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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>®</sup>) Technique. A Prospective, Multicentric, Placebo-Controlled Study

Advances in Sexual Medicine, 2016, 6, 15-18
Published Online April 2016 in SciRes.
How to cite this paper: Motil, I., Kubis, I. and Sramkova, T. (2016) Treatment of Vasculogenic Erectile Dysfunction with Pie-
Device. Application of Low Intensity Shockwaves Using Novel Linear Shockwave Tissue Coverage (LSTC-ED
) Tech-
nique. A Prospective, Multicentric, Placebo-Controlled Study. Advances in Sexual Medicine, 6, 15-18.
Treatment of Vasculogenic Erectile
Dysfunction with Piezowave
Application of Low Intensity Shockwaves
Using Novel Linear Shockwave Tissue
Coverage (LSTC-ED
) Technique.
A Prospective, Multicentric,
Placebo-Controlled Study
Igor Motil
, Ivan Kubis
, Tatana Sramkova
Urology and Andrology Center, Brno, Czech Republic
Urology and Andrology Center, Banska Bystrica, Slovakia
Department of Urology and Institute of Sexology, The 1st Facullty of Medicine, Charles University, Prague,
Czech Republic
Received 20 February 2016; accepted 4 April 2016; published 7 April 2016
Copyright © 2016 by authors and Scientific Research Publishing Inc.
This work is licensed under the Creative Commons Attribution International License (CC BY).
Low intensity shockwave (LiSW) treatment is known to improve revascularization. The method
has been evaluated and is used to treat vasculogenic erectile dysfunction (ED). The present study
aimed to demonstrate the efficacy of a linear focused piezoelectric shockwave device (Richard
) to treat patients with vasculogenic ED using a novel linear shockwave
tissue coverage LSTC-ED
technique. A total of 75 patients were treated using the Piezowave
vice and the LSTC-ED
technique. Patients’ erectile function was evaluated using the modified
IIEF-5 (International Index of Erectile Function) scale at the beginning of treatment and at 1
month post treatment; patients were additionally questioned using our own Treatment Satisfac-
tion Questionnaire (TSQ). The study also included a group of 50 patients treated by placebo; the
outcomes of both groups were compared. The average IIEF-5 score of patients in the treatment
group increased from 14.4 at baseline to 18.6 at 1 month post treatment. According to the IIEF-5
scale, treatment was successful in 81.33% of patients (61/75). According to the Treatment Satis-
faction Questionnaire (answers 1 to 3 of the TSQ), treatment was successful in 77.3% of patients
I. Motil et al.
(58/75). In the placebo group of 50 patients only 5 patients showed an improvement based on IIEF
score, and 8 reported an improvement based on their answers to the TSQ. No significant adverse
effects were observed during treatment or in the follow-up period. The Piezowave
device and the
technique proved to be suitable and effective to treat erectile dysfunction.
, Erectile Dysfunction, Extracorporeal Shockwaves,
Low Intensity Shockwave Therapy
1. Introduction
Erectile dysfunction (ED) is defined as inability to achieve or maintain erection adequate for sexual intercourse.
The association between vascular disease and erectile dysfunction has been recognized and well documented.
Alterations in the vascular hemodynamics are believed to be the most common cause of organic erectile dys-
function .Vascular diseases such as diabetes mellitus or atherosclerotic vascular occlusive disease are present in
up to 60% of ED patients.
It has been demonstrated that shockwaves can improve intrinsic angiogenic activity when used to treat
ischemic heart disease [1]. Current methods for treating vasculogenic ED aim to reduce symptoms rather than
reverse the cause of the disorder, which in most cases is due to disorders affecting arterial inflow, so the
use of
shockwaves to treat ED has been evaluated [2] [3] using a modified orthopedic device [4]. The present study
aims to assess the safety and efficacy of a shockwave device, the Piezowave² device of Richard Wolf GmbH,
which offers substantially superior treatment parameters and organ coverage using a new Linear Shockwave
Tissue Coverage LSTC-ED
The study was conducted in accordance with the principles of the Helsinki Declaration, and approved by the
Ministry of Health of the Czech Republic and by the 1st Faculty of Medicine, Charles University. The survey
was administered anonymously by trained researchers under the supervision of Institute of Sexology, the 1st
Faculty of Medicine, Charles University. All respondents gave consent to participate.
