Twelve-Month Efficacy and Safety of Low-Intensity Shockwave Therapy for Erectile Dysfunction in Patients Who Do Not Respond to Phosphodiesterase Type 5 Inhibitors (original) (raw)
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Arab Journal of Urology
Objective: To evaluate the long-term (18 months) effectiveness, safety, and factors that may predict the success of low-intensity shockwave lithotripsy (Li-SWT) in patients with erectile dysfunction (ED) who fail to respond to oral phosphodiesterase type 5 inhibitors (PDE5i). Patients and Methods: This prospective study included 52 patients with ED of vascular origin who failed to respond to oral PDE5i. The International Index of Erectile Function-Erectile Function domain (IIEF-EF) and Erection Hardness Score (EHS) questionnaires were used to evaluate EF. Patients under went two Li-SWT treatment sessions per week for 3 weeks, followed by a 3-week treatment-free period, and the cycle was repeated until each patient received 12 treatment sessions. Patients were followed-up after Li-SWT at 3, 6, 12, and 18 months. Results: At the 18-month follow-up, 33 patients (63.5%) were able to achieve an erection sufficient for penetration with or without PDE5i (22 were maintained on oral PDE5i). The remaining 19 patients (36.5%) had a poor response to Li-SWT and oral PDE5i. The initial response showed some decline in 50% of the initial responders. Younger men (aged <45 years), short ED duration (<2 years), and moderate ED severity responded better to Li-SWT. There were no adverse side-effects. Conclusion: In the present study, Li-SWT was a safe and effective treatment in 63.5% of men with ED who failed to respond to oral PDE5i. Factors such as age (<45 years), ED duration (<2 years), and ED severity can predict treatment outcome in such patients.
European Urology Focus
Low-intensity extracorporeal shockwave therapy (LI-ESWT) aims to reverse the underlying aberrant mechanisms that lead to the development of erectile dysfunction (ED) and is unlike other commonly used treatment options such as intracavernosal injection (ICI) and phosphodiesterase type 5 inhibitor (PDE-5i) agents. Therefore, there is substantial interest in this novel treatment modality. In this Clinical Consultation Guide we discuss the evidence for LI-ESWT as first-line therapy for PDE-5i nonresponders. When considering which patients fall under the umbrella of PDE-5i nonresponders, it is important to recognize that this definition includes a heterogeneous group of men. A 72-yr-old diabetic male who has been unresponsive to PDE-5i therapy for several years is different to a 55yr-old male who responds partially to PDE-5i therapy but is unable to have penetrative intercourse. It is therefore essential to consider baseline erectile function as well as patient expectations before treatment. Furthermore, proper counseling regarding optimizing PDE-5i therapy is important to truly consider a patient nonresponsive. Optimization of PDE-5i treatment entails applying sexual stimulation for appropriate nitric oxide release, reducing food intake (which may impair drug absorption), dose escalation as necessary, and repeated attempts. All four currently approved PDE-5i agents have demonstrated equivalent efficacy; however, given that various agents cross-react to other PDE-i drugs, this may lead to a varying side-effect profile and therefore switching agents may be warranted in cases of adverse reactions.
Journal of Urology, 2016
Purpose: We performed sham controlled evaluation of penile low intensity shock wave treatment effect in patients unable to achieve sexual intercourse using PDE5i (phosphodiesterase type 5 inhibitor). Materials and Methods: This prospective, randomized, double-blind, sham controlled study was done in patients with vasculogenic erectile dysfunction who stopped using PDE5i due to no efficacy. All patients had an erection hardness score of 2 or less with PDE5i. A total of 58 patients were randomized, including 37 treated with low intensity shock waves (12 sessions of 1,500 pulses of 0.09 mJ/mm 2 at 120 shock waves per minute) and 18 treated with a sham probe. In the sham group 16 patients underwent low intensity shock wave treatment 1 month after sham treatment. All patients were evaluated at baseline and 1 month after the end of treatment using validated erectile dysfunction questionnaires and the flow mediated dilatation technique for penile endothelial function. Erectile function was evaluated while patients were receiving PDE5i. Results: In the low intensity shock wave treatment group and the sham group 54.1% and 0% of patients, respectively, achieved erection hard enough for vaginal penetration, that is an EHS (Erection Hardness Score) of 3 (p <0.0001). According to changes in the IIEF-EF (International Index of Erectile Function-Erectile Function) score treatment was effective in 40.5% of men who received low intensity shock wave treatment but in none in the sham group (p ¼ 0.001). Of patients treated with shock waves after sham treatment 56.3% achieved erection hard enough for penetration (p <0.005). Conclusions: Low intensity shock wave treatment is effective even in patients with severe erectile dysfunction who are PDE5i nonresponders. After treatment about half of them were able to achieve erection hard enough for penetration with PDE5i. Longer followup is needed to establish the place of low intensity shock wave treatment in these challenging cases.
Andrologia, 2022
Low‐intensity shockwave therapy (LiSWT) has emerged as a promising non‐invasive treatment modality for erectile dysfunction (ED) yet the well‐designed randomized clinical trials are still lacking to prove its claimed benefits. A randomized, prospective, double‐blinded sham‐controlled study was conducted to evaluate the effectiveness and safety profile of short course LiSWT on vasculogenic ED patients. The International Index of Erectile Function‐5 (IIEF‐5) and Erection Hardness Score (EHS) questionnaires were used for evaluation. Patients underwent weekly sessions for 4 weeks and were re‐assessed at 1, 3 and 6 months post therapy. Fifty one patients were recruited and randomized into sham and treatment arms. The mean IIEF‐5 scores were significantly improved in the treatment arm compared to worsening of scores in the sham arm after 1 month (14.1 vs. 9.3 p < 0.001), 3 months (14.9 vs. 8.6, p < 0.001) and 6 months (14.2 vs. 7.9, p < 0.001) post treatment. A significant improvement of EHS was demonstrated at 1 month (2.4 vs. 1.8, p = 0.001, 3 months 2.7 vs. 1.7, p < 0.001) and 6 months (2.7 vs. 1.6, p < 0.001) in the treatment arm compared to sham arm. The success rate based on IIEF score increment more than five points was 26% in treatment arm and 0% in sham arm. Improvement in EHS score ≥3 in the treatment versus sham arm was 63% and 4%, respectively. There was no adverse effect reported. This 4‐week LiSWT protocol reflects better treatment compliance, and it prevents further deterioration of erectile function among this cohort of patients. This study proves that LiSWT is a well‐tolerated treatment with modest improvements in erectile function and hardness, among patients with vasculogenic ED.