Low-intensity Shock Research Articles

MODELING OSTEOCYTE UNDER SHOCK-WAVE THERAPEUTIC LOADING

Dental implants have substantial significance in modern dentistry, but their osseointegration stage remains the most crucial and time-consuming step for compensating for a lost tooth. One promising approach to improve osseointegration rates is the use of extracorporeal shock wave therapy, which has shown efficacy in treating fractures, bone defects, and bone tissue regeneration in surgical and arthroplasty procedures. To comprehend the potential of shock wave therapy in accelerating implant osseointegration, it is crucial to investigate the influence of mechanical loading on ossification processes of varying scales objectively. This study aims to study numerically the effects of low-energy shock wave therapy at different intensities on the mechanical response of a single osteocyte, the principal bone cell that corresponds to microscale of bone tissue. The investigation employs the method of movable cellular automata for modeling. The computer simulation results and analysis based on mechanobiological principles indicate that low-intensity shock wave loading creates conditions for intramembranous ossification, whereas high-intensity shock wave exposure creates conditions for endochondral ossification.

Cellular regenerative therapy in stress urinary incontinence: new frontiers?-a narrative review.

Even if treatment with stem cells has been shown to be safe and effective in many patients with stress urinary incontinence (SUI), there is still room for improvement using other regenerative medicine alternatives. Since the beneficial effects of stem cells are probably mediated by secretion of factors rather than by the cells themselves there is a good rationale for further exploring the therapeutic effects of the secretome and/or its components. However, homing factors such as stromal derived growth factor 1 (SDF-1; CXCL12), stimulation of stem cell growth and stem cell mobilization in vivo using low intensity shock wave therapy (Li-ESWT) or regenerative electrical stimulation (RES), are also promising approaches. A literature search was performed based on PubMed, Scopus and Google Scholar. The search criteria included original basic science articles, systematic reviews and randomized control trials. All studies were published between 2000 and 2023. Selected, peer-reviewed studies were further analyzed to identify those of relevance. Keywords searched included: "female stress incontinence", "homing factors", "CXCL12", "secretome", "low intensity shockwave therapy" and "regenerative electrical stimulation". The peer-reviewed publications on the key word subjects that contained a novel addition to the existing body of literature were included. There is evidence from studies on non-human primates (NHPs) with experimental urinary sphincter injury that CXCL12 can restore sphincter structure and function. Studies with homing factors in human patients with SUI are still to be performed. A large number of clinical studies on the use of secretome or secretome products from mesenchymal stem cells (MSCs) on indications other than human SUI are already available. However, controlled clinical trials on patients with SUI, have to the best of our knowledge, not yet been performed. Also, RES has not been studied in patients with SUI. In contrast, there is clinical evidence that Li-ESWT may improve female SUI. Treatment with homing factors, MSC secretome/secretome components, Li-ESWT and RES are promising frontiers in the treatment of human SUI caused by sphincter damage.

Successful treatment of hard flaccid syndrome with multimodal therapy: a case report study.

Our article outlines a case study assessing the use of low-intensity shock wave therapy (LiSWT) for managing Hard Flaccid Syndrome (HFS). Given the absence of standardized treatments for HFS, LiSWT could serve as an additional tool in the treatment arsenal. The case involved a 36-year-old male presenting HFS, low libido, chronic pain, and erectile dysfunction. Treatment comprised phosphodiesterase type 5 inhibitor (PDE5-I), physical therapy, and LiSWT. Following six sessions, the patient experienced regression of bothersome symptoms and improved erections. A 2-year follow-up revealed sustained symptom relief. LiSWT presents a non-invasive means of inducing mechanical stress and microtrauma in targeted tissues, fostering neovascularization and potentially enhancing blood supply. The integration of LiSWT with PDE5-I and physical therapy suggests a potential avenue for effective HFS management. Nevertheless, further systematic research is essential to validate the therapy's benefits and assess, if any, potential drawbacks.