2. Patients and Methods
This study was a prospective, multicenter, placebo-controlled study. The study consisted of a screening phase, a
treatment phase and follow-up at 1 month. In the screening phase, 157 patients arrived for physical examination
and their medical history was recorded. Only heterosexual men aged between 36 and 71 years with vasculogenic
ED for at least 6 months, an International Index of Erectile Function (IIEF-5) score of 7 to 21 while on PDE5-I,
in a stable heterosexual relationship since at least 6 months were recruited to the study.
Vasculogenic ED was assessed by measuring of Cardio-ankle vascular index (CAVI) which is an excellent
indicator of arterial stiffness. CAVI has been widely applied clinically to assess arterial stiffness [5].
All 75 (+50 placebo group) recruited patients were responders to phosphodiesterase type 5 inhibitors
(PDE5-I) and use PDE5-I prior to and during the treatment as usual.
Exclusion criteria were hormonal, neurological or psychological pathology; prior radical prostatectomy; un-
stable medical, psychiatric and/or spinal cord injury; penile abnormality; clinically significant chronic hemato-
logical disease; use of anti-androgens, treatment for cancer in the past 5 years; radiotherapy of the pelvic region.
All patients completed the baseline evaluation questionnaire which consisted of 5 questions from the modified
This questionnaire consists of 5 questions on erectile function; the IIEF-5 scale ranges from 1 - 25 points,
with some level of ED considered to be present for scores below 21 points.
The newly designed TSQ questionnaire comprised the 4 questions shown below. This questionnaire had been
created by us to be able to evaluate treatment results and satisfaction more precisely and
it proved to be very
understandable for all patients.
Both questionnaires were also used to evaluate treatment one month after treatment had ended.
Treatment consisted of four weekly sessions using the LSTC-ED
technique. The technique covers the entire
I. Motil et al.
organ and was developed and introduced in 2014 at our department based on our experiences with appropriate
LiSW devices. In each session 4000 shocks of 0.16 mJ/mm
were applied. The wave focus penetration depth
was set to 10 - 15 mm. Shocks were applied to the corpora cavernosa (2000) and the crus of the penis (2000).
The treatment areas were the same in each session, so that by the end of the full course of treatment (4 sessions)
the total number of applied shocks was 16,000. Each session lasted 8.3 minutes, and the total treatment time was
33 minutes, with the total energy applied amounting to 2560 mJ.
50 patients in the placebo group were given the same treatment regimen; however, the device was switched
off and a typical shockwave sound recording (MP3 file) was played through external speakers. During treatment
as well as during the first month following treatment, all patients took PDE5-I where necessary. Follow-up was
done 1 month post treatment. The primary criterion of success was defined as an increase in IIEF-5 score from
baseline to follow-up at 1 month after treatment, with the severity of symptoms graded according to the
clinically important differences in the erectile function domain of the International Index of Erectile Function
scale (IIEF-5) [6], modified as shown in Table 1.
3. Assessed Device
The Piezowave
of Richard Wolf GmbH and Elvation Medical GmbH differs from other shockwave devices in
that it offers full organ coverage and superior treatment parameters. The device uses piezoelectric elements (ra-
ther than electrohydraulic or electromagnetic principles) to generate shockwaves and linear double layer tech-
nology to apply shockwaves to the target area. In linear shockwave therapy (LSWT), the treatment area is 46
mm long and 4 mm wide with a penetration depth into the target organ of 5 - 20 mm. Shocks are delivered at a
maximum rate of 480 PPM (8 Hz), resulting in shorter treatment sessions than with other shockwave devices.
These characteristics combined with the LSTC-ED
technique allowed sufficient energy to be applied to the
whole penile area in a very short space of time.
4. Results
157 patients were initially examined before patient selection. Finally a total of 75 (+50) middle-aged men (mean
age: 56.5 years, range: 35 - 70 years) with vasculogenic ED were recruited and finished the
study. There were
no drop-off patients.
