Safety Of Low-intensity Shockwave Therapy Research Articles

(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= <0.05); I2 = 74%, the overall effect is Z= 3.35, p = <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

Low-intensity shockwave therapy for the management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and meta-analysis.

To perform a systematic review and meta-analysis aiming to improve the level of evidence and determine the efficacy and safety of low-intensity shockwave therapy (LiST) in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We searched PubMed, Cochrane Library and Scopus databases from inception to November 2020 for randomised controlled trials (RCTs) exploring the role of LiST for the management of CP/CPPS. We performed a random-effects meta-analysis of RCTs comparing LiST vs sham therapy on CP/CPPS symptoms at different time-points after treatment. Weighted mean differences (WMDs) with the corresponding confidence intervals (CIs) were estimated. Furthermore, we assessed the strength of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system (International Prospective Register of Systematic Reviews [PROSPERO]: CRD42020208813). We included five sham RCTs and one non-sham RCT. In the meta-analysis of sham RCTs, both the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) pain domain score and the numeric pain rating scale improved significantly after LiST vs sham therapy at the assessment directly after treatment protocol completion (WMD 3.2, 95% CI 0.88-5.52, I2 = 90%; and WMD 1.43, 95% CI 0.85-2.01, I2 = 32%, respectively), at 1month (WMD 4.4, 95% CI 2.84-5.95, I2 = 68%, and WMD 2.59, 95% CI 1.92-3.27, I2 = 83%, respectively), and at 3months after last treatment session (WMD 3.61, 95% CI 1.49-5.74, I2 = 90%, and WMD 2.64, 95% CI 2.13-3.16, I2 = 71%, respectively). Similarly, the NIH-CPSI total and quality-of-life domain scores improved significantly after LiST compared to sham therapy for the same time-points. Conversely, the long-term efficacy of LiST, as well as the effect of LiST on lower urinary tract symptoms and erectile function, was clinically insignificant. LiST is an effective treatment modality for the improvement of pain and quality of life in patients with CP/CPPS. Therefore, it should be recommended as a part of individualised treatment strategies in such patients.

Evaluation of a low-intensity shockwave therapy for chronic prostatitis type IIIb/chronic pelvic pain syndrome: a double-blind randomized sham-controlled clinical trial.

Currently, there is no efficacious treatment method for chronic prostatitis type IIIb/chronic pelvic pain syndrome (CP/CPPS). Aim of the study was to investigate and compare the efficacy and safety of low-intensity shockwave therapy (LiST) vs. sham treatment in CP/CPPS patients. Patients with CP/CPPS diagnosis were randomized in this prospective, sham-controlled, double-blind study either to the active groups (Group B, C) who received 5000 shockwaves per session with energy flux density 0.1 mJ/mm2 or to the sham group (Group A) who received 5000 shockwaves from a visually identical sham probe. All groups underwent six sessions (once/week). LiST effects on pain, micturition, quality of life (QoL), and erectile function were evaluated at 4, 12, and 24 weeks after treatment. The parameters were investigated using validated questionnaires. Uroflowmetry and post void residual calculation were performed at baseline and at 4- and 12-week FU visit. Prostate mpMRI and PSA measurement were performed at baseline and 12-week FU visit. Overall, 45 men were randomized to the active (n = 30) and sham groups (n = 15). Regarding impact of LiST in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total, pain, and QoL subdomains scores a clear and persistent in all FU timepoints improvement was found compared to sham treatment. NIH-CPSI urinary subdomain, International Prostate Symptom Score [IPSS], PSA, and mpMRI-PIRADS scores did not differ between the two groups. The mean difference between the LiST and sham group in the change of the NIH-CPSI pain-domain score (Q1-4) from baseline to 12 weeks after final treatment which was 3.3 (95% CI, 1.8, 4.7). Perineal LiST was easy and safe to perform without anesthesia or any side-effects. LiST seems to be a safe and effective treatment option for CP/CPPS, considerably improving pain and quality of life. Lack of any side-effects, and the potential for repetition make LiST a promising treatment choice for CP/CPPS patients.

Low-Intensity Shockwave Therapy (LiST) for Erectile Dysfunction: Is It Safe for Patients on Anticoagulant Medication?