(268) Intracavernous Prostaglandin Injection as a Predictor and Effectiveness Measure for LISWT Sessions in ED Patients: A Single Urologist's Experience

Abstract Introduction In recent years, therapeutic approaches for treating vasculogenic Erectile Dysfunction (ED) have evolved, with Low Intensity Shock Wave Therapy (LISWT) emerging as a promising modality. Objective To objectively evaluate the efficacy of LISWT for ED patients and to predict the required number of sessions, we examined the effects of administering up to 10 mcg of intracavernous alprostadil injections both before and after treatment Methods 85 vasculogenic ED patients (Average age: 57); 33 with mild to moderate ED and 52 with moderate or severe ED. Intracavernous injection (ICI) of ≤10 mcg of alprostadil was given before LISWT and one month post-treatment. Depending on ICI response, patients underwent either six (Erection Hardness Score (EHS) ≤3) or four (EHS=4) weekly LISWT sessions using PiezoWave2 from Richard WOLF. LISWT Parameters: 0.16mj/mm2 energy flux density, 8 Hz frequency, 10mm wave focus penetration depth, and 6000 shocks per session distributed among the two crura of the penis (2000 shocks), dorsum penis (2000 shocks), and lateral penis (2000 shocks). Results 33 patients showed a robust response to the 10mcg ICI and were treated with four LISWT sessions. 52 patients exhibited a partial response to the 10mcg ICI, necessitating six LISWT sessions. 78.6% (26 out of 33) of the patients who initially responded well to 10 mcg ICI had a consistent response to 8 mcg ICI; 63.6% (33 out of 52) of those with a partial initial response to 10 mcg ICI demonstrated an improved reaction to the same dosage post-treatment (table 1) (fig. 1). No complications were reported from the ICI. Conclusions Intracavernous prostaglandin injection can serve as a predictor for the required number of LISWT sessions and can objectively gauge the treatment's effectiveness in ED patients. Further randomized studies, incorporating parameters such as EHS, IIEF, and the ICI dosage, are recommended to validate this method's feasibility Disclosure No.

(281) Low-Intensity Shockwave Therapy Combined with Tadalafil 5mg Daily has Better Efficacy for Mild and Moderate Erectile Dysfunction: The Preliminary Results of a Multicenter Clinical Study in China

Abstract Introduction Most clinical studies have demonstrated that low-intensity extracorporeal shockwave therapy (Li-ESWT) can improved erectile function in patients with erectile dysfunction (ED). The EAU guideline recommended to use Li-ESWT for mild vasculogenic ED patients. However, the therapeutic advantages of Li-ESWT combined with phosphodiesterase type 5 inhibitors (PDE5i) have not been explored clearly in clinical practice for mild and moderate ED patients. Objective To compare the therapeutic effects of Li-ESWT and Li-ESWT combined with PDE5i in mild and moderate ED patients with 8≤IIEF-5≤16 from a multicenter clinical study in China. Methods Patients with ED which IIEF-5 score is less than 22 and aged 18–60 years old were enrolled from three clinical centers from Jun. 2019 to Mar. 2023. The demographic data, International Index of Erectile Function-5 (IIEF-5), erectile hardness score (EHS) and self-reported symptom questions were collected. Patients were treated by a linear low-energy shock waves generator (Renova). Low-intensity shock wave (energy density of 0.09mJ/mm2) treatments were applied (once a week, 4 weeks in total, 5000 shocks each time). Patients in Li-ESWT combined with PDE5i group took 5mg of tadalafil once a day for one continuous month during ESWT. Comparative analyses of pre- and post-treatment and intergroup were used for statistics. Results In total, 42 ED cases (37.43±11.86 years) in Li-ESWT group and 116 cases (37.41±10.14 years) in combined group were enrolled for analysis. The IIEF-5 score and EHS in both groups were significantly improved after 1 month treatment (p<0.01). Compared with Li-ESWT group, patients in combined group significantly had higher self-reported efficiency (61.2% vs. 47.6%, p=0.013), IIEF-5 scores (15.34±7.15 vs. 13.96±7.71, p=0.039) and EHS (2.85±0.82 vs. 2.69±0.89, p=0.050). In the mild and moderate ED (with 8≤IIEF-5≤16) sub-group, 30 ED cases (36.81±10.99 years) in Li-ESWT group and 96 cases (36.80±10.69 years) in combined group were enrolled for analysis. The combined regimen showed better therapeutic advantages, including effective parameters IIEF-5(14.50±6.74 vs. 12.87±8.54, p=0.040), EHS (2.85±0.75 vs. 2.81±0.67, p=0.046) and self-reported efficiency (64.2% vs. 54.1%, p=0.001). Conclusions Li-ESWT can effectively improve erectile function in this multicenter clinical study in China, and the combination of Li-ESWT with daily use PDE5i had a better therapeutic effect on Chinese ED patients, especially on mild and moderate ED. Long-term follow-up with large sample study need to be developed for exploring the optimal therapeutic regimen. Disclosure No.