71% of patients suffered from comorbidities such as diabetes (18%), hypertension (36%), dyslipidemia (21%)
or coronary heart disease (3%). According to results obtained with the IIEF-5 scale, treatment was successful in
81.33 % of patients (61/75).
Our original TSQ questionnaire consisted of 4 questions:
Q1. I was: 1) very satisfied; 2) fairly satisfied; 3) satisfied; 4) rather unsatisfied; 5) unsatisfied with the effect
of treatment;
Q2. Treatment was: 1) painless; 2) slightly uncomfortable; 3) neutral; 4) rather uncomfortable; 5) uncomfort-
Q3. My sexual life after the treatment is: 1) much better; 2) substantially improved; 3) better; 4) not much
improved; 5) not improved;
Q4. I would: 1) definitely recommend this treatment; 2) probably recommend this treatment; 3) recommend
this treatment; 4) rather not recommend this treatment; 5) not recommend this treatment to other patients.
Based on the answers to these questions, 58 of 75 patients (77.3%) showed themselves to be satisfied or very
Table 1. The success criteria of this study-modified from: Rosen RC, Allen
KR, Ni X, Araujo AB, Minimal clinically important differences in the erec-
tile function domain of the International Index of Erectile Function scale,
European Urology, November 2011, 60(5): 1010-1016.
IIEF-5 Baseline Score Success Factor
5 - 8 Improvement of 7 Points or More
9 - 14 Improvement of 5 Points or More
15 - 21 Improvement of 2 Points or More
I. Motil et al.
satisfied with the treatment received (answers 1 - 3). No patient reported significant pain during treatment, and
82% of patients stated that they would recommend this treatment to others.
In the placebo group only 5 patients (10%) showed an improvement in IIEF-5 score; based on the TSQ only 8
patients (16%) reported greater satisfaction after placebo treatment.
There were no complications or side effects during the treatment.
5. Discussions
Given that the reported success rate after treating patients with other comorbidities and an initial IIEF-5 score of
6 - 8 points is only around 20%, selecting eligible patients with vasculogenic ED suitable for treatment is cru-
We are currently working on the first unique algorithm which will allow us to customize treatment to each pa-
tient. The overall number of shocks applied will take factors into account that could influence the outcome of
treatment (e.g., degree of erectile dysfunction, blood sugar and lipid levels, smoking, etc.). We believe that this
tailored” treatment is right pathway for the future evolution of this treatment because it would not only reduce
costs but especially increase the efficacy.
The study is still ongoing, with more patients included and
further follow-ups are planned to evaluate the long
term duration of treatment efficacy as well as the long term safety and possibility of re-treatment
Patients will be evaluated after 3 and 6 months, than after 1 and 2 years. We expect the IIEF-5 score to have
increased by 3 - 6 months post treatment as has been reported in previous studies.
6. Conclusion
The results of this study indicate that Piezowave
and the LSTC-ED
technique are effective to treat mild to
moderate vasculogenic ED using low-intensity focused shockwaves. More studies are required to confirm the
safety and efficacy of this treatment. Particularly, we believe that in the future it is the most important to focus
on the unification of treatment parameters among different devices, techniques and to perform more multicen-
tric, placebo-controlled studies on this harmonized basis as well as to evaluate results with respect to our new
treatment algorithm developed for tailored treatment.
[1] Ito, K., Fukumoto, Y. and Shimokawa, H. (2009) Extracorporeal Shock Wave Therapy as a New and Non-Invasive
Angiogenic Strategy. The Tohoku Journal of Experimental Medicine, 219, 1-9.
[2] Vardi, Y., Appel, B., Jacob, G., Massarwi, O. and Gruenwald, I. (2010) Can Low-Intensity Extracorporeal Shockwave
Therapy Improve Erectile Function? A 6-Month Follow-Up Pilot Study in Patients with Organic Erectile Dysfunction.
European Urology, 58, 243-248.
[3] Vardi, Y., Appel, B., Kilchevsky, A. and Gruenwald, I. (2012) Does Low Intensity Extracorporeal Shockwave Therapy
Have a Physiological Effect on Erectile Function? Short-Term Results of a Randomized, Double-Blind, Sham Con-
trolled Study. The Journal of Urology, 187, 1769-1775.
