The Efficacy of Low-Intensity Shock Wave Therapy based on the Stratification of Erectile Dysfunction Patients: A Long-term Follow-up

doi:10.21203/rs.3.rs-4818057/v1

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The Efficacy of Low-Intensity Shock Wave Therapy based on the Stratification of Erectile Dysfunction Patients: A Long-term Follow-up

https://doi.org/10.21203/rs.3.rs-4818057/v1

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Background

Low intensity extracorporeal shockwave therapy (LIESWT) has a considerable positive influence on erectile function (EF) among individuals diagnosed with vasculogenic erectile dysfunction (ED). This research aimed to investigate the impact of LI-ESWT on several subcategories of ED and to determine the duration of the enhancement in erectile function by a comprehensive long-term follow-up.

Methods

This was a retrospectively collecting data from prospectively kept database. Individuals diagnosed with vasculogenic ED received 6–12 sessions of LI-ESWT with 5000 impulses at a dosage of 0.01 j/mm2. The therapy was administered employing the electromagnetic Dornier Aries® 1 machine. Each patient underwent at least 6 sessions of LI-ESWT. Subsequently, the participants had clinical assessment utilizing the International Index of Erectile Function (IIEF-EF) and the Erection Hardness Scores (EHS) domain score at three months after LI-ESWT, followed by assessments every 6 months. Additionally, the penile blood flow dynamics were assessed three months after LI-ESWT and during the final follow-up examination.

Results

A total of 42 individuals had been determined, with a mean age of 50 ± 12 years. The mean duration of ED was 31 ± 35 months, and the mean period of follow-up was 10 ± 6 months. The initial IIEF-EF score was 16 ± 6 and increased to 22 ± 6 after 3 months, and then decreased to 21 ± 6 at the final follow-up (p < 0.01). A minimal clinically significant variation was observed in 69% of participants at 3 months and in 60% of the entire study population at the final follow-up. The factors of risk that were shown to be related with a greater likelihood of MICD at 3 months had been age (p = 0.01), uncontrolled diabetes mellitus (DM) ratio (p = 0.04), hypertension (p = 0.24), cardiovascular disease (p = 0.8), smoking (p = 0.63), and ex smoking (p = 0.3).

Conclusions

Li-ESWT shows promising long-term effectiveness in treating various degrees of ED, as demonstrated by the enhancement in penile blood flow observed during the final follow-up. This effect is particularly notable in individuals with well-managed DM and older age.

Erectile Dysfunction

Low Intensity Extracorporeal Shockwave Therapy

Erection Hardness Scores

International Index of Erectile Function

In 2010, Vardi et al. pioneered the application of low intensity extracorporeal shockwave therapy (LIESWT) as therapy for erectile dysfunction (ED) ^[1]. LIESWT Therapies, is a novel therapeutic approach that specifically addresses the underlying pathophysiology of ED in order to improve erectile function. Unlike traditional methods, LIESWT doesn't require invasive procedures or the administration of pharmaceutical drugs ^[2].

Individuals suffering from vasculogenic ED (especially those who respond well to PDE5 inhibitors) may find LIESWT beneficial as a first-line non-pharmacological therapy. This therapy has been demonstrated to significantly improve erectile function, as evidenced by studies conducted by ^[3].

While the majority of the research investigations had follow-up periods of fewer than one year, a few have evaluated the efficacy of LI-ESWT in different organic (neurogenic, vasculogenic, and mixed) causes of ED.

The study subjects exhibited a diverse array of risk factors, such as their cardiovascular condition, diabetes, responses to PDE5I, and the length and severity of ED. Furthermore, there is considerable diversity in the parameters of therapy regimens and the techniques employed for implementing them.

