Low Intensity Shock Wave Treatment Research Articles

(138) Efficacy and Patient Satisfaction of Low-Intensity Shockwave Treatment for Erectile Dysfunction in a Retrospective Real-World Study in Japan

Abstract Introduction In Japan, the treatment options for erectile dysfunction (ED) are very restricted, if phosphodiesterase type 5 inhibitors (PDE5Is) are not effective. In this situation, low-intensity extracorporeal shockwave therapy (LiESWT) has gained increased attention as a new option for ED treatment in Japan. Objective To clarify the efficacy of low-intensity extracorporeal shockwave therapy for patients with erectile dysfunction, compare the efficacy between two types of lithotripters (ED1000 [focused type] and Renova [linear type]), and detect factors indicative of therapeutic gain with the treatment. Methods This retrospective study included 76 patients (52.8 +/- 11.7 years) treated by ED1000 (12 times over 9 weeks) and 484 patients (52.5 +/- 11.6 years) treated by Renova (4 times over 4 weeks). Age, sexual symptoms scores, and blood examinations were assessed. Efficacy was judged by improvement of the scores and patient satisfaction and compared between patients at 1 month after treatment with the lithotripters. Independent factors influencing efficacy by Renova were also assessed. Results Sexual symptom scores were improved significantly by both lithotripters, although the changes in the scores did not differ significantly between them. Efficacy rate as judged by patient satisfaction was 65.8% with the ED1000 and 71.1% with Renova, also without significant difference. Among several factors including age, sexual symptoms scores, endocrinological factors, metabolic factors, and the rate of phosphodiesterase type 5 inhibitor use, only age was found to be an independent factor influencing the efficacy of Renova. Conclusions We clearly showed the high efficacy of both lithotripters. Although the efficacy rate did not differ between them, we speculated that the fewer treatment sessions needed with the Renova versus the ED1000 would be a great advantage for patients. We also suggest that Renova should be recommended for patients younger than 70 years of age. Disclosure No.

Variations in Low Intensity Shockwave Treatment Protocols for Erectile Dysfunction: A Review of the Literature and Guide to Offering Treatment.

Low-intensity shockwave therapy (LiSWT) for erectile dysfunction (ED) continues to gain popularity in both clinical practice and the academic literature. The majority of trials and meta-analysis studies have shown LiSWT to be low risk with a trend toward positive improvements in International Index of Erectile Function (IIEF) scores. However, there is still debate over the clinical utility of LiSWT and there is no agreed upon optimal treatment protocol. In this review article we summarize published meta-analysis studies of LiSWT for ED, and review the treatment protocols from randomized sham-control trials published in the last 10 years. We found the most common device settings were an energy of 0.09 mJ/mm² and a frequency of 5 Hz. Shock number and location varied, but the most common protocol was 1,500 shocks per session, with 900 shocks to the penis (shaft, base, or hilum) and 600 shocks to the proximal corpora/crura. Protocols ranged from 4 to 12 treatment sessions. We also describe our institutional experience with LiSWT, including patient counseling and treatment protocol.

Management of Persistent Erectile Dysfunction after COVID-19 Infection: An 18-Month Follow-Up Case Report

The coronavirus disease 2019 (COVID-19) is an emerging pandemic caused by a novel coronavirus (SARS-CoV-2). Since December 2019 the new virus has spread all over the world and has become a major health problem also because of the public measures that could affect people’s sexual activity. We report a case of a 35-year-old married male admitted to the andrology outpatient clinic in July 2021 because of sudden onset erectile dysfunction (ED). The diagnostic workup showed no risk factor for ED, normal levels of testosterone, increased levels of endothelial dysfunction markers, such as CRP (C-Reactive Protein) and Endothelin-1, and reduced Vitamin D (VD) levels. Dynamic penile duplex ultrasound (D-PDU) revealed dysfunctional penile arterial flow. The five-item International Index of Erectile Function (IIEF-5) and the Short-Form Health Survey (SF-36) showed a reduction in all domain scores. The patient, initially unresponsive to the high dose oral phosphodiesterase 5 inhibitors (PDE-5is), was treated with vitamin-D and then submitted to LI-SWT (low intensity shockwave treatment), with a progressive clinical benefit at the 12-month follow-up. After 18 months, hormone levels persisted in normal ranges, with a consistent reduction in CRP and Endothelin-1. Additionally, IIEF-5, SF-36 and arterial flow significantly improved over the follow-up period. Thus far, the erectile function was restored and the patient is no more treated with PDE-5i.

