Low-intensity shockwave therapy (LiST) for erectile dysfunction: a randomized clinical trial assessing the impact of energy flux density (EFD) and frequency of sessions

Kalyvianakis, D.; Mykoniatis, Ioannis; Memmos, Evangelos; Kapoteli, P.; Memmos, Dimitrios; Hatzichristou, Dimitrios

doi:10.1038/s41443-019-0185-0

Cited by 11 publications

(8 citation statements)

References 24 publications

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“…Our results are consistent with prior studies which demonstrate a clinically significant improvement in IIEF-EF after Li-SWT. 24,25 Our study had a modest follow-up of 6 months which demonstrated an effective response. A recent study by Kitrey et al found 53.5% of patients had a sustained response to Li-ESWT after 2 years.…”

Section: Discussionmentioning

confidence: 83%

“…There are currently only 2 other randomized control trials investigating various LiSWT protocols, and both have shown comparable findings to this study. 24,25 The limitations of this phase II clinical trial study include the modest sample size, short follow-up, lack of a sham arm, stringent exclusion and inclusion criteria, and the inability to exclude psychogenic ED. Further studies investigating the treatment yield of Li-SWT on moderate ED patients vs mild ED patients in regard to MCID would elucidate whether the small increases in the IIEF-EF score are clinically relevant.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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Purpose: To evaluate safety and clinical response of Low-intensity Shockwave Therapy (Li-SWT) for the treatment of erectile dysfunction. Materials & Methods: A single-institution, 2 arm, phase II randomized clinical trial was conducted between February 2017 and April 2019. Patients were randomized into 2 groups, with Li-SWT delivering a total of 3,600 shocks over 5 days (720 once a day, Group A) or over 2 weeks (600 once a day, 3 times a week, Group B). Patients were evaluated for the safety of therapy and completed the International Index of Erectile Function-Erectile Function domain and the Erectile Hardness Scale assessment at baseline, and at 1, 3, and 6 months visits. Results: Among 87 evaluable patients, 45 and 42 were allocated to Groups A and B treatment schedules, respectively, and 80 patients (40 per group) completed the 6-month evaluation. No adverse events were reported during treatment or during follow-up. There were statistically significant (P < .05) improvements in International Index of Erectile Function-Erectile Function score (mean increase of 2.7 [95% CI ¼ 1.2, 4.2] and 2.7 points [95% CI ¼ 1.4, 4.1] for Groups A and B, respectively) and in Erectile Hardness Scale (mean increase of 0.6 points (95% CI ¼ 0.3, 0.8) and 0.5 (95% CI ¼ 0.2, 0.8) for Groups A and B, respectively) at 6 months, with no differences between groups. Conclusion: No difference in outcomes was found when Li-SWT 3,600 shocks were delivered over 1 or 2 weeks at 6 months follow-up and both schedules were safe with no adverse events during or after treatment. Further trials with longer follow-up and sham arm will provide valuable information regarding treatment efficacy and durability. Patel P, Katz J, Lokeshwar SD, et al. Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction. Sex Med 2020;8:214e222.

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Section: Discussionmentioning

confidence: 83%

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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“…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 ). 36 They found no significant differences between session frequency and EFD in MCID in IIEF- EF between groups, though there was a non-statistical significant trend towards EFD 0.10 mJ/mm 2 having better efficacy. Fojecki et al also compared 2 cycles of linear LiSWT vs 1 cycle of linear LiSWT (same device settings as their prior publication 21 ) and found no differences in IIEF-erectile function or EHS outcomes between the 2 treatment groups.…”

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

confidence: 88%

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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“…Of note, our findings are also in line with previous studies performed by our research team, applying the same LiST protocol. 13,25 A plethora of basic-research studies have suggested that LiST induces shear stress and endothelial damage which, in turn, leads to neoangiogenesis and remodeling of the corporal tissue. 26 LiST may improve erectile function by activating a regeneration cascade in the erectile tissue, vessels and nerves and by reversing the pathological processes of ED.…”

Section: Discussionmentioning

confidence: 99%

“…More specifically, 2,000 impulses were delivered to the corpora cavernosa, 2,000 to the crura cavernosa and 1,000 to the penile hila based on a protocol developed by our research team. 12–14…”

Section: Methodsmentioning

confidence: 99%

The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial

et al. 2022

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Low-intensity shockwave therapy (LiST) for erectile dysfunction: a randomized clinical trial assessing the impact of energy flux density (EFD) and frequency of sessions

Cited by 11 publications

References 24 publications

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

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

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

The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial

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