Microenergy shockwave therapies for female stress urinary incontinence.

Stress urinary incontinence (SUI) is one of the pelvic floor disorders affecting tens of million of women worldwide. In general, non-surgical options have relatively limited efficacy. The most effective treatment is mid-urethral sling surgery which carries substantial risks of perioperative and postoperative complications. Regenerative therapy with the injection of several types of stem cells and stem cell products is promising but further investigation is needed before clinical implementation can be considered. In recent years, the application of microenergy therapy as a non-invasive treatment for SUI has received increasing attention. Preclinical animal studies of these models have demonstrated that low-intensity extracorporeal shockwave therapy (Li-ESWT) and microenergy acoustic pulse (MAP) therapy are capable of regenerating urethral sphincter tissue and pelvic floor muscles leading to improved urinary continence. One pilot clinical trial with Li-ESWT also reported improved quality of life in women with SUI as well as the symptoms. The objective of this review is to summarize the potential mechanisms associated with Li-ESWT and MAP therapies of SUI: (I) activation of tissue-resident stem cells; (II) regeneration of musculature in the urethra and pelvic floor; (III) improvement in biomechanical property of pelvic floor muscles; (IV) modulation of cellular signaling pathways. Further studies of the molecular mechanisms, optimal treatment dosage and schedule, and potential long-term side effects are needed to provide this non-invasive regenerative therapy for millions of women with SUI.

The role of gut microbiota involved in prostate microenvironment and symptoms improvement in chronic prostatitis/chronic pelvic pain syndrome patients treated with low-intensity extracorporeal shock wave.

BACKGROUND: Low-intensity extracorporeal shockwave therapy (Li-ESWT) is emerging as a promising and safe treatment for Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). In this study, we aimed to investigate the role of the gut microbiota involved in the prostate microenvironment and symptom improvement during the Li-ESWT for CP/CPPS patients. METHODS: CP/CPPS patients not taking antibiotics or other treatments were included. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI), International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF-5) were used to evaluate the effectiveness of Li-ESWT at the end of treatment. Visual analogue scale/score was used to evaluate the pain during procedure. Stool and semen samples were collected before and after Li-ESWT. Shotgun metagenomics analyzed gut microbiota, while ELISA and other diagnostic kits detected biochemical changes in seminal plasma. RESULT: Of the 60 enrolled patients, 52 completed treatment. Li-ESWT response rate was 78.8% (41/52) at end of treatment. Among responders, the subitems of the NIH-CPSI; IPSS; and IIEF-5 scores improved significantly, and the seminal plasma analysis showed decreased TNF-a and MDA levels and increased SOD and Zn2+ levels posttreatment. Gut microbiome analysis indicated that posttreatment, both α and ß diversity increased, and the abundance of certain specific species significantly increased. Fifty-eight pathways significantly enriched posttreatment, notably in branched-chain amino acid synthesis and butyrate synthesis. The abundance of several specific species was found to be significantly higher in non-responders than responders. Among responders, at the species level, some bacteria associated with NIH-CPSI and its subscales, IPSS, IIEF-5, and prostate microenvironment markers (TNF-a, MDA, Zn2+, and SOD) were identified. CONCLUSIONS: Our study demonstrates for the first time that Li-ESWT improves the prostate microenvironment and gut microbiota in CP/CPPS patients. Treatment nonresponse may be associated with a high abundance of specific pathogens before treatment. The gut microbiota could have a significant impact on Li-ESWT response and the prostate microenvironment.

Effects of low-intensity extracorporeal shock wave therapy on lipopolysaccharide cystitis in a rat model of interstitial cystitis/bladder pain syndrome.