Efficacy and patient satisfaction of low-intensity shockwave treatment for erectile dysfunction in a retrospective real-world study in Japan.

To clarify the efficacy of low-intensity extracorporeal shockwave therapy for patients with erectile dysfunction, compare the efficacy between two types of lithotripters (ED1000 [focused type] and Renova [linear type]), and detect factors indicative of therapeutic gain with the treatment. This retrospective study included 76 patients (52.8 ± 11.7 years) treated by ED1000 (12 times over 9 weeks) and 484 patients (52.5 ± 11.6 years) treated by Renova (4 times over 4 weeks). Age, sexual symptoms scores, and blood examinations were assessed. Efficacy was judged by improvement of the scores and patient satisfaction and compared between patients at 1 month after treatment with the lithotripters. Independent factors influencing efficacy by Renova were also assessed. Sexual symptom scores were improved significantly by both lithotripters, although the changes in the scores did not differ significantly between them. Efficacy rate as judged by patient satisfaction was 65.8% with the ED1000 and 71.1% with Renova, also without significant difference. Among several factors including age, sexual symptoms scores, endocrinological factors, metabolic factors, and the rate of phosphodiesterase type 5 inhibitor use, only age was found to be an independent factor influencing the efficacy of Renova. We clearly showed the high efficacy of both lithotripters. Although the efficacy rate did not differ between them, we speculated that the fewer treatment sessions needed with the Renova versus the ED1000 would be a great advantage for patients. We also suggest that Renova should be recommended for patients younger than 70 years of age.

Efficacy of Low-Intensity Extracorporeal Shock Wave Treatment in Erectile Dysfunction Following Radical Prostatectomy: A Systematic Review and Meta-Analysis.

Erectile dysfunction (ED) is a well-known complication of radical prostatectomy (RP). Oral 5-phosphodiesterase inhibitors are currently the most widely used penile rehabilitation treatment for ED following RP, but they are less effective than for those with general ED. Low-intensity extracorporeal shock wave treatment (LI-ESWT), causing a biological change that induces neovascularization, has recently been used as a treatment for ED. Therefore, we conducted a systematic review and meta-analysis to investigate the efficiency of LI-ESWT in ED following RP. PubMed, Embase, and the Cochrane Library were searched up until December 2021. The endpoint was the change in IIEF scores after LI-ESWT. Five papers (460 patients) were included in the final analysis. In IIEF scores performed 3–4 months after LI-ESWT, the group receiving LI-ESWT showed statistically significantly better results than the control (WMD = −2.04; 95% CI, −3.72 to −0.35; p = 0.02). However, there were a total of two studies that measured the results after 9–12 months. There was no statistical difference between the two groups (WMD = −5.37; 95% CI, −12.42 to 1.69; p = 0.14). The results of this analysis indicate that LI-ESWT showed a statistically significant effect on early recovery in penile rehabilitation of ED following RP. However, the level of evidence was low. Therefore, careful interpretation of the results is required.

Vascular and Erectile Tissue Health Changes Pre- and Post- Low Intensity Shockwave Treatment of the Erect Penis

