Treatment of Vasculogenic Erectile Dysfunction with Piezowave2 Device. Application of Low Intensity Shockwaves Using Novel Linear Shockwave Tissue Coverage (LSTC-ED&amp;lt;sup&amp;gt;&amp;amp;reg;&amp;lt;/sup&amp;gt;) Technique. A Prospective, Multicentric, Placebo-Controlled Study

Motil, Igor; Kubiš, Ivan; Šrámková, Taťána

doi:10.4236/asm.2016.62002

Cited by 14 publications

(14 citation statements)

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“…There are several reports of positive outcomes of LLi-ESWT for ED. 14 , 21 , 22 , 23 3 trials applied an electromagnetic device (Renova, Direx Systems GmbH, Wiesbaden, Germany). 21 , 22 , 23 Bechara et al 21 and Reisman et al 22 treated their patients with 3,600 SWs and an EFD of 0.09 mJ/mm 2 in 4 weeks, and Pelayo-Nieto et al 23 applied the same energy level but their treatment protocol consisted of 4 treatments of 5,000 SWs.…”

Section: Discussionmentioning

confidence: 99%

“… 21 , 22 , 23 Bechara et al 21 and Reisman et al 22 treated their patients with 3,600 SWs and an EFD of 0.09 mJ/mm 2 in 4 weeks, and Pelayo-Nieto et al 23 applied the same energy level but their treatment protocol consisted of 4 treatments of 5,000 SWs. Motil and Sramkova 14 tested the same piezoelectric therapy source used in the present study. Their treatment protocol involved 4 weekly sessions of 4,000 SWs, an EFD of 0.16 mJ/mm 2 , and a penetration depth of 10 to 15 mm.…”

Section: Discussionmentioning

confidence: 99%

“…Positive clinical effects were reported in all cited trials; however, only the study of Bechara et al 21 was designed as a randomized controlled trial and the others were open-label trials. 14 , 22 , 23 Considering those encouraging outcomes and absence of serious adverse effects, it seems safe to proceed with planning LLi-ESWT trials using a larger number of SWs. The advantage of linear ESWT is that usage of the linear probe delivers SWs to a wider area of the corpora cavernosa, thus limiting movements of the probe during treatment compared with focused ESWT, which could decrease user dependency.…”

Section: Discussionmentioning

confidence: 99%

“…The advantage of linear ESWT is that usage of the linear probe delivers SWs to a wider area of the corpora cavernosa, thus limiting movements of the probe during treatment compared with focused ESWT, which could decrease user dependency. 14 However, before clinical trials on ESWT in ED are performed, dose-finding studies defining the right protocol settings for the specific device tested should be mandatory, which to a large extent has been neglected in previous trials including ours. Recommending Li-ESWT as a treatment option for ED needs to be properly scientifically evaluated, because offering the treatment without evidence carries serious ethical issues.…”

Section: Discussionmentioning

confidence: 99%

“…Human clinical trials of Li-ESWT have produced inconsistent results. 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 A recent systematic review and meta-analysis concluded that Li-ESWT might be especially suitable for men with mild ED 5 ; yet 1 of the included trials only implicated a potential value for severe ED. 11 In addition, in several of the trials, an inconsistency was reported of ED outcome measures after Li-ESWT—International Index of Erectile Function (IIEF) vs Erectile Hardness Scale (EHS)—which are difficult to explain.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study