The purpose of this work is to assess the efficiency of LI-ESWT in treating ED, specifically examining its impact on various subtypes of ED. Additionally, the work seeks to assess the long-term durability of the enhancement in erectile function following LI-ESWT treatment. Evaluation was conducted using clinical measures, such as the IIEF score, prior to and following the intervention, as well as radiological evaluation using penile duplex to demonstrate that neo-angiogenesis can significantly enhance penile vascular parameters. Furthermore, this research wants to assess the impact of various factors of risk, such as advanced age, obesity, DM, and cardiovascular conditions, on the effectiveness of LI-ESWT in managing ED. Ultimately, the goal is to develop a future nomogram that can anticipate which patients will be derived the greatest benefit from LI-ESWT.

This had been a retrospectively collecting data from prospectively kept database. During the period from December 2018 to January 2023, a total of 42 male subjects with ED were detected and participated in the study. The Faculty of Medicine at Cairo University gained approval from the ethical committee with the number (N-61-2023). The criteria for inclusion consisted of male subjects who had vasculogenic ED at different levels, regardless of whether they responded or did not respond to PDE-5 inhibitors. These patients were also required to be willing to participate in the scientific aspects of the work. The criteria for exclusion encompassed individuals who reported ED linked to specific conditions such as neurogenic ED, Peyronie's disease, prior penile and pelvic surgical procedures, congenital veno-occlusive dysfunction condition, prior pelvic irradiation, and/or concurrent administration of platelet-rich plasma injection.

Before being included, each participant underwent taking of sexual history, evaluations of erection hardness scores (EHS), and an assessment of erectile function utilizing the IIEF-EF domain. This was followed by an examination of hemodynamics of the penis and its vascularity performance utilizing colored penile duplex ^[4]. Participants with vasculogenic ED were categorized based on their IIEF - EF domain scores, which classified them as having mild, moderate, or severe ED ^[5]. The range for mild ED was from 17 to 25, for moderate ED it was from 11 to 16, and for severe ED it was from 6 to10.

Each participant received 6–12 sessions of targeted LI-ESWT utilizing the Dornier Aries® 1 machine, delivering 5000 impulses at an intensity of 0.01 j/mm2. The therapeutic program consisted of biweekly sessions for a duration of six weeks, then a two-week break, and then another round of biweekly sessions for three weeks. Every patient underwent a minimum of 6 sessions of LI-ESWT. The sites of LI-ESWT on the penis will encompass both the crura cavernosa and corpora cavernosa for every participant.

The primary objectives of this research were to assess the overall improvements in EF among those suffering from ED following LI-ESWT, assess the impact of LI-ESWT on various subtypes of ED based on severity, determine the duration of the enhancement in erectile function via long-term follow-up, and investigate the impact of various factors of risk such as advanced age, DM, cardiovascular conditions, and obesity on the effectiveness of LI-ESWT in managing ED.

The secondary objectives of the study included evaluating improvements of EF following LI-ESWT by assessing hemodynamics of penis utilizing the colored penile duplex. Additionally, the study recorded any adverse events that occurred during the LI-ESWT treatment to assess its safety.

Following the conclusion of the treatment protocol, all individuals underwent clinical assessment utilizing the EHS scale to evaluate their erectile function. Additionally, the IIEF-EF domain score was utilized to measure their EF at 3 months following LI-ESWT and subsequently every 6 months. Additionally, the penile blood flow dynamics were assessed 3 months after LI-ESWT and throughout the final follow-up examination.

Statistical analysis:

The data was summarized employing descriptive statistics. The data had been displayed using either the mean ± standard deviation (SD) or the median and interquartile range (IQR). The enhancement of erectile functions will be assessed by comparing the scores of the IIEF-EF Domain before and after the intervention, utilizing a predetermined minimally clinically important difference (MICD). The severity of ED will determine the extent to which the long-lasting impact of LI-ESWT will be assessed. The MICD was established at 2 points for mild ED, 5 points for moderate ED, and 7 points for severe ED. This information was derived from the literature source provided by (Rosen et al., 2011). The evaluations of both the Peak Systolic (PSV) and end diastolic velocities will be obtained in the before and post intervention colored penile duplex to assess the change in penile hemodynamics. The study examined how several risk variables affected the effectiveness of LI-ESWT. Multivariate stepwise linear and logistic regression models had been used to assess predictors before, during, and after the intervention. The tests conducted were two-sided, and statistical significance was determined by a p-value of ≤ 0.05. The statistical analyses have been performed employing MedCalc version 19.5.1 software for Windows, developed by MedCalc Software Ltd in Ostend, Belgium.