ABSTRACT Introduction In 2010, low-intensity shockwave therapy (LiSWT) was first described for used on the flaccid penis as a novel and minimally invasive regenerative treatment for men with ED. A standardized protocol for use of LiSWT either in the flaccid or erect state has not yet been established. Erect penile LiSWT, in contrast to flaccid penile LiSWT, is performed with maximal penile shaft blood volume under conditions of greatest acoustic impedance. This minimizes transfer of shockwave energy though the erectile tissue enabling the greatest uptake of shockwave energy to the erectile tissue. We review our experience with LiSWT during pharmacologic erection. Objective Assess arterial blood flow and erectile tissue health parameters in ED patients prior to and following erect penile LiSWT to better document the hypothesized vascular/erectile tissue regenerative benefits associated with LiSWT in men with ED. Methods A retrospective chart review was performed. Prior to LiSWT (Urogold 100 MTS). ED patients underwent a baseline penile Grayscale/Doppler ultrasound (G/DUS) with Grade 3-4/4 erection following appropriate visual/pharmacologic stimulation. A B-mode ultrasound (Aixplorer 15.4 MHz transducer) was then performed at specific settings to avoid reader bias. This included 12 total axial images obtained at proximal, midshaft and distal dorsal penis at a fixed dynamic range of 70 dB with B-mode gain values of increased brightness (45%, 55%, 65%). The fourth image at each axial location was taken at a dynamic range of 49 dB and a B-mode gain value identified as providing the best discrimination between Grayscale black/white. Subsequently, in the erect shaft right/left sagittal planes, cavernosal artery peak systolic velocity (PSV) and end diastolic velocity (EDV) values were obtained. ED patients then underwent 6 erect penile LiSWT treatments over varying intervals. The protocol included: appropriate visual/pharmacologic stimulation to obtain Grade 3-4/4 erection, 600 shocks using a parabolic reflector probe (OP-155), energy flux density 0.13mJ/mm2, 3 Hz, membrane pressure 3, applied each to dorsal, ventral, right/left lateral erect penile shafts, and right/left erect crura (total shocks 3600, duration of LiSWT ∼ 28 minutes). Patients returning for erect penile LiSWT completed a PGI-I score. Approximately one month after the last erect penile LiSWT, a post-treatment penile G/DUS with Grade 3-4/4 erection was repeated resulting in 24 Grayscale images. Baseline and post-treatment G/DUS were de-identified and read by two experts reaching consensus concerning erectile tissue homogeneity/inhomogeneity on Grayscale with 0/3 no inhomogeneity, 1/3 mild inhomogeneity (<25% of cross-sectional area revealing hypo- or hyper-echoic regions), 2/3 moderate inhomogeneity (25% - 50%), and 3/3 severe inhomogeneity (>50%), respectively. PGI-I scores were also assessed and compared to ultrasound findings. Results 79 patients (mean age 44 +/- 21, range 19 – 85) met inclusion criteria. 53/79 (67%) had improved erectile tissue homogeneity post-LiSWT from baseline, 10/79 (13%) were unchanged, 15/79 (19%) worsened. Of the 53 patients with improved G/DUS findings, 40/53 patients (75%) rated PGI-I as improved. 37/53 (70%) patients had PSV increase and 18/53 (34%) had EDV decrease. Conclusions The mechanisms by which erect penile LiSWT improves erectile function, in part, involve enhanced erectile tissue homogeneity, increased cavernosal arterial PSV and decreased EDV. Disclosure No

Low-intensity shockwave treatment (LISWT) improves penile rigidity in eugonadal subjects with erectile dysfunction: a pilot study.

Since low-intensity shockwave treatment (LISWT) has putative effects on penile hemodynamics remodeling, the aim of this study was to evaluate any improvement of penile vascular flows after LISWT treatment in patients with erectile dysfunction (ED) and poor response to PDE5i. Twenty-one eugonadal patients with different ED severity underwent 6 weekly LISWT sessions (1500-4000 pulses) after 2 weeks withdrawal from PDE5i assumption. Once daily Tadalafil (2.5 mg daily) was reintroduced 4 weeks apart from LISWT termination and patients were evaluated at 1, 2 and 6 months follow-up (T1, T2, T6) by the International Index of Erectile Function-15 items questionnaire (IIEF-15) erectile function (EF) domain, Erection Hardness Score (EHS) and Global Assessment Questionnaires (GAQ). Basal Penile Color-Doppler Ultrasound parameters in the flaccid state (B-PCDU) were evaluated before, during and after interventional protocol. Mean EHS score improved in 35% of patients at T1, and in up to 50% of patients at T2 and T6 follow-up visits (P<0.05). We found 25% improvement of EF scores at T1 session, 43.75% at T2 and 62.5% at T6, respectively (P<0.05). No statistically significant differences in flow parameters, EF-domain and testosterone levels were found when baseline and last observation carried forward (LOCF) parameters were compared. The GAQ questionnaire scored higher satisfaction rates either at the end of the treatment (100%), or at LOCF (92.5%). Despite the study limitations with respect to B-PCDU in this setting, our results confirm a trend toward improvement of erectile questionnaire scores after LISWT with higher overall satisfaction rates among patients with ED. We conclude that LISWT may be an effective option in some difficult-to-treat patients with ED by improving the erectile response to PDE5i.

