Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction

Patel, Premal; Katz, Jonathan E.; Lokeshwar, Soum D.; Molina, Manuel; Reis, Isildinha M.; Clavijo, Raul I.; Ramasamy, Ranjith

doi:10.1016/j.esxm.2020.01.010

Cited by 12 publications

(3 citation statements)

References 28 publications

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“…Ramasamy et al performed a RCT comparing patients receiving 3,600 shocks over 1 week (n = 40) vs 2 weeks (n = 40) (Electromagnetic, MoreNova, DirexGroup, Israel, energy density of 0.09 mJ/mm 2 and frequency of 1Hz). 35 Both groups observed improved IIEF-EF and EHS scores, but there was no discernible difference in outcomes between the 2 groups. Kalyvianakis et al also compared session frequency and energy density (EFD) by randomizing 97 patients into 4 treatment groups: (2 sessions/week, EFD 0.05 mJ/mm 2 ), (3 sessions/week, EFD 0.05 mJ/mm 2 ), (2 sessions/week, EFD 0.10 mJ/mm 2 ), and (3 sessions/week, EFD 0.10 mJ/mm 2 ).…”

Section: Low-intensity Shock Wave Therapy (Liswt)mentioning

confidence: 82%

Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA)

et al. 2021

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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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Section: Low-intensity Shock Wave Therapy (Liswt)mentioning

confidence: 82%

Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA)

et al. 2021

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“…We must also consider treatment protocols which include potential variations in energy settings, number of applied shocks, and treatment duration. Patel et al found no difference in treatment success in their phase II trial comparing a similar number of shocks (3,600) delivered over one versus two weeks (56). Kalyvianakis et al similarly did not identify a significant difference in outcomes based on the number of sessions administered per week (two versus three) and varying energy-flux density (0.05 vs. 0.1 mJ/mm 2 ) (46).…”

Section: Discussionmentioning

confidence: 97%

Low-intensity shock wave therapy for the treatment of vasculogenic erectile dysfunction: a narrative review of technical considerations and treatment outcomes

Oliveira¹,

Ziegelmann²

2021

Transl Androl Urol

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Erectile dysfunction (ED) impacts a significant portion of the aging male population. Standard treatments such as oral medications, intracavernosal injections, intraurethral suppositories, vacuum erection aids, and penile prosthesis placement have stood the test of time. Recently, there has been a growing interest in the concept of regenerative medicine with the goal of restoring or renewing functional tissue. Low intensity shock wave therapy (LiSWT) is one example of a regenerative therapy. A strong body of basic science data suggests that shockwaves, when applied to local tissue, will encourage blood vessel and nerve regeneration. Clinical evidence supports the use of LiSWT to treat conditions ranging from ischemic heart disease, musculoskeletal injuries, and even chronic non-healing wounds. LiSWT is also being used to treat male sexual dysfunction conditions such as Peyronie's Disease and ED. The first studied application of LiSWT for ED was published in 2010. Since then multiple randomized, sham-controlled trials have sought to evaluate outcomes for this novel therapy in men with vasculogenic ED. Additionally, several meta-analyses are available with pooled data suggesting that LiSWT results in a significantly greater improvement in erectile function relative to sham-control. Despite these promising findings, the current body of literature is marred by significant heterogeneity relating to treatment protocols, patient populations, and follow-up duration. Further work is necessary to determine optimal device technologies, patient characteristics, and treatment duration prior to considering LiSWT as standard of care for men with ED.

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“…Prior SWT trials have shown efficacy with fSWT generators such as Direx MoreNova (27), Stortz Duolith SD1 (28,29), and Omnispec ED1000 (1,2,(27)(28)(29). Several meta-analyses have shown focused shockwave therapies to be clinically favorable in ED (8)(9)(10)(11).…”

Section: Discussionmentioning

confidence: 99%

Retrospective comparison of focused shockwave therapy and radial wave therapy for men with erectile dysfunction

Wu¹,

Ericson²,

Shoskes³

2020

Transl Androl Urol

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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: A retrospective chart review was performed to identify all men with ED treated by fSWT or rWT. Men with history suggesting non-vasculogenic ED were excluded. All men received 6 consecutive weekly treatments. The fSWT group received 3,000 shocks per treatment at 0.09 mJ/mm 2 . The rWT group received 10,000 shocks per treatment at 90 mJ and 15 Hz. Pre-treatment and 6-week post-treatment Sexual Health Inventory in Men (SHIM) scores were measured. Treatment response was categorized on a scale of 1-3 (1 if no improvement, 2 if erections sufficient for intercourse with phosphodiesterase 5 inhibitors (PDE5i), or 3 if sufficient erections without PDE5i). Primary endpoint was self-reported improvement score of 2 or greater.Results: A total of 48 men were included: 24 treated by fSWT and 24 by rWT. There were no significant differences in age, duration of ED, pre-treatment PDE5i use, or pre-treatment SHIM scores between the groups. Following treatment with rWT, the mean SHIM score improved from 9.3 to 16.1 (P<0.001). The mean SHIM following fSWT improved from 9.3 to 15.5 (P<0.001). The mean improvement in SHIM score did not differ between rWT (6.8) and fSWT (6.2) (P=0.42). 54% of men treated by fSWT experienced a significant clinical improvement (≥ grade 2 response) compared to 75% in the rWT group (P=0.42). There were no reported side effects with either device. Conclusions:In our patient population, both fSWT and rWT were moderately effective treatments for arteriogenic ED with no observable difference in efficacy between the two modalities.

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Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction

Cited by 12 publications

References 28 publications

Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA)

Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA)

Low-intensity shock wave therapy for the treatment of vasculogenic erectile dysfunction: a narrative review of technical considerations and treatment outcomes

Retrospective comparison of focused shockwave therapy and radial wave therapy for men with erectile dysfunction

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