Out of the total of sixty individuals, 42 of them meet the eligibility criteria. The mean age of these individuals was 50 ± 12 years. Their mean duration of ED was 31 ± 35 months, and their mean follow-up period was 10 ± 6 months. Out of the total number of recipients, 43% had diabetes, and among them, 55% had their diabetes properly controlled. Thirty-eight % of the participants were current smokers, whereas 26% had stopped smoking. 35% of the individuals had hypertension, whereas 7% had cardiovascular conditions.

In terms of ED categorization, 40.5% of individuals had mild ED, 40.5% had moderate ED, and 19% had severe ED. The EHS has shown improvement, even considering the categorization prior to LI-ESWT. An individual with pre-intervention EHS of E1 has reached E4. Seven percent of those with E2 have progressed to E4 but none to E5. Of the subjects who were E3, 17% attained E4 and 7% reached E5 following the procedure. Twenty-one percent of those with E4 progressed to E5 following the shock wave treatment (Table 1). The hemodynamic alterations in the penis are discussed in Supplementary Table 1.

Table 1

Improvement of EHS in penile Duplex following LI-ESWT
	Post
Pre	E1	E2	E3	E4	E5
E1	0 (0.00)	0 (0.0%)	0 (0.0%)	1 (2.4%)	0 (0.0%)
E2	0 (0.00)	1 (2.4%)	1 (2.4%)	3 (7.1%)	0 (0.0%)
E3	0 (0.00)	0 (0.0%)	3 (7.1%)	7 (16.7%)	3 (7.1%)
E4	0 (0.00)	0 (0.0%)	0 (0.0%)	8 (19.0%)	9 (21.4%)
E5	0 (0.00)	0 (0.0%)	0 (0.0%)	0 (0.0%)	6 (14.3%)
p value	< 0.001
Data are described in number of cases (%). EHS: Erection Hardness Scores. LIESWT: Low intensity extracorporeal shockwave therapy.

The initial IIEF-EF score was 16 ± 6 and increased to 22 ± 6 after three months, and then decreased to 21 ± 6 at the final follow-up. In those who had mild ED, the initial IIEF-EF score was 22 ± 3. After three months, the score increased to 26 ± 4 and maintained stable at 25 ± 4 during the final follow-up. In individuals experiencing moderate ED, the initial IIEF-EF score was 15 ± 1. After three months, the score increased to 21 ± 4 and maintained stable at 20 ± 4 at the final follow-up. In those who had severe ED, the initial IIEF-EF score was 8 ± 2. After three months, the score increased to 15 ± 7 and maintained stable at 14 ± 7 during the final follow-up. All these effects were both clinically and statistically significant (p < 0.01), with the exception of the severe patients at the last follow-up (Table 2).

Table 2

IIEF EF score after LI-ESWT according to the sub-stratification od degree of ED
ED severity	IIEF pre	IIEF-3m	IIEF-last follow up
Overall	16.1 ± 5.7*	21.6 ± 6.1*	20.6 ± 6.1*
Mild	21.5 ± 3.4*	25.5 ± 3.7*	24.6 ± 4.3*
Moderate	14.7 ± 1.1*	20.9 ± 4.3*	19.7 ± 4.0*
Severe	7.6 ± 2.4*	15.1 ± 7.4*	14.1 ± 6.9
Data are described in mean ± SD. *: significant difference to other time points. LIESWT: Low intensity extracorporeal shockwave therapy. IIEF-EF: International Index of Erectile Function. ED: erectile dysfunction.

A minimal clinically significant change was seen in 69% of the participants at three months and in 60% of the whole group at the final follow-up. At three months, the MICD was attained for 77% of mild cases, and at the final follow-up, it was accomplished for 71%. The rate of achieving MICD for moderate patients was 65% at three months and 53% at the final follow-up. At the three-month mark, 63% of severe cases achieved MICD, while at the last follow-up, this percentage dropped to 50%. No significant difference existed in the sub-stratification at three months (p = 0.68) and at the last follow-up (p = 0.48) according to (Table 3).

