Abstract:Background: Low-intensity shockwave therapy (SWT) is an emerging treatment for erectile dysfunction (ED). Devices used for SWT include focused shockwave therapy (fSWT) or radial wave therapy (rWT), which differ in how the waves are generated, their tissue penetration, and the shape of their pressure waves.Most studies of SWT for ED to date have utilized fSWT. Although widely used, the efficacy of rWT for ED is unknown. Our objective is to compare the efficacy of rWT and fSWT for ED at our institution.Methods: … Show more
“…rWT is commonly utilized in orthopedics, physical therapy, and dermatology (18)(19)(20)(21). The data supporting the use of rWT in ED is limited (22); at our institution the results of rWT treatment for men with vasculogenic ED was equivalent to fSWT (23). However, Sandoval-Salinas et al found no difference between rWT and sham (24).…”
Section: Introductionmentioning
confidence: 55%
“…Thus, these devices can be marketed as efficacious ED treatment despite limited supporting data (25). There are two recent studies that reported beneficial effects of rWT on ED (22,23). Wu et al retrospectively compared fSWT and rWT for treatment of men with vasculogenic ED; at 6 weeks after treatment, there were similar statistically and clinically significant improvements in IIEF-5 scores (23).…”
Background: Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Radial wave therapy (rWT), which differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy, is used to treat soft tissue and skin conditions and has some data to support its use in vasculogenic erectile dysfunction. There is limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. We report the first trial of rWT for penile rehabilitation after NS radical prostatectomy.Methods: We performed a prospective, non-randomized, open-label trial. Men with good pre-operative erectile function who underwent a NS radical prostatectomy at our institution from 2018-2020 were considered for inclusion. We compared post-operative erectile function outcomes between the rWT (6 weekly treatments initiated approximately 2 weeks post-operatively) plus standard of care (phosphodiesterase type 5 inhibitor) arm and the non-sham controlled standard of care arm. The primary end point for our study was the proportion of men who returned to "near normal" erectile function, defined as IIEF-5 score ≥17 and erectile hardness score (EHS) ≥3, by 3 months post-operatively between the intervention and control arm. We also compared mean IIEF-5 scores and median EHSs between the arms.Results: One hundred and six patients were enrolled, of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively. Five (17%) and 11 (26%) patients recovered erectile function in the control and intervention arms, respectively, which was not a statistically significant difference (P=0.37). However, the intervention arm did have a significantly higher median EHS compared to the control arm (1 vs. 2, P=0.03). There were 4 adverse events related to pain during treatment and required only treatment intensity de-escalation.Conclusions: rWT is safe but did not substantially improve the recovery of early erectile function after NS radical prostatectomy.
“…rWT is commonly utilized in orthopedics, physical therapy, and dermatology (18)(19)(20)(21). The data supporting the use of rWT in ED is limited (22); at our institution the results of rWT treatment for men with vasculogenic ED was equivalent to fSWT (23). However, Sandoval-Salinas et al found no difference between rWT and sham (24).…”
Section: Introductionmentioning
confidence: 55%
“…Thus, these devices can be marketed as efficacious ED treatment despite limited supporting data (25). There are two recent studies that reported beneficial effects of rWT on ED (22,23). Wu et al retrospectively compared fSWT and rWT for treatment of men with vasculogenic ED; at 6 weeks after treatment, there were similar statistically and clinically significant improvements in IIEF-5 scores (23).…”
Background: Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Radial wave therapy (rWT), which differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy, is used to treat soft tissue and skin conditions and has some data to support its use in vasculogenic erectile dysfunction. There is limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. We report the first trial of rWT for penile rehabilitation after NS radical prostatectomy.Methods: We performed a prospective, non-randomized, open-label trial. Men with good pre-operative erectile function who underwent a NS radical prostatectomy at our institution from 2018-2020 were considered for inclusion. We compared post-operative erectile function outcomes between the rWT (6 weekly treatments initiated approximately 2 weeks post-operatively) plus standard of care (phosphodiesterase type 5 inhibitor) arm and the non-sham controlled standard of care arm. The primary end point for our study was the proportion of men who returned to "near normal" erectile function, defined as IIEF-5 score ≥17 and erectile hardness score (EHS) ≥3, by 3 months post-operatively between the intervention and control arm. We also compared mean IIEF-5 scores and median EHSs between the arms.Results: One hundred and six patients were enrolled, of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively. Five (17%) and 11 (26%) patients recovered erectile function in the control and intervention arms, respectively, which was not a statistically significant difference (P=0.37). However, the intervention arm did have a significantly higher median EHS compared to the control arm (1 vs. 2, P=0.03). There were 4 adverse events related to pain during treatment and required only treatment intensity de-escalation.Conclusions: rWT is safe but did not substantially improve the recovery of early erectile function after NS radical prostatectomy.