Regenerative Therapy in Erectile Dysfunction: A Survey on Current Global Practice Trends and GAF Expert Recommendations.

This study aimed to examine current global practices in regenerative therapy (RT) for erectile dysfunction (ED) and to establish expert recommendations for its use, addressing the current lack of solid evidence and standardized guidelines. A 39-question survey was developed by senior Global Andrology Forum (GAF) experts to comprehensively cover clinical aspects of RT. This was distributed globally via a secure online Google Form to ED specialists through the GAF website, international professional societies, and social media, the responses were analyzed and presented for frequencies as percentages. Consensus on expert recommendations for RT use was achieved using the Delphi method. Out of 479 respondents from 62 countries, a third reported using RT for ED. The most popular treatment was low-intensity shock wave therapy (54.6%), followed by platelet-rich plasma (24.5%) and their combination (14.7%), with stem cell therapy being the least used (3.7%). The primary indication for RT was the refractory or adverse effects of PDE5 inhibitors, with the best effectiveness reported in middle-aged and mild-to-moderate ED patients. Respondents were confident about its overall safety, with a significant number expressing interest in RT's future use, despite pending guidelines support. This inaugural global survey reveals a growing use of RT in ED treatment, showcasing its diverse clinical applications and potential for future widespread adoption. However, the lack of comprehensive evidence and clear guidelines requires further research to standardize RT practices in ED treatment.

Platelet-rich plasma intracavernosal injections for the treatment of primary organic erectile dysfunction: a systematic review and meta-analysis of contemporary controlled studies.

We aim to summarize the latest evidence on platelet-rich plasma (PRP) intracavernosal injections efficacy in men affected by primary organic erectile dysfunction (ED). We reviewed the literature for randomized controlled trials (RCTs) or prospective and retrospective comparative studies evaluating PRP alone or in combination for ED treatment. A comprehensive search in PubMed, Scopus, Web of Science, and ClinicalTrials.gov was performed for English language full-text articles or conference abstracts. A qualitative and quantitative data synthesis was provided. Overall, seven records were included: three RCTs evaluated PRP vs. placebo, one study separately tested PRP and low-intensity shock wave therapy (Li-SWT), three studies compared Li-SWT or low-intensity pulsed ultrasound alone with their combination with PRP. Of 641 included patients, 320 received PRP. Despite the heterogeneity among inclusion criteria, dose and protocol of PRP administration, and outcomes measured, most studies independently reported better sexual outcomes in patients who received PRP, without significant severe side effects. In meta-analysis, where only placebo-controlled studies were included, patients treated with PRP showed higher International Index of Erectile Function (erectile function domain) score compared to patients who received placebo: pooled mean difference (95% Confidence Interval) of 2.99 (1.86, 4.13) after 1 month (209 patients) vs. 2.85 (1.61, 4.09) after 3 months (204 patients) vs. 3.21 (1.82, 4.60) after 6 months (199 patients) of follow-up. In men affected by primary organic ED, PRP intracavernosal injections demonstrated an objective improvement or at least a tendency in erectile function recovery. Patient numbers, and the short-term follow-up may limit the generalizability of these observations. High quality, large-scale, and standardized controlled trials are needed before recommending its definitive use in clinical practice.

Patients' attitude with surgery for Peyronie's disease: results from a multicentric European study.