PURPOSE: To investigate the effect of low-intensity extracorporeal shock wave therapy (LiESWT) on lipopolysaccharide (LPS)-induced cystitis in an animal model of interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: Sprague-Dawley rats were divided into three groups: control, cystitis (LPS group, intravesical injection of LPS (1 mg) twice), and cystitis with LiESWT (LiESWT group). On the third and fourth days, LiESWT was administered (0.12 mJ/mm2, 300 shots each time) on the lower abdomen toward the bladder. On the seventh day, the rats underwent pain assessment and a metabolic cage study. Subsequently, a continuous cystometrogram (CMG) was performed under urethane anaesthesia. Immunohistochemical studies were also performed, including S-100 staining, an immunohistochemical marker of Schwann cells in the bladder. RESULTS: In the LPS group, the pain threshold in the lower abdomen was significantly lower than that in the control group. In the metabolic cage study, the mean voided volume in the LPS group significantly increased. The CMG also revealed a significant decrease in bladder contraction amplitude, compatible with detrusor underactivity in the LPS group. Immunohistochemical studies showed inflammatory changes in the submucosa, increased fibrosis, and decreased S-100 stain-positive areas in the muscle layer of the LPS group. In the LiESWT group, tactile allodynia and bladder function were ameliorated, and S-100 stain-positive areas were increased. CONCLUSION: By restoring nerve damage, LiESWT improved lower abdominal pain sensitivity and bladder function in an LPS-induced cystitis rat model. This study suggests that LiESWT may be a new therapeutic modality for IC/BPS.

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

PURPOSE: 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 5 mg tadalafil daily versus LI-SWT plus 20 mg tadalafil alternate-day in PDE5i -resistant ED. MATERiALS 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 5 mg tadalafil daily), and C (LI-SWT plus 20 mg 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. RESULTS: 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 6 months 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. CONCLUSiON: 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.

Efficacy Analysis of Physical Therapy in Treating Chronic Prostatitis: Unblocking Obstructed Glandular Ducts Could Be a Novel Treatment Strategy.

Objective: This study investigates the efficacy of physical therapy in treating chronic prostatitis grounded on the glandular duct blockage theory. Methods: The study includes patients who were diagnosed and treated for chronic prostatitis between November 2022 and July 2023 at Renhui clinic in Jiangmen, Guangdong and Renhui frontline clinic in Shenzhen Guangdong. The recorded data includes the frequency of physical therapies including prostate massages, rectal probe high-frequency vibration treatment, and low-intensity extracorporeal shockwave therapy (Li-ESWT). Post-treatment urine sediment was collected for microscopic examination, and the scores of each patient on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and the Premature Ejaculation Diagnostic Tool (PEDT) were recorded pre- and post-treatment in order to calculate the effectiveness rate. Results: The study involved a total of 48 patients, of which 26 were diagnosed with premature ejaculation. On average, each patient received 2.1 prostate massages, underwent 4.1 rectal probe high-frequency vibration treatments, and 8.3 Li-ESWT sessions. Following treatment, the initial microscopic examination of the urine sediment revealed aged white blood cell clusters, prostate calculi clusters, and inactive sperm clusters, all appearing in the shape of glandular tubes. The mean NIH-CPSI scores pre- and post-treatment were 27.2±6.9 and 18.0±6.6, respectively, indicating an effectiveness rate of 81.3%. The average PEDT scores pre- and post-treatment were 14.5±3.5 and 10.5±4.2, respectively, with an effectiveness rate of 53.8%. Conclusion: Unblocking obstructed glandular ducts might provide a novel therapeutic strategy for treating chronic prostatitis.

Efficacy of Low-Intensity Extra Corporal Shockwave Therapy (LI-ESWT) in Patients With Erectile Dysfunction.