Table 3

Improvement in erection with LIESWT according to the MICD
	Achieved MICD	Didn't achieve MICD	P-value
Three months follow up
Total	29 (69.0)	13 (31.0)	-
Mild	13 (76.5%)	4 (23.5%)	0.68
Moderate	11 (64.7%)	6 (35.3%)
Severe	5 (62.5%)	3 (37.5%)
Last follow up
Total	25 (59.5%)	17 (40.5%)	-
Mild	12 (70.6%)	5 (29.4%)	0.48
Moderate	9 (52.9%)	8 (47.1%)
Severe	4 (50.0%)	4 (50.0%)
Data are described in number of cases (%). LIESWT: Low intensity extracorporeal shockwave therapy. MICD: minimally important clinical difference.

The risk factors correlated with a greater risk of MICD at three months had been age (odds ratio (OR) 1.04, 95% Confidence Interval [CI] 1.01–1.07, p = 0.01), uncontrolled DM ratio (OR 0.13, 95% CI 0.02–0.87, p = 0.4), HTN (OR 0.13, 95% CI 0.06–2.04, p = 0.24), cardiovascular disease (OR 0.69, 95% CI 0.04–13.09, p = 0.8), smoking (OR 1.56, 95% CI 0.25–9.83, p = 0.63), and ex-smoking (OR 0.37, 95% CI 0.06–2.46, p = 0.3) (Table 4 and Fig. 1).

Table 4

Effect of risk factors affecting LIESWT results
MICD 3m	OR	95%CI for OR		p value
MICD 3m	OR	Lower	Upper	p value
Age	1.04	1.01	1.07	0.014
Uncontrolled DM	0.13	0.02	0.87	0.035
HTN	0.35	0.06	2.04	0.244
CVS	0.69	0.04	13.09	0.804
Smoker	1.56	0.25	9.83	0.635
Ex-smoker	0.37	0.06	2.46	0.305
LIESWT: Low intensity extracorporeal shockwave therapy. MICD: minimally important clinical difference. DM: diabetes mellitus. HTN: hypertension.

Due to the rising occurrence of ED in young men, affecting around 30% of those over the age of 40 ^[3], there is a growing interest in researching a curative therapy for this condition. Li-ESWT has gained increasing acceptance as a novel therapy for patients with ED in recent years. This therapy has shown considerable effectiveness in treating a range of medical conditions, including bone abnormalities and ischemic cardiomyopathy ^[6].

Li-ESWT seems to have a positive effect on the treatment of ED by stimulating the existing stem/progenitor cells, leading to increased cell growth and faster regeneration of penile tissues ^[7]. Concentrated shock waves induce micro-trauma (shear stress) in the targeted tissue, which stimulates the production of pro-angiogenic factors. As a consequence, the treated tissue undergoes neo-vascularization, leading to increased blood flow ^[8].

The effectiveness of the optimal treatment environment is still a subject of discussion, mostly due to the variations in treatment protocols stated, such as the kind of shockwave generator used, the energy flux density applied, the number of shockwaves administered each session, and the duration of the therapy. In our investigation, we utilized a concentrated SW generator to administer 5000 shocks each session, encompassing the entire penis, at an EFD of 0.1 mJ/mm2 for a duration of 6–12 weeks. These specific parameters were generally accepted and stated to provide more favorable outcomes when contrasted to other approaches ^[9].

The existing literature in this field provides strong evidence that researchers widely agree on the large favorable impact of LI-ESWT on improving the ED, as compared to sham treatment. Yuan & al. performed a systematic review of eight research investigations and found that Li-ESWT had a positive impact on participants' subjective ratings, particularly in the IIEF-EF domain. Additionally, Li-ESWT led to improvements in objective measures such as EHS and penile hemodynamics, specifically in regard to PSV ^[10]. In a comparable manner, Yao et al. conducted an analysis of 16 RCTs and found that therapy with Li-ESWT led to a rise in both the IIEF and the EHS among individuals with ED, particularly in those with moderate ED. Nevertheless, there was no significant improvement in the rate of positive reactions to the sexual experience profile (SEP2) and (SEP3) ^[11].