Despite the existence of conservative therapies for Peyronie's disease (PD), surgery is commonly utilized for the treatment of bothersome curvatures due to its potential effectiveness, although it carries intrinsic risks and may not universally lead to satisfactory outcomes. To explore the rate and factors influencing patients' willingness to undergo surgery for PD. Data were prospectively collected in 5 European academic centers between 2016 and 2020. Data included age, time from PD onset, penile pain, curvature degree, difficulty at penetration, hourglass deformity, erectile dysfunction (ED), and previous treatments. All patients were offered conservative treatments, either medications or injections. Tunical shortening or lengthening procedures were offered as an alternative to conservative treatments, when indicated. Penile prosthesis was offered to those with concomitant ED. Patients' attitudes with surgery were recorded. Logistic regression analyses tested the profile of patients who were more likely to be willing to undergo surgery. Patients' willingness to undergo surgery for PD. This study included 343 patients with a median age of 57.3years (IQR, 49.8-63.6) and a median penile curvature of 40.0° (IQR, 30.0°-65.0°). Overall, 161 (47%) experienced penetration difficulties and 134 (39%) reported ED. Additionally, hourglass deformity and penile shortening were reported by 48 (14%) and 157 (46%), respectively. As for previous treatments, 128 (37%) received tadalafil once daily; 54 (16%) and 44 (13%), intraplaque verapamil and collagenase injections; and 30 (9%), low-intensity shock wave therapy. Significant curvature reduction (≥20°) was observed in 69 (20%) cases. Only 126 (37%) patients were open to surgery for PD when suggested. At logistic regression analysis after adjusting for confounders, younger age (odds ratio [OR], 0.97; 95% CI, 0.95-1.00; P = .02), more severe curvatures (OR, 1.04; 95% CI, 1.03-1.06; P < .0001), and difficulty in penetration (OR, 1.88; 95% CI, 1.04-3.41; P = .03) were associated with a greater attitude to consider surgical treatment. The need for effective nonsurgical treatments for PD is crucial, as is comprehensive patient counseling regarding surgical risks and benefits, particularly to younger males with severe curvatures. Main limitations are the cross-sectional design and the potential neglect of confounding factors. Patients with PD, having a lower inclination toward surgery, emphasize the need for effective nonsurgical alternatives and accurate counseling on the risks and benefits of PD surgery, particularly for younger men with severe curvatures.

Efficacy of low-intensity shockwave therapy with different tadalafil regimens in patients with PDE5 inhibitor-resistant erectile dysfunction: a retrospective cohort study.

Currently, there is a lack of research comparing tadalafil treatment protocols recommended during low-intensity shock wave therapy (LI-SWT) for patients with erectile dysfunction (ED) who are unresponsive to phosphodiesterase type 5 inhibitors (PDE5i). The objective of this study is to compare the efficacy of only LI-SWT versus LI-SWT plus 5mg tadalafil daily versus LI-SWT plus 20mg tadalafil alternate-day in PDE5i -resistant ED. MATERıALS AND METHODS: In this study, a cohort of 105 patients with PDE5i-resistant ED was recruited and divided into three groups labeled as A (only LI-SWT), B (LI-SWT plus 5mg tadalafil daily), and C (LI-SWT plus 20mg tadalafil alternate-day), comprising 27, 42, and 36 patients, respectively. The patients' International Index of Erectile Function-5 (IIEF-5) scores and the Erection Hardness Score (EHS) were evaluated at the baseline, three months and six months following the treatment. After three months post-treatment, the IIEF-5 scores in group A, B, and C increased by 4.1 ± 0.6, 7.3 ± 0.6, and 8.2 ± 0.6, respectively. These improvements were maintained at six months with IIEF-5 scores increasing by 3.7 ± 0.6, 7.3 ± 0.6, and 8.5 ± 0.7 in groups A, B, and C, respectively. At 3 and 6months post-treatment, groups B and C showed significant improvement in IIEF-5 scores and EHS values compared to group A (p < 0.001). The rate of patients with EHS ≥ 3 and IIEF-5 ≥ 17 was significantly higher in groups B and C compared to group A, while there was no significantly different between groups B and C. CONCLUSıON: In patients with PDE5i-resistant ED, PDE5i combined with LI-SWT is superior to LI-SWT monotherapy. The statistical analysis failed to demonstrate any difference between two distinct tadalafil regimens when administered with LI-SWT treatment.