Low Intensity Shockwave Treatment Modulates Macrophage Functions Beneficial to Healing Chronic Wounds.

Extracorporeal Shock Wave Therapy (ESWT) is used clinically in various disorders including chronic wounds for its pro-angiogenic, proliferative, and anti-inflammatory effects. However, the underlying cellular and molecular mechanisms driving therapeutic effects are not well characterized. Macrophages play a key role in all aspects of healing and their dysfunction results in failure to resolve chronic wounds. We investigated the role of ESWT on macrophage activity in chronic wound punch biopsies from patients with non-healing venous ulcers prior to, and two weeks post-ESWT, and in macrophage cultures treated with clinical shockwave intensities (150–500 impulses, 5 Hz, 0.1 mJ/mm2). Using wound area measurements and histological/immunohistochemical analysis of wound biopsies, we show ESWT enhanced healing of chronic ulcers associated with improved wound angiogenesis (CD31 staining), significantly decreased CD68-positive macrophages per biopsy area and generally increased macrophage activation. Shockwave treatment of macrophages in culture significantly boosted uptake of apoptotic cells, healing-associated cytokine and growth factor gene expressions and modulated macrophage morphology suggestive of macrophage activation, all of which contribute to wound resolution. Macrophage ERK activity was enhanced, suggesting one mechanotransduction pathway driving events. Collectively, these in vitro and in vivo findings reveal shockwaves as important regulators of macrophage functions linked with wound healing. This immunomodulation represents an underappreciated role of clinically applied shockwaves, which could be exploited for other macrophage-mediated disorders.

Efficacy of penile low-intensity shockwave treatment for erectile dysfunction: correlation with the severity of cavernous artery disease.

We analyzed the efficacy of penile low-intensity extracorporeal shockwave treatment for erectile dysfunction (ED) combined with cavernous artery disease (CAD). ED was evaluated by the International Index of Erectile Function, subdividing patients into mild and moderate/severe forms. CAD was assessed using penile color Doppler ultrasonography. Patients (n = 111) with a positive outcome after treatment, based upon the minimal clinically important difference of the International Index of ED, were followed up for 3 months and 6 months. We found a significant mean increase in the index of erectile function, with an overall improvement in hemodynamic parameters of the cavernous artery. In particular, 93.9% of the patients with mild ED without CAD responded to treatment and 72.7% resumed normal erectile function. Only 31.2% of the patients with moderate/severe ED and CAD responded to treatment, and none resumed normal erectile function. All patients with mild ED and no CAD maintained the effects of therapy after 3 months, while no patients with moderate/severe ED and CAD maintained the benefits of treatment after 3 months. Thus, patients with mild ED and no CAD have better and longer lasting responses to such treatment, with a higher probability of resuming normal erectile function than patients with moderate/severe ED and CAD.

Penile low intensity shock wave treatment for PDE5I refractory erectile dysfunction: a randomized double-blind sham-controlled clinical trial.

Over the last decade, penile low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a promising alternative for the treatment of erectile dysfunction (ED). The aim of this trial is to assess the effect of electromagnetic LI-ESWT on the erectile function of vascular phosphodiesterase type 5 inhibitor (PDE5I) refractory ED patients. Randomized, double-blind, sham-controlled study. 76 patients with vascular PDE5I-refractory ED completed the study. 40 men were treated with LI-ESWT (1 session/week for 4weeks, 5000 shocks/session, 0.09mJ/mm2 energy density) and 36 were treated with a sham probe. Baseline and post-treatment (1, 3 and 6months) evaluations were performed using validated erectile function questionnaires (IIEF-EF, EHS, SEP2, SEP3 and GAQ1). The groups were compared using Mann-Whitney-Wilcoxon and chi-squared tests, with results considered statistically significant at p < 0.05. At the 3-month follow-up, median change in IIEF-EF score for active and sham groups was 3.5 (IQR 0-10) and - 0.5 (IQR - 11 to 1), respectively (p < 0.05). Six months after treatment, 52.5% of patients (21/40) in the active group and 27.8% of patients (10/36) in the sham group presented an EHS > 2 (p < 0.05). At the same evaluation, 40.0% (16/40) and 13.9% (5/36) of patients had positive answers to GAQ-1, in the treated and sham groups, respectively (p < 0.05). No adverse events were observed during the study. This study showed that penile electromagnetic shockwave therapy may improve erectile function, to a modest extent, on certain patients that do not respond to PDE5I; making it an alternative for vascular ED patients that reject more invasive therapies.

