Low-Intensity Extracorporeal Shock Wave Therapy-A Novel Effective Treatment for Erectile Dysfunction in Severe ED Patients Who Respond Poorly to PDE5 Inhibitor Therapy (original) (raw)
Related papers
European urology, 2010
Background: Low-intensity extracorporeal shockwave therapy (LI-ESWT) is currently under investigation regarding its ability to promote neovascularization in different organs. Objective: To evaluate the effect of LI-ESWT on men with erectile dysfunction (ED) who have previously responded to oral phosphodiesterase type 5 inhibitors (PDE5-I). Design, setting, and participants: We screened 20 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 5-19 (average: 13.5) and abnormal nocturnal penile tumescence (NPT) parameters. Shockwave therapy comprised two treatment sessions per week for 3 wk, which were repeated after a 3-wk no-treatment interval. Intervention: LI-ESWT was applied to the penile shaft and crura at five different sites. Measurements: Assessment of erectile function was performed at screening and at 1 mo after the end of the two treatment sessions using validated sexual function questionnaires, NPT parameters, and penile and systemic endothelial function testing. The IIEF-ED questionnaire was answered at the 3-and 6-mo follow-up examinations. Results and limitations: We treated 20 middle-aged men (average age: 56.1 yr) with vasculogenic ED (mean duration: 34.7 mo). Eighteen had cardiovascular risk factors. At 1 mo follow-up, significant increases in IIEF-ED domain scores were recorded in all men (20.9 AE 5.8 vs 13.5 AE 4.1, p < 0.001); these remained unchanged at 6 mo. Moreover, significant increases in the duration of erection and penile rigidity, and significant improvement in penile endothelial function were demonstrated. Ten men did not require any PDE5-I therapy after 6-mo follow-up. No pain was reported from the treatment and no adverse events were noted during follow-up. Conclusions: This is the first study that assessed the efficacy of LI-ESWT for ED. This approach was tolerable and effective, suggesting a physiologic impact on cavernosal hemodynamics. Its main advantages are the potential to improve erectile function and to contribute to penile rehabilitation without pharmacotherapy. The short-term results are promising, yet demand further evaluation with larger sham-control cohorts and longer follow-up.
Sexual Medicine, 2016
Introduction: Low-intensity shockwave therapy (LISWT) has recently emerged as a promising method in the treatment of erectile dysfunction (ED). Aim: To 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. Methods: This 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 Measures: Effectiveness 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. Results: Eighty percent (mean age ¼ 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. Conclusion: LISWT 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.
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.
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.
Penile low-intensity shock wave therapy: a promising novel modality for erectile dysfunction
Korean journal of urology, 2014
Penile extracorporeal low-intensity shock wave therapy (LIST) to the penis has recently emerged as a novel and promising modality in the treatment of erectile dysfunction (ED). LIST has angiogenic properties and stimulates neovascularization. If applied to the corpora cavernosa, LIST can improve penile blood flow and endothelial function. In a series of clinical trials, including randomized double-blind sham-controlled studies, LIST has been shown to have a substantial effect on penile hemodynamics and erectile function in patients with vasculogenic ED. LIST is effective in patients who are responsive to phosphodiesterase 5 inhibitors (PDE5i) and can also convert PDE5i nonresponders to responders. The response to LIST wanes gradually over time, and after 2 years, about half of the patients maintain their function. Extensive research is needed to understand the effect of LIST on erectile tissue, to modify the treatment protocol to maximize its outcomes, and to identify the patients w...
Comparison of focused and unfocused ESWT in treatment of erectile dysfunction
The Aging Male, 2019
Recently, extracorporeal shock wave therapy (ESWT) is more commonly used in noninvasive treatment of erectile dysfunction (ED). There is no definitive treatment protocol on the use of ESWT. In this study, we aimed to compare focused and unfocused ESWT in ED. We created two groups, each including 20 patients with similar demographics. Focused ESWT is performed in one group, while unfocused ESWT is performed for the other group. Patients are assessed with IIEF-5 and EHS. Mean score of IIEF-5 was increased by 6.3 ± 3.3 (p < .05) from 9.6 ± 2.9 to 15.0 ± 5.0 in 3-month follow-up in the unfocused group. In the focused group, IIEF-5 score increased by 5.34 in average from 10.01 ± 2.5 to 15.4 ± 3.1. In conclusion, IIEF-5 score was significantly higher in the unfocused ESWT group than the focused ESWT group.
SOP Conservative (Medical and Mechanical) Treatment of Erectile Dysfunction
The Journal of Sexual Medicine, 2013
Introduction. Erectile dysfunction (ED) is the most frequently treated male sexual dysfunction worldwide. ED is a chronic condition that exerts a negative impact on male self-esteem and nearly all life domains including interpersonal, family, and business relationships. Aim. The aim of this study is to provide an updated overview on currently used and available conservative treatment options for ED with a special focus on their efficacy, tolerability, safety, merits, and limitations including the role of combination therapies for monotherapy failures. Methods. The methods used were PubMed and MEDLINE searches using the following keywords: ED, phosphodiesterase type 5 (PDE5) inhibitors, oral drug therapy, intracavernosal injection therapy, transurethral therapy, topical therapy, and vacuum-erection therapy/constriction devices. Additionally, expert opinions by the authors of this article are included. Results. Level 1 evidence exists that changes in sedentary lifestyle with weight loss and optimal treatment of concomitant diseases/risk factors (e.g., diabetes, hypertension, and dyslipidemia) can either improve ED or add to the efficacy of ED-specific therapies, e.g., PDE5 inhibitors. Level 1 evidence also exists that treatment of hypogonadism with total testosterone < 300 ng/dL (10.4 nmol/L) can either improve ED or add to the efficacy of PDE5 inhibitors. There is level 1 evidence regarding the efficacy and safety of the following monotherapies in a spectrum-wide range of ED populations: PDE5 inhibitors, intracavernosal injection therapy with prostaglandin E1 (PGE1, synonymous alprostadil) or vasoactive intestinal peptide (VIP)/phentolamine, and transurethral PGE1 therapy. There is level 2 evidence regarding the efficacy and safety of the following ED treatments: vacuum-erection therapy in a wide range of ED populations, oral L-arginine (3-5 g), topical PGE1 in special ED populations, intracavernosal injection therapy with papaverine/phentolamine (bimix), or papaverine/phentolamine/PGE1 (trimix) combination mixtures. There is level 3 evidence regarding the efficacy and safety of oral yohimbine in nonorganic ED. There is level 3 evidence that combination therapies of PDE5 inhibitors + either transurethral or intracavernosal injection therapy generate better efficacy rates than either monotherapy alone. There is level 4 evidence showing enhanced efficacy with the combination of vacuum-erection therapy + either PDE5 inhibitor or transurethral PGE1 or intracavernosal injection therapy. There is level 5 evidence (expert opinion) that combination therapy of PDE5 inhibitors + Larginine or daily dosing of tadalafil + short-acting PDE5 inhibitors pro re nata may rescue PDE5 inhibitor monotherapy failures. There is level 5 evidence (expert opinion) that adding either PDE5 inhibitors or transurethralPGE1 may improve outcome of penile prosthetic surgery regarding soft (cold) glans syndrome. There is level 5 evidence (expert opinion) that the combination of PDE5 inhibitors and dapoxetine is effective and safe in patients suffering