2017

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IntroductionShort-term data on the effect of low-intensity extracorporeal shockwave therapy (Li-ESWT) on erectile dysfunction (ED) have been inconsistent. The suggested mechanisms of action of Li-ESWT on ED include stimulation of cell proliferation, tissue regeneration, and angiogenesis, which can be processes with a long generation time. Therefore, long-term data on the effect of Li-ESWT on ED are strongly warranted.AimTo assess the outcome at 6 and 12 months of linear Li-ESWT on ED from a previously published randomized, double-blinded, sham-controlled trial.MethodsSubjects with ED (N = 126) who scored lower than 25 points in the erectile function domain of the International Index of Erectile Function (IIEF-EF) were eligible for the study. They were allocated to 1 of 2 groups: 5 weekly sessions of sham treatment (group A) or linear Li-ESWT (group B). After a 4-week break, the 2 groups received active treatment once a week for 5 weeks. At baseline and 6 and 12 months, subjects were evaluated by the IIEF-EF, the Erectile Hardness Scale (EHS), and the Sexual Quality of Life in Men.Main Outcome MeasuresThe primary outcome measure was an increase of at least 5 points in the IIEF-EF (ΔIIEF-EF score). The secondary outcome measure was an increase in the EHS score to at least 3 in men with a score no higher than 2 at baseline. Data were analyzed by linear and logistic regressions.ResultsLinear regression of the ΔIIEF-EF score from baseline to 12 months included 95 patients (dropout rate = 25%). Adjusted for the IIEF-EF score at baseline, the difference between groups B and A was −1.30 (95% CI = −4.37 to 1.77, P = .4). The success rate based on the main outcome parameter (ΔIIEF-EF score ≥ 5) was 54% in group A vs 47% in group B (odds ratio = 0.67, P = .28). Improvement based on changes in the EHS score in groups A and B was 34% and 24%, respectively (odds ratio = 0.47, P = .82).ConclusionExposure to 2 cycles of linear Li-ESWT for ED is not superior to 1 cycle at 6- and 12-month follow-ups.Fojecki GL, Tiessen S, Osther PJS. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study. Sex Med 2018;6:1–7.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study

2017

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Penile low intensity shock wave treatment for PDE5I refractory erectile dysfunction: a randomized double-blind sham-controlled clinical trial

et al. 2020

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Low-Intensity Shock Wave Therapy in Sexual Medicine—Clinical Recommendations from the European Society of Sexual Medicine (ESSM)

Capogrosso

Frey

Jensen

et al. 2019

The Journal of Sexual Medicine

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Introduction: Low-intensity shockwave therapy (LISWT) has been investigated for the treatment of uroandrological disorders including erectile dysfunction (ED), Peyronie's disease (PD) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with controversial findings. Aim: To review the evidence on LISWT for ED, PD, and CP/CPPS and provide clinical recommendations on behalf of the European Society of Sexual Medicine. Methods: Medline and Embase databases were searched for randomized clinical trials (RCTs), meta-analyses and open-label prospective or retrospective studies investigating the effect of LISWT on ED, PD, or CP/CPPS. Outcomes: The panel provided statements on clinically relevant questions concerning LISWT: (i) treatment efficacy, (ii) treatment protocol, (iii) clinical indications, and (iv) safety. The level of evidence was provided according to the Oxford 2011 criteria and graded using the Oxford Centre for Evidence-Based Medicine recommendations. Results: 11 RCTs and 5 meta-analyses investigated LISWT for ED. RCTs provided controversial results on the efficacy of LISWT and were affected by high heterogeneity and the small number of patients included. Pooleddata analysis showed an overall positive effect in terms of erectile function improvement but reported small estimates and included a largely heterogeneous cohort of patients. 4 RCTs and 1 meta-analysis assessed LISWT for PD. All trials showed positive findings in terms of pain relief but no effect on penile curvature and plaque size. Inclusion criteria vary widely among studies, and further investigation is needed. 5 RCTs investigated LISWT for CP/CPPS. Data showed a possible effect on pain relief, although there is no evidence supporting that pain relief was maintained or any improvement in pain over time. Clinical Implications: LISWT needs to be further investigated in the context of sexual medicine and is almost but not yet ready for clinical practice. Strengths and limitations: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. Conclusions: LISWT is a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation. Patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression. LISWT is not a primary treatment for CP/CPPS, but it may be

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Treatment of Vasculogenic Erectile Dysfunction with Piezowave2 Device. Application of Low Intensity Shockwaves Using Novel Linear Shockwave Tissue Coverage (LSTC-ED<sup>&reg;</sup>) Technique. A Prospective, Multicentric, Placebo-Controlled Study

Cited by 14 publications

References 5 publications

Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study

Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study

Penile low intensity shock wave treatment for PDE5I refractory erectile dysfunction: a randomized double-blind sham-controlled clinical trial

Low-Intensity Shock Wave Therapy in Sexual Medicine—Clinical Recommendations from the European Society of Sexual Medicine (ESSM)

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