Objective: Erectile dysfunction (ED) is a common cause of sexual disorders in men with limited treatment options. This study aimed to determine the efficacy of low-intensity extra corporal shockwave therapy (LI-ESWT) in patients suffering from ED. Materials and methods: A single-group, pre-test, and post-test pre-experimental study were conducted. Thirty-one ED patients were prospectively selected according to the eligibility criteria. In each session, 3000 shocks were applied at 5 points over the penis. Eight sessions were delivered in total with a 2-3-day interval. The patient's condition was assessed using the International Index of Electric Function (IIEF-5) questionnaire at baseline and one month after the last treatment session. Paired t-test was used to determine the difference between the pre-test and post-test. Results: Mean age of the patients was 44.6 (± 14.70) ranging from 25 to 78 years. The majority of them were married (83.9%) and service providers (51.6%). We have also found 51.6% overweight, 9.7% obese, 48.4% diabetic, 45.2% hypertensive, 12.9% with enlarged prostate, 45.2% smoker, 25.8% alcoholic, and 71% with sleep disturbances. During the pre-test, 9.7% had severe ED and 51.6% had moderate ED. After the treatment, no patients were found with severe ED, and few of them had moderate ED (9.7%). The mean difference in IIEF-5 score during the pre-test and post-test was statistically significant (p= < 0.001). Conclusion: The study showed efficacy of LI-ESWT in a subset of patients with ED. Future studies with larger sample size, placebo group, and longer follow-up periods are recommended.

Low-intensity extracorporeal shockwave therapy for diabetic men with erectile dysfunction: A systematic scoping review.

BACKGROUND: Erectile dysfunction (ED) is a very common complication in men with diabetes mellitus (DM). Low-intensity extracorporeal shockwave therapy (Li-ESWT) offers a promising nonsurgical treatment option for ED. A systematic scoping review investigating the outcomes of Li-ESWT in diabetic men with ED has not yet been performed. OBJECTIVES: To systematically review animal and clinical studies related to the use of Li-ESWT for treatment of DM-related ED. DATA SOURCES: PubMed, Embase, The Cochrane Library, Scopus, and Web of Science were searched, unrestricted by dates or study design. MATERIALS AND METHODS: We included qualitative studies, quantitative studies, primary research studies, meta-analyses, and research letters written in English. Full text reviewing was completed in all animal and human studies discussing Li-ESWT for the treatment of ED in subjects with DM. Data extracted included the journal citation, publication year, country of origin, study design, and a summary of the pertinent findings. RESULTS: Our search yielded nine clinical studies and 10 animal studies. The results of the clinical studies suggest that Li-ESWT is a safe and effective treatment in men with well-controlled DM and moderate or better ED. However, the benefit is less durable in diabetic men than nondiabetic men. The results of the animal studies suggest that Li-ESWT can significantly improve erectile function in diabetic rat models with ED. CONCLUSIONS: The examined studies present encouraging results for the use of Li-ESWT to treat diabetic men with ED. Future studies, particularly robust randomized controlled trials, are necessary to confirm these findings and provide long-term follow-up.

The management of erectile dysfunction in men with diabetes mellitus unresponsive to phosphodiesterase type 5 inhibitors.

INTRODUCTION: Erectile dysfunction is associated with diabetes mellitus with an estimated prevalence of 52.5% in the diabetic population. The first-line therapy for erectile dysfunction is phosphodiesterase type 5 inhibitors, but data suggest that diabetic men may be less responsive than non-diabetic men. Thus, other treatments, including intracavernosal injections, intraurethral prostaglandin, vacuum erection devices and penile prosthetic surgery, should be considered in management of diabetic men with erectile dysfunction refractory to phosphodiesterase type 5 inhibitors. Furthermore, combination therapy of phosphodiesterase type 5 inhibitors and other oral treatments such as arginine or l-carnitine may have synergistic effects resulting in better outcomes. In addition, there are novel therapies such as low-intensity shockwave therapy and stem-cell therapy, which may also be effective in targeted treatment modalities. Furthermore, studies suggest that erectile dysfunction can be improved by targeting concurrent comorbidities or metabolic diseases such as depression, hypertension, hypogonadism, and dyslipidaemia. We present an evidence-based narrative review focusing on the management of erectile dysfunction in diabetic men who have not responded to phosphodiesterase type 5 inhibitors. CONCLUSIONS: Both clinicians and patients should be aware of the different management options in diabetic patients who have not responded to phosphodiesterase type 5 inhibitors.