“…Clinical and pre-clinical work in the literature has almost exclusively evaluated fSWT. 18–22 Despite categorical differences, and only preliminary studies comparing the two, fSWT and rWT, have been conflated by marketing platforms and transitively by patients; GAINSWave offers rWT, and yet both GAINSWave providers and other clinics in this cohort advertise SWT without specifying the discrepancy. The distinction between fSWT and rWT is clinically relevant.…”
Introduction:Due to the increasing prevalence of erectile dysfunction (ED) and pronounced distress for patients, a direct-to-consumer market for shock wave therapy (SWT) has emerged. We sought to evaluate trends in marketing and implementation of SWT as a restorative treatment for ED in large metropolitan areas by investigating cost to patients, provider credentials and treatment protocols.Methods:SWT providers in 8 of the most populous metropolitan areas were identified using Google search. Search queries included: “Shockwave therapy for erectile dysfunction in [city];” “Shockwave therapy for ED in [city];” and “GAINSWave in [city].” All clinics advertising SWT for ED within the boundaries of the selected metropolitan area were included. Using a “secret shopper” methodology, clinics were contacted by telephone with the goal of identifying the pricing, duration and provider administering the treatment.Results:Across 8 of the most populous cities in the U.S., 152 clinics offered SWT as a treatment for ED. Comprehensive information was available for 65% of the clinics; 25% of providers offering SWT were urologists while 13% were not physicians. The average price per treatment course was $3,338.28. Treatment duration was highly variable and ranged from 1 to indefinite courses based on individual patient circumstance.Conclusions:SWT, as a restorative therapy for ED, is performed primarily by nonurologists and is not standardized. Direct-to-consumer marketing is used to target distressed men. This study highlights concerning trends in major metropolitan markets, given the substantial financial impact for patients and inconsistent credentials among providers. Further, these findings suggest that patients are frequently seeking care for ED from nonurologists.
“… 20 , 25 This stark difference in depth of tissue penetrance and energy accounts for the regenerative effects LiSWT on the tissue level. Therefore, radial wave therapy cannot be compared to LiSWT 26 for management of ED as its disparate shock wave technology. Figure 1 LiSWT mechanism of action compared to radial wave therapy.…”
Introduction: Current non-invasive treatments for erectile dysfunction (ED) include oral medications, intracavernosal injections, and vacuum-assisted devices. Though these therapies work well for many, a subset of patients have contraindications or are unsatisfied with these options. Restorative therapies for ED are a new frontier of treatments focused on regenerating diseased tissue and providing a potential "cure" for ED. Aim: The aim of this position statement is to examine existing clinical trial data for restorative therapies and identify elements that require further research before widespread adoption. Methods: A literature review was performed to identify all clinical trials performed with regenerative therapy for ED. This includes treatments such as stem cell therapy (SCT), platelet rich plasma (PRP), and restorative related technologies like low-intensity shockwave therapy (LiSWT). Main Outcome Measures: Most clinical trials in restorative therapies were assessed for safety, feasibility, or efficacy. This included recording adverse events, changes in sexual function and erectile function questionnaires, and diagnostics measures. Results: To date there is an absence of robust clinical data supporting the efficacy of restorative therapies regarding ED, though technologies such as LiSWT have established relative safety. Conclusions: Restorative therapies are a promising technology that represents a new frontier of treatment geared towards reversing disease pathology rather than just treating symptoms. However, current published clinical studies are limited. Future work needs to be adequately powered, multi-center, randomized, sham/ placebo-controlled trials in well-characterized patient populations to ensure safety and demonstrate efficacy. Until these studies are done, restorative therapies should be reserved for clinical trials and not offered in routine clinical practice. Liu JL, Chu KY, Gabrielson AT, et al. Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA).
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