The present research focuses on three primary issues following Li-ESWT therapy for ED. First of all, it aims to determine which subgroup, based on the degree of ED, would have the most improvement. Additionally, a thorough assessment of hemodynamics of the penis, namely the measures of PSV and EDV. Furthermore, this work aims to examine the influence of several risk factors, such as age, HTN, DM, cardiovascular illnesses and smoking, on the effectiveness of Li-ESWT therapy.

In 2016, Kitrey and colleagues performed a work to examine the impact of Li-ESWT therapy on a group of 37 participants. 86% of the participants reported experiencing severe ED, with twenty participants (54%) stating that they were able to produce erections sufficient for penetration the vagina. In addition, the authors said that 15 individuals (40.5%) saw a positive change in their EF based on the MCID criteria following one month of follow-up after therapy with Li-ESWT ^[12]. In line with previous research, Kalyvianakis et al. conducted a study on 34 patients who reported moderate ED. They specifically investigated the potential benefits of Li-ESWT tissue regeneration characteristics for this subgroup of individuals. The results showed that 27 out of 34 patients (79%) achieved the MCID following undergoing Li-ESWT treatment. The follow-up period for assessing the outcomes was 3 months ^[13]. In addition, a study conducted by Zanaty et al. randomly assigned 50 individuals to be given either Li-ESWT therapy or oral on-demand Tadalafil 20 mg. The researchers found that the median change in IIEF-5 score was 5.2 in the Li-ESWT group contrasted with 7.4 in the Tadalafil group following one and a half months. Following a follow-up of 3 months, the median shift in IIEF-5 score was 6.4 in the Li-ESWT group and 5.6 in the Tadalafil group ^[14].

During our investigation, we observed substantial improvements in the patients' scores for the IIEF-EF domains, EHS, and achieving the MCID. These improvements were consistent with previous studies and was seen for up to 30 months following Li-ESWT therapy. One notable discovery was that those suffering from mild ED saw the most favorable results, as 71% of them sustained improvement until the last follow-up. Our findings revealed that a considerable percentage of patients with severe or moderate ED continued to experience the positive effects of Li-ESWT even after the follow-up period.

Although there is a large amount of literature accessible in the area, there is a scarcity of studies on the objective ultrasonography assessment of hemodynamics of penis following Li-ESWT therapy of ED. Kalyvianakis et al. conducted a double-blinded RCT including 46 men with vasculogenic ED. They evaluated the PSV at the onset of the work and three months following therapy. The findings revealed a noteworthy improvement in PSV, with a mean rise of 4.5 cm/sec in patients who underwent Li-ESWT ^[15]. In contrast, Yamaçake and colleagues documented a lack of improvements in Penile Duplex ultrasonography parameters when comparing sham therapy to actual treatment in a separate randomized controlled trial including 20 kidney transplant patients who were experiencing ED ^[16].

In a recent study conducted by ^[8], 30 individuals with moderate ED underwent Li-ESWT treatment. The researchers observed a substantial rise in the helicine arteries number identified by duplex imaging, as well as improvements in the penile brachial pressure index and PSV. These findings suggest an important rise in corporal neo-vascularization. The findings of our research not only confirmed the improvements of PSV following Li-ESWT, but also revealed a substantial reduction in EDV. This suggests that patients with minimal arterial insufficiency and/or modest venous sinusoidal leakage might regain the ability to have a normal EF. Therefore, the neo-angiogenesis enhances the flow of blood in the arteries and increases the pressure in the corporal tissue, overcoming the veno-occlusive dysfunction ^[17].