[Low-intensity extracorporeal shockwave therapy improves symptoms of erectile dysfunction: A preliminary study].

OBJECTIVE: To verify the effect and safety of low-intensity extracorporeal shockwave therapy (Li-ESWT) in improving the symptoms of ED, and provide some reference for further related large-scale clinical trials. METHODS: Twenty-six patients diagnosed with ED received Li-ESWT with an energy of 0.09 mJ/mm2 for 20 minutes once a week for 6 four-week courses. Before and at 3, 6, 9, and 12 months after treatment, we obtained the IIEF-5 and Erectile Hardness Scale (EHS) scores of the patients using questionnaires, recorded the incidence of treatment-related adverse reactions, compared the erectile function of the patients before and after treatment, and evaluated the effect and safety of Li-ESWT in improving ED-related symptoms. RESULTS: Compared with the baseline, the IIEF-5 scores of the patients were significantly increased (P < 0.01) while the EHS scores slightly increased at 3 months after Li-ESWT treatment (P > 0.05), both IIEF-5 and EHS scores were dramatically increased at 6 months (P < 0.01), and both significantly higher than at 3 months. At 9 months, EHS scores remained remarkably higher than the baseline (P < 0.01) although IIEF-5 scores slightly lower than at 6 months. At 12 months, however, IIEF-5 scores decreased, though still significantly higher than the baseline (P < 0.01), and EHS scores became lower than at 6 and 9 months (P < 0.05) but still markedly higher than before treatment (P < 0.05). Adverse reactions observed during the intervention mainly included pruritus (4.35%), pain (2.90%), paresthesia (2.17%), and petechiae/ecchymosis (2.90%). CONCLUSION: Li-ESWT can increase the IIEF-5 and EHS scores and improve the clinical symptoms of ED patients, with a low incidence of adverse reactions during the treatment.

Low-intensity Extracorporeal Shockwave Therapy for the Management of Postprostatectomy Erectile Dysfunction: A Systematic Review of the Literature.

Context: Erectile dysfunction (ED) following radical prostatectomy is a concern for patients and their partners. Low-intensity extracorporeal shockwave therapy (LI-ESWT) can potentially enhance tissue repair and regeneration. The aim of the current study was to systematically review the literature to assess the role of LI-ESWT in the management of patients with postprostatectomy ED. Evidence acquisition: Two authors independently performed a systematic search of the PubMed and Web of Science databases to identify all relevant articles. Non-English reports, case reports, reviews, letters, and editorials were excluded. Risk of bias was assessed according to the GRADE guidelines. Evidence synthesis: Nine articles met the inclusion criteria and were included in the qualitative analysis. All the studies included were published between 2015 and 2022 and the majority of them compared phosphodiesterase type 5 inhibitors (PDE5Is) alone versus a combination of LI-ESWT and PDE5Is. Only three studies were randomized controlled trials (RCTs). In general, there is no standardized protocol for LI-ESWT for postprostatectomy ED. In comparisons of LI-ESWT + PDE5Is versus PDE5Is alone, some authors found a statistically significant improvement in erectile function with LI-ESWT + PDE5Is. The starting time for LI-ESWT differed among the studies, ranging from 3 d to 6 mo after surgery. The main limitations of the review are the scarcity of studies, small sample sizes, high risk of bias, and high heterogeneity among studies. Conclusions: There is currently limited evidence on the use of LI-ESWT either alone or in combination with PDE5Is in penile rehabilitation protocols after prostatectomy. However, small clinical trials with short follow-up show that LI-ESWT could potentially play a role in the management of postprostatectomy ED in the future. Further RCTs with larger sample sizes are needed. Patient summary: Despite limited reports in the literature, low-intensity shockwave therapy after removal of the prostate is a promising noninvasive treatment for dealing with erectile dysfunction after surgery.

Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial.