(382) Trimodal Therapy for Erectile Dysfunction: Combination of Low-intensity Shock Waves, Platelet Rich Plasma (PRP) Injections and Vacuum Erectile Device Physiotherapy

Abstract Introduction Nowadays it is proved that low intensity shockwave therapy (LISW) have a positive effect in men with erectile dysfunction (ED). Platelet rich plasma (PRP) as well is used to treat ED. PRP contains many growth factors, such as IGF-1, BDNF and VEGF play a significant role in neural regeneration and up-regulation nNOS, as well as in the recovery of erectile function. Vacuum erectile device is used as physiotherapy to treat many penile disease. Objective The goal of our study is to investigate the efficacy of this trimodal treatment (Rigenerection ®) to treat ED Methods This prospective, randomized, controlled, interventional study enrolled 150 pts and randomly divided in two groups: Group A receiving LISW alone (1 weekly sessions) for 6 weeks and Group B receiving LISW + PRP (1 shot a week per 6 weeks) + Vacuum erectile device physiotherapy (15 minutes/daily per 3 months). Main outcome measures were: erectile function (evaluated through the IIEF5 questionnaire) and the peak systolic velocity (PSV) of the cavernosal artery (evaluated through color Doppler ultrasonography). Follow-up was at 3 months. The Mann-Whitney and Wilcoxon tests with a p&amp;lt;0.05 where used to analize the data. Results In both groups, at 3 months follow-up, mean IIEF score and mean PSV ameliorated significantly. Intergroup analysis revealed a statistically significant higher mean IIEF score and PSV increase in patients receiving the trimodal treatment (p&amp;lt;0.03; p&amp;lt;0.001 respectively). Group A: IIEF score from a baseline of 14.2 to 17.9 at 3 months. PSV from 24.4 +/− 12.4 at baseline to 33.8 +/− 8.2 at 3 months. Group B: IIEF score from a baseline of 13.8 to 21.4 at 3 months. PSV from 27.3 +/− 42.6 +/− 7.3 at 3 months. Conclusions The trimodal therapy proved to be a valid tool in the treatment od ED. The combination of these procedures leads to better outcomes compared with the only therapy with LISW. Disclosure No

(432) Efficacy of Low-Intensity Shockwave Therapy on Hard Flaccid Syndrome: Initial Report of Three Cases

Abstract Introduction Hard flaccid syndrome (HFS) is characterized by chronic pain in the penis and perineum and firmness or rigidity of the penis even while not erect and may have a devastating impact on patient sexual quality of life. Although this syndrome has been discussed in myriad patient forums, there is no established evidence-based definition nor specific standard established treatment modalities in the literature. Current treatment options may include a combination of medical pain management, pelvic floor physical therapy, biofeedback, and stress reduction. In patients with other chronic pain conditions who fail traditional therapies, low-intensity shock wave therapy (LiSWT) has been increasingly utilized as management with positive response. We report a series of three patients with managed with LiSWT. Objective To report our initial experience of men with HFS managed with LiSWT. Methods Three patients, aged 36, 24, and 20 diagnosed with HFS were treated with LiSWT for a course of six sessions. In each session, LiSWT settings were: energy flux density of 0.13 mJ/mm2 and frequency of 3 Hz. While penis was held in stretched position, 600 shocks were delivered to each of the dorsum, left, ventral, and right aspects of penis along the shaft. The scrotum was then held up, and 600 shocks were delivered to each of the right and left crural areas, adding up to 3600 total number of shocks that were allocated evenly. All patients answered a questionnaire to assess improvement in symptoms after completion of the treatment sessions (Table 1). Results All patients reported initially alleviated symptoms after 3 treatment sessions, particularly with respect to penile rigidity in the flaccid state. Patient 1 elected for a combination of LiSWT and tadalafil. 5 months after treatment completion, Patient 1 has had complete resolution of HFS symptoms. Patient 2 had no response with tadalfil alone before he elected for LiSWT only, and patient 3 opted for LiSWT alone. After each LiSWT session, patient 2 reported relieved symptoms for 3-4 days, while patient 3 reported significant improvement lasting for 24 hours. Both patients 2 and 3 reported gradually returning to their pre-treatment baseline in 5 months’ follow-up. Conclusions While HFS is becoming increasingly recognized amongst sexual medicine clinicians, there are currently no established efficacious treatment options. LiSWT shows potential as a treatment modality and may have increased efficacy if used in combination with PDE5 inhibitors, as demonstrated in this pilot study. Nevertheless, a larger case series is necessary to establish LiSWT as a standardized treatment option and may require a more comprehensive approach to properly manage this condition. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

