better erectile function recovery and spontaneous erections when undergoing shockwave therapy.
However, there are also research findings suggesting that patients with moderate and/or severe ED may have better results in mean IIEF scores. (source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487775/).
e. Combining medication therapy for better treatment outcomes:
Several meta-analyses showed a statistically significant erectile function (EF) improvement in patients with mild and severe ED and that patients who used PDE5i during treatment showed better results than those who did not.
Combination treatment with LI-SWT and once daily tadalafil led to a 20% higher rate of patients achieving minimal clinically important difference (MCID) at three months after treatment compared to LI-SWT alone
f. Treatment efficacy by different shockwave machines:
There are three main types of machines based on different principles of generating shockwaves:
i. Electromagnetic sources of energy: Duolith SD1 (Storz Medical, Switzerland), Aries 2 (Dornier, Germany), and Renova (Direx, Germany).
ii. Electrohydraulic source of energy: Omnispec ED1000 (Medispec) and MTS Urogold 100 (MTS, Konstanz, Germany).
iii. Piezoelectric source of energy: PiezoWave (ELvation, Germany).
Currently, there are no studies directly comparing these machines to each other.
However, numerous studies have confirmed the effectiveness of different types of shockwaves, including various machine models.
Additionally, these machines have obtained approvals for their indications in multiple countries.
Therefore, individuals do not need to be overly concerned about the differences in machines.
As long as the machine has obtained approval for the indications from the Ministry of Health and Welfare, it is considered a good treatment option.
At last, how should we view the role and impact of extracorporeal shockwave therapy in the treatment of erectile dysfunction?
Here, I quote a commentary from the European Association of Urology guidelines to summarize:
It is the only currently marketed treatment that might offer a cure, which is the most desired outcome for most men suffering from ED.
References：
EAU Guidelines
https://uroweb.org/guidelines/sexual-and-reproductive-health
AUA update series, volume 41, Lesson 28
https://auau.auanet.org/US2022-28
Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study
https://pubmed.ncbi.nlm.nih.gov/22425129/
Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials
https://pubmed.ncbi.nlm.nih.gov/30664671/
Review of the Current Status of Low Intensity Extracorporeal Shockwave Therapy (Li-ESWT) in Erectile Dysfunction (ED), Peyronie's Disease (PD), and Sexual Rehabilitation After Radical Prostatectomy With Special Focus on Technical Aspects of the Different Marketed ESWT Devices Including Personal Experiences in 350 Patients
https://pubmed.ncbi.nlm.nih.gov/32499189/
https://www.sciencedirect.com/science/article/pii/S2050052120300317
Low-intensity shockwave therapy (LiST) for erectile dysfunction: a randomized clinical trial assessing the impact of energy flux density (EFD) and frequency of sessions
https://pubmed.ncbi.nlm.nih.gov/31474753/
Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study
https://pubmed.ncbi.nlm.nih.gov/34126432/
Clinical Practice Guideline Recommendation on the Use of Low Intensity Extracorporeal Shock Wave Therapy and Low Intensity Pulsed Ultrasound Shock Wave Therapy to Treat Erectile Dysfunction: The Asia-Pacific Society for Sexual Medicine Position Statement
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752510/
Efficacy and safety of low-intensity shockwave therapy plus tadalafil 5 mg once daily in men with type 2 diabetes mellitus and erectile dysfunction: a matched-pair comparison study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7406094/
Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis
https://pubmed.ncbi.nlm.nih.gov/27321373/
Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487775/)
Minimal Clinically Important Differences in the Erectile Function Domain of the International Index of Erectile Function Scale
https://www.sciencedirect.com/science/article/abs/pii/S0302283811007913
(PS: The proportions of patients with an improvement in IIEF-5 scores by ≥5 points were 60%, 45%, 40%, and 40% at 12, 24, 48, and 60 months, respectively.
EDITS scores >50% were recorded in 70%, 55%, 50%, and 48% of patients at the same respective time points.
The proportions of patients with an overall satisfaction level of ≥4 were 68%, 50%, 40%, and 40% at 12, 24, 48, and 60 months, respectively.)