INTRODUCTION: Radial wave therapy is commercialized as an option for the management of erectile dysfunction. However, the mechanism of action of the radial waves differs substantially from shock waves, so the evidence gathered for shock wave therapy cannot be extrapolated, and there are very few clinical trials with the radial wave. AIM: To assess the efficacy and safety of radial wave therapy compared with sham therapy for the treatment of moderate and mild to moderate erectile dysfunction. METHODS: A randomized, double-blind, sham-controlled clinical trial was realized. Eighty patients with moderate erectile dysfunction, without sickle cell anemia, anticoagulation treatment, comorbidities, or conditions associated with secondary erectile dysfunction were included. The efficacy and safety were assessed at 6 and 10 weeks after randomization. Patients were randomized 1:1 to 1 of 2 arms: (i) 6 weekly sessions of radial wave therapy (RW group) or (ii) 6 weekly sessions of sham therapy (control group). All patients received sildenafil 25 mg. OUTCOME: The primary outcome was the mean change in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 weeks after randomization. RESULTS: Eighty men were randomized. The average baseline IIEF-EF score was 16.3 (Standard Deviation - SD 3.2), and the median baseline Erection Hardness Score (EHS) was 3 (IQR 1). At 6 weeks after randomization, the mean change in the IIEF-EF score was 3.4 (95% confidence interval [CI] 1.5-5.2) in the RW group and 4.2 (95% CI 2.5-5.9) in the control group. No differences were observed between groups (P value =.742). No change was observed in the median EHS score in the evaluations. No serious adverse events occurred in 2 (5%) patients after radial wave therapy, and in 1 (2.5%) patient after sham therapy. CLINICAL IMPLICATIONS: Knowledge of the effectiveness of radial waves protocols used for the treatment of moderate erectile dysfunction, helps doctors and patients in making decisions about the use of this therapy. STRENGTHS & LIMITATIONS: One strength is conducting the study with high methodological standards to minimize risk biases. Our results are limited to the evaluation of 1 specific protocol in moderate and mild to moderate erectile dysfunction. CONCLUSIONS: No difference was found in this study between men with moderate and mild to moderate erectile dysfunction treated with radial waves and men treated with placebo sham therapy. Studies with different protocols of radial waves are necessary. Sandoval-Salinas C, Saffon JP, Martínez JM, et al. Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial. J Sex Med 2022;19:738-744.

Systematic Review and Meta-Analysis of 16 Randomized Controlled Trials of Clinical Outcomes of Low-Intensity Extracorporeal Shock Wave Therapy in Treating Erectile Dysfunction.

We conducted a meta-analysis to evaluate the efficacy of low-intensity extracorporeal shock wave therapy (LI-ESWT) in the treatment of erectile dysfunction (ED). From July 2011 to June 2021, we finally selected 16 randomized controlled trials (RCTs) including 1,064 participants to evaluate the efficacy of LI-ESWT in the treatment of ED from PubMed, EMBASE, and Cochrane databases. The data are analyzed by Review Manager Version 5.4. Fifteen articles mentioned International Index of Erectile Function (IIEF), in the follow-up of 1 month (mean difference [MD] = 3.18, 95% confidence interval [CI] = [1.38, 4.98], p = .0005), 3 months (MD = 3.01, 95% CI = [2.04, 3.98], p < .00001), and 6 months (MD = 3.20, 95% CI = [2.49, 3.92], p < .00001). After treatment, the improvement of IIEF in the LI-ESWT group was better than that in the control group. Besides, eight of the 16 trials provided data on the proportion of patients with baseline Erectile Hardness Score (EHS) ≤ 2 improved to EHS ≥ 3. The LI-ESWT group was also significantly better than the placebo group (odds ratio [OR] = 5.07, 95% CI = [1.78, 14.44], p = .002). The positive response rate of Questions 2 and 3 of the Sexual Encounter Profile (SEP) was not statistically significant (SEP2: OR = 1.27, 95% CI = [0.70, 2.30], p = .43; SEP3: OR = 4.24, 95% CI = [0.67, 26.83], p = .13). The results of this meta-analysis suggest that treatment plans with an energy density of 0.09 mJ/mm2 and pulses number of 1,500 to 2,000 are more beneficial to IIEF in ED patients. In addition, IIEF improvement was more pronounced in patients with moderate ED after extracorporeal shockwave therapy.