(379) The Effectiveness of Low-intensity Shock Wave Therapy as an Emerging Non-invasive Management of Erectile Dysfunction Among Adult Males: A Systematic Review and Meta-analysis

Abstract Introduction Erectile dysfunction (ED) is the penile inability to sustain erection necessary for sexual function due to physiological, psychological, or emotional factors. While the WHO promotes sexual health for all individuals, ED remains a major influence in attaining satisfying sexual performance among the aging population of men. The effective management and treatment of ED has been primarily pharmacologic and the research to support other non-invasive management such as low-intensity shock wave therapy (Li-ESWT) is apparently limited. Objective This systematic review and meta-analysis of available randomized controlled studies investigates the effectiveness of Li-ESWT for ED among adult males based on the International Index of Erectile Dysfunction (IIEF) score. Methods The literature search was conducted using the PubMed database. The search was limited to randomized controlled trials on the effectiveness of Li-ESWT on ED, written in English from Medline and Nursing journals, and are publicly accessible without monetary cost published from 2012 to 2020. PRISMA guidelines were used as framework for literature search and review. The RevMan software was utilized for data collection and analysis. A fixed effect model was used in the meta-analysis. Results A total of 19 randomized controlled trials were reviewed of which three were included in this meta-analysis. There were total of 120 participants with overall mean age ranges from 41 to 61 years, 61 were enrolled in Li-ESWT group and 59 in the sham group. The heterogeneity of the data shows □2 = 7.70, df= 2, (p= &amp;lt;0.05); I2 = 74%, the overall effect is Z= 3.35, p = &amp;lt;0.05. This meta-analysis demonstrates that the control group (sham) was favored over the experimental group (Li-ESWT) (SMD= 0.64, 95% CI, [0.27, 1.02]) based on the mean IIEF score at the end of the studies. Conclusions The use of shock wave therapy in addition to pharmacologic and non-invasive modalities in the treatment and management of ED is promising. However, while the dearth of randomized clinical trials using Li-ESWT for ED management is evident, the decision to proceed with treatment is based on the informed and collaborative decision between the urologist and the patient. This review highlights that sham therapy is not inferior to Li-ESWT treatment. The urologists may consider the cost, adverse effects, time, and effort of using Li-ESWT provided that there is no significant difference in the effectiveness of Li-ESWT compared with sham treatment. Further research is needed to support effectiveness and safety of Li-ESWT in managing ED compared to current pharmacologic regimen. Disclosure No

Regenerative therapies for erectile dysfunction: the influence of direct-to-consumer marketing on patient interest.