[5] Sun, C.K. (2013) Cardio-Ankle Vascular Index (CAVI) as an Indicator of Arterial Stiffness. Integrated Blood Pressure
Control, 6, 27-38.
[6] Rosen, R.C., Allen, K.R., Ni, X. and Araujo, A.B. (2011) Minimal Clinically Important Differences in the Erectile
Function Domain of the International Index of Erectile Function Scale. European Urology, 60, 1010-1016.
... Since that time, multiple retrospective, single-arm prospective, and randomized-controlled trials have been published. This includes 11 randomized, sham-controlled trials evaluating the impact of LiSWT on men with vasculogenic ED ( Table 2) (32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42). Results are somewhat mixed owing in part to differences in patient populations, study design, outcomes assessed, follow-up duration, and the type of shockwave technology utilized. ...
... I n t o t a l , 7 / 1 1 ( 6 4 % ) s h a m -c o n t r o l l e d t r i a l s showed a statistically significant increase in IIEF scores in the treatment arm when compared with the control arm. IIEF scores (either IIEF-EF or IIEF-5) in the treatment arm ranged from +1-12.5 points, depending on the specific study (32,35,36,(38)(39)(40)(41)(42). 3/11 trials (27%) did not show a benefit favoring LiSWT over sham (33,34,37). ...
... Trials from Fojecki et al. and Olsen et al. similarly failed to show a significant difference in outcomes for LiSWT compared with sham-control (33,34). Motil and colleagues did not include a statistical analysis, but their results appear to favor LiSWT over sham, with >80% of patients in the treatment arm achieving a minimal clinically important difference (MCID) in IIEF scores (38). This refers to a change in IIEF scores based on the severity of underlying ED prior to treatment, as defined by Rosen et al. (43). ...
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.
... Three RCTs were comparing different treatment protocols of LI-ESWT for ED [35][36][37]. Finally, 10 RCTs with a total of 872 patients that compared LI-ESWT with sham-control treatment were included for metaanalysis [24][25][26][27][28][29][30][31][32][33] (Fig. 1). The mean number of participants per study was 87 (range 20-139), the mean age was 58 (range 27-81) years, and the mean follow-up was 5.12 months (range 1-12). ...
... They excluded patients with ED due to psychiatric, neurological, hormonal, or anatomical conditions, ED due to pharmacological treatment, and patients after pelvic surgery or irradiation. Two of the RCTs additionally defined vasculogenic ED using penile doppler duplex/triplex ultrasound [27,31] and one using cardio-ankle vascular index (CAVI) [29]. From the remaining studies, one RCT investigated LI-ESWT in EDpatients post nerve-sparing radical cystectomy [33], one RCT in kidney transplant recipients with ED [32], one RCT in patients with organic ED [30], one cohort in ED-patients post radical prostatectomy [18] and one cohort with ED of miscellaneous aetiology [20]. ...
... Most of the studies were considered to be of low risk of bias except 2 studies. The study by Motil et al. provided inadequate information regarding the randomisation as well as the blinding process, the outcome measures were only partially described, and the controlled treatment was performed with the device switched off with typical shockwave sound recording playing through external speakers, which could not allow blinding among the physicians [29]. The study by Srini et al. provided also inadequate information regarding the randomisation and blinding process, it had a very high dropout rate which was not adequately explained in the paper, and used statistically different groups at baseline in terms of ED and comorbidities [27]. ...