Technological Advancements for Treating Erectile Dysfunction and Peyronie's Disease.

Over the past decade, there have been several advancements in the technologies available to treatment erectile dysfunction and Peyronie's disease. Vacuum erection devices, penile traction devices, low-intensity extracorporeal shockwave therapy, and penile prosthesis surgery have evolved and are changing the way we treat men's health. Although significant improvements have been made, further work is needed to standardize treatment, create universal algorithms for technological applications, and simply their use.

Low-intensity extracorporeal shockwave therapy for erectile dysfunction: an overview of systematic reviews.

BACKGROUND: Low-intensity extracorporeal shockwave therapy (LI-ESWT) may be a successful complementary treatment approach for erectile dysfunction (ED). In this study, we aimed to review and summarize the research evidence from systematic reviews (SRs)/meta-analyses (MAs) regarding the clinical effectiveness of LI-ESWT for ED. METHODS: Studies on LI-ESWT for ED were searched using eight electronic databases from establishment of each database to 31 June 2021 with the language restrictions of Chinese and English. All articles were screened, and qualifying data were recorded based on the inclusion criteria. Methods including: the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2); the Risk of Bias in Systematic Reviews (ROBIS); the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA); and Grading of Recommendations, Assessment Development, and the Evaluation (GRADE) were used by two independent raters to assess methodological quality, risk of bias, reporting quality, and SR evidence of quality, respectively. RESULTS: Eight SRs/MAs met all inclusion criteria. Seven reviews were rated as critically low on overall confidence and one review was low on confidence based on the AMSTAR-2 appraisal tool. While most PRISMA criteria were met, the major reporting flaws were in relation the financial statements not being included, along with no protocol registrations. Three SRs/MAs were classed as low risk regarding bias as measured by the ROBIS tool. Based on the GRADE method, only one SRs/MAs of high-quality evidence and seven SRs/MAs of moderate-quality evidence were found. The present research results supported LI-ESWT as a complementary therapy for ED patients, but the evidence should be considered carefully due to the methodological flaws identified. DISCUSSION: Our results showed that LI-ESWT as an adjunctive therapy has benefits for ED patients. There were no obvious side effects, and the number of shockwave treatments and energy flux density (EFD) would affect the IIEF-EF, EHS and PSV scores. However, due to the limited sample size and the quality of reporting evidence, our conclusions may not be fully representative.

Low-intensity extracorporeal shockwave therapy for erectile dysfunction.

Objectives: To review the current evidence of clinical effectiveness of low-intensity extracorporeal shockwave therapy (LI-ESWT) treatment for erectile dysfunction (ED). METHODS: A selective database search using Medical Subject Headings (MeSH) terms 'low intensity extracorporeal shock wave therapy' and 'erectile dysfunction' was conducted in accordance with the Preferred Reporting Items for Systemic Reviews and Meta Analyses (PRISMA) guidelines to review the effectiveness of LI-ESWT for ED. We performed a systematic search of publications using the PubMed and Web of Science databases (January 2010-December 2020) for prospective randomised clinical trials (RCTs). The success rate of LI-ESWT associated with ED were recorded and analysed. RESULTS: A total of 106 articles were reviewed after searching for the keywords. Overall, 11 RCTs were included in this systematic review. A total of 920 male patients were treated in 11 RCTs. The patients' ages ranged from 18 to 80 years and they had ≥3 months of ED symptoms. Vasculogenic and neurogenic causes were addressed in 81% and 19% of patients, respectively. Of the 920 patients, 348 patients had a statistically significant improvement in their erectile function after LI-ESWT; however, 572 did not have a statistically significant improvement. CONCLUSIONS: The present review found that LI-ESWT has a role in ED treatment in laboratory studies, but its role in human clinical trials is still controversial. Further good quality studies need to be conducted to properly assess its true potential in ED treatment.