Despite a lack of evidence, a number of "regenerative" therapies have become popularized treatments for erectile dysfunction (ED). Platelet-rich plasma (PRP) injections and shockwave therapy have received significant attention through direct-to-consumer marketing and are advertised as viable alternatives to guideline-backed therapies. Additionally, focused low-intensity shock wave therapy (LiSWT) has become conflated with acoustic or radial wave therapy (rWT), although their mechanism of wave generation and tissue penetration is distinct. GAINSWave, a marketing platform for acoustic wave therapy, has also pervaded the marketplace. We aim to evaluate the relative impact of direct-to-consumer marketing of shockwave therapy and PRP by analyzing the quantity of Google internet search queries for selected regenerative and guideline-backed non-regenerative therapies for ED. National Google Search trends in the United States (www.google.com/trends) were analyzed to characterize interest in different forms of therapy for ED. Search trends for PRP, LiSWT (and various iterations), intracavernosal injections (ICI), intraurethral injections (IU), vacuum erectile device (VED), and GAINSWave were analyzed. Monthly search data were compiled over multiple years, ending at 2/28/2020, just before the COVID-19 pandemic and state of emergency in the United States. Macro-level changes in public interest were quantified using yearly averages. Patterns in Google Search interest in PRP and LiSWT increased respectively by 3-fold and 275-fold over the decade, representing a larger share of Google Searches by 2020. Trends in Google Search interest in selected types of shockwave therapy for ED also show that queries for GAINSWave commanded public interest, increasing by 219-fold from 2016 to 2020. Regenerative therapies for ED have produced interest surpassing other adjunct guideline-backed therapies, despite receiving the designation of "experimental" or "investigational" therapies. The establishment of GAINSWave also constitutes an inflection point for the whole shockwave market: searches for shockwave therapy increased by 782% between 2016 and 2020. Direct-to-consumer marketing of PRP and shockwave therapy has upturned the customary role of physicians in counseling patients about evidence-based therapies for ED. This increase in public interest in GAINSWave emphasizes its success as a marketing platform. The urological community should consider strategies to address misinformation, such as search-engine optimization, social media, and educational outreach.

Re: The Effect of Low-intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-blind, Randomized, Sham-controlled Clinical Trial

Re: The Effect of Low-intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-blind, Randomized, Sham-controlled Clinical Trial

Review Efficacy and theoretical basis of low-intensity shock wave therapy in the management of different forms of wound healing – own experiences and a review of the literature

Objectives: Wound healing is a complex process that involves inflammation, proliferation, and tissue remodeling to restore damaged tissue integrity. Chronic wounds and ulcers, with incomplete healing and a high risk of recurrence, pose significant challenges to conventional treatments. Extracorporeal Shock Wave Therapy (ESWT) has emerged as a promising wound healing therapy. Material and Methods: In this review, we summarize the current state of ESWT for wound management based on personal experiences and a comprehensive literature review. Among 184 data sources from 1990 to 2022, 19 relevant publications were identified, including systematic reviews, meta-analyses, and clinical studies applying focused and radial ESWT for various wound types. Results: ESWT's mechanism of action involves generating focused or radial shock waves, stimulating tissue repair through angiogenesis, fibroblast proliferation, and collagen expression. Data extracted from systematic reviews showed positive outcomes for wound healing, healing rate, and wound area reduction for chronic wounds such as diabetic foot ulcers, pressure ulcers, and venous ulcers. Studies on radial ESWT revealed similar positive effects in pain reduction and wound healing, with no serious adverse events reported. ESWT exhibited a well-tolerated safety profile, with minor and transient side effects such as reddening, swelling, and mild pain at the treatment site. Comparatively, Hyperbaric Oxygenation Therapy (HBO), an alternative treatment option, showed unique adverse events not observed with ESWT. Our evaluation confirms ESWT as a safe and effective treatment for wound management, offering hope for patients with chronic wounds or ulcers. Conclusions: ESWT presents a compelling non-invasive and safe treatment option for various wound healing challenges, improving outcomes for patients with chronic wounds and ulcers. This review highlights the potential of ESWT as an advanced wound healing therapy, complementing conventional approaches. Further studies should explore potential differences between focal and radial ESWT for wound healing.

The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial.

We conducted the first double-blind, randomized, sham-controlled trial evaluating the efficacy and safety of low-intensity shock wave therapy (LiST) exclusively in patients with moderate erectile dysfunction. Seventy patients were randomized to 12 sessions of LiST (35) or sham therapy (35) twice weekly. Patients were evaluated at 1 and 3 months after completion of treatment. The proportion of participants attaining minimal clinically important difference (MCID) in the International Index of Erectile Function-Erectile Function (IIEF-EF) and the effect of LiST on erectile function, as well as on safety, were the study outcomes. At 3 months, MCID was attained by 27 (79%) patients in the LiST group compared to 0 patients in the sham group. The risk difference between the 2 groups was 79% (95% confidence interval [CI]: 66-93, p <0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 4.4 points (95% CI: 3.4-5.4, p <0.001). At 1 month, MCID was attained by 20 (59%) patients in the LiST group compared to 1 (2.9%) patient in the sham group. The risk difference between the 2 groups was 56% (95% CI: 38-73, p <0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 3.9 points (95% CI: 2.7-5.2, p <0.001). Twelve sessions of LiST twice weekly for 6 weeks with a treatment protocol of 5,000 impulses, 0.096 mJ/mm2 energy flux density and 5 Hz frequency are highly effective in patients with moderate erectile dysfunction. Still, further long-term randomized studies are warranted to corroborate our findings.