495 - Comparative analysis on the efficacy of low-intensity shock wave treatment (Li-ESWT) and phosphodiesterase 5 inhibitor (PDE5i) for the treatment of erectile dysfunction

495 - Comparative analysis on the efficacy of low-intensity shock wave treatment (Li-ESWT) and phosphodiesterase 5 inhibitor (PDE5i) for the treatment of erectile dysfunction

318 Retrospective Review of Improvement of Erectile Function after Low Intensity Shockwave Treatment with Urogold 100™

Erectile dysfunction (ED) can result from insufficient arterial blood inflow and/or from veno-occlusive dysfunction from reduced erectile tissue expandability secondary to erectile tissue fibrosis. Non-surgical strategies to manage ED in the United States (US) are primarily symptomatic-based, such as PDE5 inhibitors and/or intracavernosal injections. In Europe, disease modification strategies such as Low Intensity Shockwave Treatment (LiSWT) using energy levels 0.09 – 0.12 mJ/mm2 have shown, in multiple sham-controlled prospective studies, significant improvement in both ED outcome measures and blood inflow. The European Urological Association lists Li-SWT as a recognized ED treatment. The Urogold 100™ is an electrohydraulic shockwave device that generates energy levels such as 0.09 – 0.12 mJ/mm2 with a unique parabolic reflector. It is FDA-cleared for improved blood flow and connective tissue activation as non-significant risk in humans. The objective was to perform a single site retrospective chart review of the outcome of ED treatment with the Urogold 100™ shockwave device.

654 Long-term results of patient satisfaction after low-intensity shockwave treatment (Li ESWT) of erectile dysfunction and Peyronie's disease in an urological private practice

654 Long-term results of patient satisfaction after low-intensity shockwave treatment (Li ESWT) of erectile dysfunction and Peyronie's disease in an urological private practice

Low Intensity Shock Wave Treatment for Erectile Dysfunction—How Long Does the Effect Last?

We studied the long-term efficacy of penile low intensity shock wave treatment 2 years after an initially successful outcome. Men with a successful outcome of low intensity shock wave treatment according to the minimal clinically important difference on the IIEF-EF (International Index of Erectile Function-Erectile Function) questionnaire were followed at 6, 12, 18 and 24 months. Efficacy was assessed by the IIEF-EF. Failure during followup was defined as a decrease in the IIEF-EF below the minimal clinically important difference. We screened a total of 156 patients who underwent the same treatment protocol but participated in different clinical studies. At 1 month treatment was successful in 99 patients (63.5%). During followup a gradual decrease in efficacy was observed. The beneficial effect was maintained after 2 years in only 53 of the 99 patients (53.5%) in whom success was initially achieved. Patients with severe erectile dysfunction were prone to earlier failure than those with nonsevere erectile dysfunction. During the 2-year followup the effect of low intensity shock wave treatment was lost in all patients with diabetes who had severe erectile dysfunction at baseline. On the other hand, patients with milder forms of erectile dysfunction without diabetes had a 76% chance that the beneficial effect of low intensity shock wave treatment would be preserved after 2 years. Low intensity shock wave treatment is effective in the short term but treatment efficacy was maintained after 2 years in only half of the patients. In patients with milder forms of erectile dysfunction the beneficial effect is more likely to be preserved.