Are Radial Pressure Waves Effective in Treating Erectile Dysfunction? A Systematic Review of Preclinical and Clinical Studies.

INTRODUCTION: Radial waves are used to treat erectile dysfunction; however, they are different than focal waves, and their mechanism of action or effect on improving this condition is not known. AIM: To evaluate the effect of radial waves at the cellular level and their effectiveness at the clinical level for the treatment of erectile dysfunction. METHODS: Systematic literature review. Electronic database searches and manual searches were performed to identify (i) clinical trials or cohort studies evaluating the effectiveness of radial waves in men with erectile dysfunction and (ii) preclinical trials in animal models or cell cultures in which the production of nitric oxide or endothelial growth factor was evaluated. Study quality was assessed, and data were extracted from each study. A narrative synthesis of the results was performed given the high heterogeneity between the selected studies. MAIN OUTCOMES MEASURES: Nitric oxide production, endothelial growth factor expression, and changes in the Erection Hardness Score (EHS) and the International Index of Erectile Function (IIEF) Questionnaire score. RESULTS: Four studies in animal models and 1 randomized clinical trial in men with erectile dysfunction and kidney transplantation were identified that met the selection criteria. Preclinical studies in animals suggest that radial waves increase cellular apoptosis in penile tissue, while vascular endothelial growth factor expression increases in brain tissue. In men with erectile dysfunction, no differences were found between radial wave therapy and placebo therapy in the mean IIEF score (15.6 ± 6.1 vs 16.6 ± 5.4 at 1 month after treatment), EHS (2.5 ± 0.85 vs 2.4 ± 0.7 at 1 month after treatment), or penile Doppler parameters. CONCLUSIONS: No quality evidence was found to support the use of radial waves in humans for the treatment of erectile dysfunction. In animal models and at the cellular level, the results are contradictory. More research is needed. Sandoval-Salinas C, Saffon JP, Corredor HA, et al. Are Radial Pressure Waves Effective in Treating Erectile Dysfunction? A Systematic Review of Preclinical and Clinical Studies. Sex Med 2021;9:100393.

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

PURPOSE: 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. METHODS: 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 4 weeks, 5000 shocks/session, 0.09 mJ/mm2 energy density) and 36 were treated with a sham probe. Baseline and post-treatment (1, 3 and 6 months) 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. RESULTS: 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. CONCLUSION: 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.

Combined treatment with extracorporeal shockwaves therapy and an herbal formulation for activation of penile progenitor cells and antioxidant activity in diabetic erectile dysfunction.