Additional study is required to assess the impacts of various factors of risk on Li-ESWT treatment, despite some existing advancements. Mason et al. found that Li-ESWT treatment may provide benefits for individuals with moderate and mild ED and properly controlled DM in the short term. Nevertheless, subjects with severe ED had less favorable responses. In addition, Li-ESWT treatment has been shown to alter a significant majority of non-responders to PDE5i into responders among diabetic males ^[18]. In a separate uncontrolled trial comprising 50 patients, ^[19] argued that individuals who reported ED alongside cardiovascular risk factors and/or well-managed HTN experienced a demonstrable advantage from Li-ESWT treatment in comparison to those without such conditions, albeit only in the short term.

In regard to the aforementioned issue, our research has also shown a notable inverse relationship among the attainment of the MICD and the occurrence of uncontrolled DM. Remarkably, we have also discovered a substantial correlation among increasing age and achieving MICD. The reason for this discovery may be attributed to the fact that penile ischemia alterations, which result in a shortage of smooth muscles, are the main cause of pathophysiological changes in older males ^[20], As a result, the older age group benefits the most from the neo-angiogenic consequences of Li-ESWT treatment.

The primary limitation of the work discussed here is the lack of a control arm. This may be due to the patients' unwillingness to undergo nonbeneficial sham treatment throughout the research period. Furthermore, the limited number of individuals with severe ED may impede the application of the findings within this specific group of participants. Moreover, we utilized a specific Li-ESWT protocol, hence our results can’t be generalized to the utilization of other Li-ESWT producing protocols or systems.

An important advantage of the present work is that we systematically included all types of individuals with ED in our study, and then we evaluated the data for each subgroup independently. Furthermore, to the best of our knowledge, this research is the first one to evaluate the long-term effects of Li-ESWT treatment on participants, with a potential follow-up period of up to 30 months. Furthermore, our research is unique in its description of a substantial impact on the parameters of EDV of the penile duplex as a result of improved blood flow in the penis. Our data includes an examination of a regression model to examine the impact of various risk variables on obtaining the MICD following Li-ESWT treatment. This is worth mentioning. Overall, we have expanded upon prior studies and included novel concepts that are regarded as a useful contribution to the area of LI-ESWT treatment for ED.

Regenerative therapy, particularly Li-ESWT therapy, is a compelling choice for treating ED because of its shown effectiveness. Our results indicate that Li-ESWT may have a lasting effectiveness in treating various levels of ED, as shown by the improvements in penile blood flow seen during the final follow-up. We acknowledge that the greatest advantage was attained among individuals with moderate and mild vasculogenic ED, especially individuals with properly controlled DM and increasing age. We suggest doing more research to evaluate the efficiency of Li-ESWT in treating severe ED, using bigger sample sizes. Furthermore, future studies ought to investigate the potential benefits of combining other regenerative therapy approaches.

LIESWT: Low intensity extracorporeal shockwave therapy

EF: erectile function

ED: erectile dysfunction

IIEF-EF: International Index of Erectile Function

EHS: Erection Hardness Scores

MICD: minimally clinically important difference

DM: diabetes mellitus

SD: standard deviation

IQR: interquartile range

PSV: Peak Systolic

Ethics approval and consent to participate:

This work approved from the Research Ethical Committee of Faculty of Medicine Cairo University (N-61-2023). A written informed consent from all participants had been taken.

Consent for publication:

Not applicable

Funding:

This study did not get any dedicated support from any governmental, commercial, or not-for-profit organizations.

Author Contribution

Author contributions: G.E.: conceptualization, data curation, formal analysis, investigation, methodology, writing–original draft, supervision, writing–review and editing.A.S.E.: conceptualization, data curation, investigation, methodology, writing–original draft, writing–review and editing.M.E.: data curation, investigation, writing–review and editing. M.A.A.: data curation, investigation, writing–review and editing. M.M.E. and M.A.F.E.: conceptualization, investigation, methodology, project administration, validation, supervision, writing–review and editing.M.W.R.: conceptualization, data curation, investigation, methodology, writing–original draft, writing–review and editing.

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No competing interests reported.

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The Efficacy of Low-Intensity Shock Wave Therapy based on the Stratification of Erectile Dysfunction Patients: A Long-term Follow-up

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