Low-intensity extracorporeal shock wave therapy of vasculogenic erectile dysfunction - three-week treatment in a cohort of North Italian patients

Introduction/Objective. Although phosphodiesterase 5 (PDE 5) inhibitors represent the gold standard for medical treatment of erectile dysfunction (ED), they are not curative. Over the recent years, low-intensity extracorporeal shock wave therapy (LI-ESWT) has been proposed as a valid non-invasive therapy approach for ED. The aim of our work is to assess the shortened, three-week low-intensity extracorporeal shock wave therapy of vasculogenic ED. Methods. The study involved 32 patients with an International Index of Erectile Function (IIEF) score between 5 and 20, and whose vasculogenic ED had been proven through Doppler ultrasound. All the patients had a washout period of one month after previous therapy and agreed to discontinue the PDE5-I therapy during the follow-up. The LI-ESWT was applied for three weeks, twice weekly, without repeating. The patients were evaluated at baseline, after one, three, and six months with the IIEF, Doppler ultrasound, and the Beck Depression Inventory. Results. All investigated parameters (International Index of Erectile Function, Beck Depression Inventory and penile Doppler ultrasound parameters) showed statistically significant improvement just one month after the treatment, compared to pre-treatment values, in all investigated domains. The international index of erectile function passed from baseline values of 12.75 ? 4.62 to 14.87 ? 5.04 at one month after treatment (p &lt; 0.01). This trend remained positive in IIEF and all the parameters tested at the three-month and six-month follow-up. Conclusion. The shortened three-week low-intensity shock wave treatment of vasculogenic erectile dysfunction proved to be clinically effective.

The effect of low intensity shockwave treatment (Li-SWT) on human myoblasts and mouse skeletal muscle

BackgroundTransplanting myogenic cells and scaffolds for tissue engineering in skeletal muscle have shown inconsistent results. One of the limiting factors is neovascularization at the recipient site. Low intensity shockwave therapy (Li-SWT) has been linked to increased tissue regeneration and vascularization, both integral to survival and integration of transplanted cells. This study was conducted to demonstrate the response of myoblasts and skeletal muscle to Li-SWT.MethodPrimary isolated human myoblasts and explants were treated with low intensity shockwaves and subsequently cell viability, proliferation and differentiation were tested. Cardiotoxin induced injury was created in tibialis anterior muscles of 28 mice, and two days later, the lesions were treated with 500 impulses of Li-SWT on one of the legs. The treatment was repeated every third day of the period and ended on day 14 after cardiotoxin injection.. The animals were followed up and documented up to 21 days after cardiotoxin injury.ResultsLi-SWT had no significant effect on cell death, proliferation, differentiation and migration, the explants however showed decreased adhesion. In the animal experiments, qPCR studies revealed a significantly increased expression of apoptotic, angiogenic and myogenic genes; expression of Bax, Bcl2, Casp3, eNOS, Pax7, Myf5 and Met was increased in the early phase of regeneration in the Li-SWT treated hind limbs. Furthermore, a late accumulative angiogenic effect was demonstrated in the Li-SWT treated limbs by a significantly increased expression of Angpt1, eNOS, iNOS, Vegfa, and Pecam1.ConclusionTreatment was associated with an early upregulation in expression of selected apoptotic, pro-inflammatory, angiogenic and satellite cell activating genes after muscle injury. It also showed a late incremental effect on expression of pro-angiogenic genes. However, we found no changes in the number of PAX7 positive cells or blood vessel density in Li-SWT treated and control muscle. Furthermore, Li-SWT in the selected doses did not decrease survival, proliferation or differentiation of myoblasts in vitro.

PS-07-008 Exploring the number of low intensity shock wave treatment (LiSWT) sessions needed in patients with vasculogenic erectile dysfunction (ED): 6 vs 12 sessions in a 6 weeks period

PS-07-008 Exploring the number of low intensity shock wave treatment (LiSWT) sessions needed in patients with vasculogenic erectile dysfunction (ED): 6 vs 12 sessions in a 6 weeks period

252 - Low intensity shock wave treatment (LiSWT) improves erectile function in a session-dependent manner: Results of a randomized trial comparing two treatment protocols

252 - Low intensity shock wave treatment (LiSWT) improves erectile function in a session-dependent manner: Results of a randomized trial comparing two treatment protocols

Re: Penile Low Intensity Shock Wave Treatment is able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study

Re: Penile Low Intensity Shock Wave Treatment is able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study

HP-01-001 Low-intensity shockwave treatment for ED patients at least one year after radical prostatectomy - phase IIb study

HP-01-001 Low-intensity shockwave treatment for ED patients at least one year after radical prostatectomy - phase IIb study