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.

Molecular Effects of Low-Intensity Shock Wave Therapy on L6 Dorsal Root Ganglion/Spinal Cord and Blood Oxygenation Level-Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Changes in Capsaicin-Induced Prostatitis Rat Models.

Neurogenic inflammation and central sensitization play a role in chronic prostatitis/chronic pelvic pain syndrome. We explore the molecular effects of low-intensity shock wave therapy (Li-ESWT) on central sensitization in a capsaicin-induced prostatitis rat model. Male Sprague–Dawley rats underwent intraprostatic capsaicin (10 mM, 0.1 cm3) injections. After injection, the prostate received Li-ESWT twice, one day apart. The L6 dorsal root ganglion (DRG)/spinal cord was harvested for histology and Western blotting on days 3 and 7. The brain blood oxygenation level-dependent (BOLD) functional images were evaluated using 9.4 T fMRI before the Li-ESWT and one day after. Intraprostatic capsaicin injection induced increased NGF-, BDNF-, and COX-2-positive neurons in the L6 DRG and increased COX-2, NGF, BDNF, receptor Trk-A, and TRPV1 protein expression in the L6 DRG and the dorsal horn of the L6 spinal cord, whose effects were significantly downregulated after Li-ESWT on the prostate. Intraprostatic capsaicin injection increased activity of BOLD fMRI responses in brain regions associated with pain-related responses, such as the caudate putamen, periaqueductal gray, and thalamus, whose BOLD signals were reduced after Li-ESWT. These findings suggest a potential mechanism of Li-ESWT on modulation of peripheral and central sensitization for treating CP/CPPS.

Comparison of the efficacy of the early LI-SWT plus daily tadalafil with daily tadalafil only as penile rehabilitation for postprostatectomy erectile dysfunction

This study compares the efficacy of the early low-intensity shock wave therapy (LI-SWT) plus daily tadalafil with daily tadalafil only therapy as penile rehabilitation for postprostatectomy erectile dysfunction in patients with prostate cancer who underwent bilateral interfascial nerve-sparing radical prostatectomy (robotic or open). From April 2019 to March 2021, 165 patients were enrolled, and 80 of them successfully completed this prospective study. Daily tadalafil were administered to all the patients. LI-SWT consisted of a total of six sessions. Each session was performed on days 4, 5, 6, and 7, and on the second and fourth weeks after surgery. Each LI-SWT session consisted of 300 shocks at an energy density of 0.09 mJ/mm2 and a frequency of 120 shocks per minute that were delivered at each of the five treatment points for 15 min. Thirty-nine patients were treated with tadalafil-only (group A) while 41 were treated with tadalafil and LI-SWT simultaneously (group B). At postoperative 6 months, the proportion of patients with erection hardness scores (EHS) ≥ 3 (4/39 vs. 12/41) was significantly higher in group B (p = 0.034), and LI-SWT was the only independent factor for predicting EHS ≥ 3 (OR, 3.621; 95% CI, 1.054–12.437; p = 0.041). There were no serious side effects related to early LI-SWT. Early LI-SWT plus daily tadalafil therapy as penile rehabilitation for postprostatectomy erectile dysfunction is thought to be more efficacious than tadalafil only. Further large-scaled randomized controlled trials will be needed to validate these findings.

A0444 - Efficacy of low-intensity shock wave therapy on persistent storage symptoms after transurethral surgery for benign prostatic obstruction: Preliminary results of a randomized controlled trial

A0444 - Efficacy of low-intensity shock wave therapy on persistent storage symptoms after transurethral surgery for benign prostatic obstruction: Preliminary results of a randomized controlled trial