IntroductionA significant percentage of men with vasculogenic erectile dysfunction (ED) use antiplatelet therapy because they have a history of cardiovascular disease. However, the safety of this novel treatment modality in patients under antiplatelet treatment has been based on anecdotal cases, and published data are lacking. The aim of this study is to examine the safety of low-intensity shockwave therapy (LiST) on a group of patients under antiplatelet therapy who were treated with LiST. MethodsA pulled data analysis, conducted from November–December 2018, including 2 randomized clinical trials conducted at an Andrology outpatient clinic is presented. The 2 trials used the same design, the same shockwaves generator, as well as the same method of delivering the energy. The LiST protocol differed between the patients regarding LiST sessions number (6, 12, or 18), sessions frequency (1, 2, or 3 sessions/wk) and energy flux density used, which was either 0.05 or 0.1 mJ/mm2. The number of 5,000 pulses/session remained unchanged. For the purpose of the current study, patients receiving anticoagulant medication at the time of treatment and follow-up period were included in this analysis. All patients had a diagnosis of vasculogenic ED. According to the study protocol, after every treatment visit, as well as at 1 and 3 months after treatment, all patients reported any side effects or complications of the treatment; physical examination of the penis was performed before and after each treatment session, as well as at follow-up visits at 1 and 3 months. Penile ultrasonography was performed at baseline, as well as at 3 months’ follow-up, at the same time with triplex ultrasonography by the same investigator. Results138 patients were included in the 2 trials, whereas 135 (98%) of them finished the 3 months follow-up. 35 (25.3%) of them were under anticoagulant/antiplatelet medication during LiST. No bleeding events or any other side effects were reported. Strengths & LimitationsThe main strength of this article is that it is the first report on the safety of LiST on the specific group of cardiovascular patients with ED under anticoagulant/antiplatelet therapy. However, it is a pulled data analysis, based on 2 randomized studies, which did not have safety of LiST as a primary outcome. ConclusionLiST seems to be a safe and well-tolerated treatment option for vasculogenic ED in patients on antiplatelet medication.Kalyvianakis D, Memmos D, Mykoniatis I, et al. Low-Intensity Shockwave Therapy (LiST) for Erectile Dysfunction: Is It Safe for Patients on Anticoagulant Medication? J Sex Med 2019;16:1478–1480.

50] The efficacy and safety of low-intensity shockwave therapy in erectile dysfunction

ObjectiveTo assess the effectiveness and safety of low-intensity extracorporeal shockwave therapy (Li-ESWT) on patients with erectile dysfunction (ED).

Twelve-Month Efficacy and Safety of Low-Intensity Shockwave Therapy for Erectile Dysfunction in Patients Who Do Not Respond to Phosphodiesterase Type 5 Inhibitors

IntroductionLow-intensity shockwave therapy (LISWT) has recently emerged as a promising method in the treatment of erectile dysfunction (ED).AimTo assess the long-term results of the effectiveness and safety of LISWT in patients with ED who are non-responders to phosphodiesterase type 5 inhibitor (PDE5i) treatment.MethodsThis open-label, longitudinal, and observational study investigated an uncontrolled population of 50 consecutive patients whose ED was unresponsive to PDE5i treatment. Patients were treated with a four-session LISWT protocol. During active treatment and follow-up, all patients remained on their regular high on-demand or once-daily PDE5i dosing schedules.Main Outcome MeasuresEffectiveness was assessed according to the International Index of Erectile Function erectile function domain, questions 2 and 3 of the Sexual Encounter Profile, Erection Hardness Scale, and Global Assessment Question scores at baseline and at 3, 6, 9, and 12 months after treatment. Patients were considered responders whenever they showed improvement in erection parameters in all four assessments and responded positively to the Global Assessment Question. Adverse events were recorded. Statistical variables were applied and findings were considered statistically significant at a P value less than < .05.ResultsEighty percent (mean age = 64.8 years) completed the 12-month follow-up. Positive response rates were 60% of available subjects at the end of the study and 48% of the intent-to-treat population. After the 12-month follow-up, 91.7% of responders maintained their responses. No patient reported treatment-related adverse events.ConclusionLISWT in patients with ED unresponsive to PDE5i treatment was effective and safe in 60% of patients treated. The efficacy response was maintained for 12 months in most patients.