BACKGROUND: A Korean herbal formulation named KH-204 was reported to have an antioxidant effect in our previous study. We hypothesized that Low-intensity extracorporeal shockwave therapy (Li-ESWT) combined with KH-204 would accelerate the treatment of erectile dysfunction (ED) by enhancing antioxidant. We investigated the synergistic effect of Li-ESWT and KH-204 for ED and explored the mechanism. METHODS: Human umbilical vein endothelial cells (HUVEC) were treated with KH-204 and LI-ESWT in vitro. Fifty 5-week-old male Sprague Dawley rats received an intraperitoneal injection of 5-ethynyl-20-deoxyuridine (EdU) which can label live cells, and were randomly divided into five groups: (I) normal; (II) diabetes mellitus-associated erectile dysfunction (DMED); (III) DMED + KH-204; (IV) DMED + Li-ESWT; and (V) DMED + KH-204/Li-ESWT. Li-ESWT treatment was repeated three times a week every other day for four weeks in group 4 and 5. Meanwhile, rats in group 3 and 5 were orally fed 400 mg/kg of KH-204 daily for 1 month. Following a 1-week washout period, penile tissues were evaluated by immunostaining and Western blotting. RESULTS: KH-204 combined with Li-ESWT improved intracavernosal pressure (ICP) in DMED rats. Li-ESWT/KH-204 stimulated HUVEC tube formation and promoted proliferation. Li-ESWT drove progenitor cells to migrate to penile tissue and KH-204 protected penile progenitor cells in the corpus cavernosum. Oxidative stress was relieved by KH-204/Li-ESWT. Treatment with KH-204/Li-ESWT protected penile progenitor cells, which were recruited to the corpus cavernosum by Li-ESWT, from apoptosis via its antioxidant activity. KH-204/Li-ESWT protected penile tissue from oxidative stress by improving the expression of nuclear factor erythroid 2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1), increasing superoxide dismutase (SOD), decreasing 8-hydroxy-20-deoxyguanosine (8-OHdG), and reducing apoptosis. KH-204/Li-ESWT promoted stromal derived factor-1 (SDF-1) and platelet endothelial cell adhesion molecule-1 (PECAM-1) in DMED rats. CONCLUSIONS: KH-204 protected penile progenitor cells, which were recruited to the corpus cavernosum by Li-ESWT, from apoptosis via its antioxidant activity. The combination of Li-ESWT and KH-204 as a synergy therapy could be a potential and effective treatment for DMED.

Low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction after penile trauma.

In urology low-intensity extracorporeal shockwave therapy (LI-ESWT) finds major application in the treatment of erectile dysfunction (ED) after nerve-sparing radical retropubic prostatectomy and Peyronie's disease. We presented a rare case of application of LI-ESWT in a 39-years old man with erectile dysfunction after penile trauma obtained during sexual intercourse.

The Basic Physics of Waves, Soundwaves, and Shockwaves for Erectile Dysfunction.

INTRODUCTION: Over the past decade, low-intensity extracorporeal shockwave therapy (Li-ESWT) has emerged as a treatment modality for erectile dysfunction (ED). To better appreciate the differences between the various devices for the treatment of ED, it is imperative for physicians to understand the underlying physics of the different shockwave generators. AIM: In this article, we explain the physics of shockwaves by establishing a foundation regarding the basics of waves, specifically soundwaves. We also describe the different shockwave generators available and assess their potential clinical utility. METHODS: We reviewed basic principles of wave propagation, randomized controlled trials investigating Li-ESWT for ED and other medical diseases, and individual industry shockwave generator websites, in order to describe the basic physics underlying Li-ESWT. MAIN OUTCOME MEASURE: We primarily aimed to describe the physics underlying shockwave generators and to provide a framework for understanding the relevant subtypes and adjustable parameters. RESULTS: A wave is a disturbance in a medium that transports energy without permanently transporting matter. In shockwaves, a soundwave is generated with a speed faster than the local speed of sound. Shockwaves are classically generated by three different types of energy sources: electrohydraulic, electromagnetic, or piezoelectric, which all create a shockwave through the conversion of electric potential energy to mechanical energy. Importantly, radial pressure waves do not behave the same as conventional shockwaves and are more like "ordinary" sound waves in that they achieve a significantly lower peak pressure, a slower rise time, and propagate outwards without a focal point. CLINICAL IMPLICATIONS: Li-ESWT is not currently approved by the U.S. Food and Drug Administration and is considered investigational in the United States. However, it is currently available to patients under clinical trial protocols and it is important to understand the basic physics of shockwaves to understand the differences between the different shockwave devices. STRENGTH & LIMITATIONS: This is a comprehensive review of the physics underlying Li-ESWT but only tangentially explores the biological impact of shockwaves. CONCLUSION: Physicians currently using or those contemplating purchasing a Li-ESWT device should understand the basic physics underlying the device, as well as which treatment protocols were used to demonstrate clinical efficacy in treating ED. Katz JE, Clavijo RI, Rizk P, et al. The Basic Physics of Waves, Soundwaves, and Shockwaves for Erectile Dysfunction. Sex Med Rev 2020;8:100-105.