The efficacy of low intensity extracorporeal shock wave therapy (LI-ESWT) for erectile dysfunction (ED) has received hard criticism and recently published meta-analyses were not able to provide further insights, nor specific recommendations. The aim of this systematic review and meta-analysis is to evaluate the efficacy of LI-ESWT for ED, identify the ideal treatment population and treatment protocol, and provide recommendations for future research in the field. A systematic research for relevant clinical studies published from January 2010 to September 2018 was performed, using the following databases: Medline, Embase, The Cochrane Library, Scopus, and Web of Science. Only clinical studies that investigated the efficacy of LI-ESWT for ED only, and reported primary outcomes using IIEF-EF scores/questionnaires were included. Both, randomised controlled trials (RCTs) and cohort studies were included, but the meta-analysis was performed only for sham-controlled RCTs. Ten RCTs including 873 patients were selected for the meta-analysis. Pooling data of these studies showed that LI-ESWT could significantly improve erectile function in men with ED regarding both patient-subjective outcomes (IIEF-EF: +3.97; 95% CI [2.09–5.84]; p < 0.0001, EHS ≥ 3: OR: 4.35; 95% CI [1.82–10.37]; p = 0.0009) and patient-objective outcomes (peak systolic velocity: +4.12; 95% CI [2.30–5.94]; p < 0.00001). In conclusion, the present meta-analysis provided results showing that LI-ESWT significantly improves erectile function in patients with vasculogenic ED.
... 14,21e23 3 trials applied an electromagnetic device (Renova, Direx Systems GmbH, Wiesbaden, Germany). 21e23 Bechara et al 21 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. ...
... Results of previous trials 9, 12,14 suggested that PDE5i responders showed significantly improved erectile function. Our trial was not specifically powered to make distinctions between PDE5i responders and non-responders. ...
Full-text available
Introduction: Short-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. Aim: To assess the outcome at 6 and 12 months of linear Li-ESWT on ED from a previously published randomized, double-blinded, sham-controlled trial. Methods: Subjects 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 measures: The 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. Results: Linear 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). Conclusion: Exposure 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 2017;X:XXX-XXX.
... The Piezowave 2 provides focused and linear shockwaves with good precision, with easy operating modes and independent adjustment of the penetration depth and the intensity setting. It offers superior treatment parameters and organ coverage using a new linear shockwave tissue coverage technique (LSTC-ED) (Motil et al., 2016). ...
Full-text available
Low‐intensity shockwave therapy (LiSWT) has emerged as a promising non‐invasive treatment modality for erectile dysfunction (ED) yet the well‐designed randomized clinical trials are still lacking to prove its claimed benefits. A randomized, prospective, double‐blinded sham‐controlled study was conducted to evaluate the effectiveness and safety profile of short course LiSWT on vasculogenic ED patients. The International Index of Erectile Function‐5 (IIEF‐5) and Erection Hardness Score (EHS) questionnaires were used for evaluation. Patients underwent weekly sessions for 4 weeks and were re‐assessed at 1, 3 and 6 months post therapy. Fifty one patients were recruited and randomized into sham and treatment arms. The mean IIEF‐5 scores were significantly improved in the treatment arm compared to worsening of scores in the sham arm after 1 month (14.1 vs. 9.3 p < 0.001), 3 months (14.9 vs. 8.6, p < 0.001) and 6 months (14.2 vs. 7.9, p < 0.001) post treatment. A significant improvement of EHS was demonstrated at 1 month (2.4 vs. 1.8, p = 0.001, 3 months 2.7 vs. 1.7, p < 0.001) and 6 months (2.7 vs. 1.6, p < 0.001) in the treatment arm compared to sham arm. The success rate based on IIEF score increment more than five points was 26% in treatment arm and 0% in sham arm. Improvement in EHS score ≥3 in the treatment versus sham arm was 63% and 4%, respectively. There was no adverse effect reported. This 4‐week LiSWT protocol reflects better treatment compliance, and it prevents further deterioration of erectile function among this cohort of patients. This study proves that LiSWT is a well‐tolerated treatment with modest improvements in erectile function and hardness, among patients with vasculogenic ED.
... To this date, there is only 13 randomized placebo controlled clinical trials investigating LI-ESWT as a treatment for ED [9,10,21,[23][24][25][26][27][28][29][30][31]. Additionally, there has been five meta-analyses published regarding LI-ESWT studies [32][33][34][35][36]. ...
Full-text available
PurposeOver the last decade, penile low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a promising alternative for the treatment of erectile dysfunction (ED). The aim of this trial is to assess the effect of electromagnetic LI-ESWT on the erectile function of vascular phosphodiesterase type 5 inhibitor (PDE5I) refractory ED patients.Methods Randomized, double-blind, sham-controlled study. 76 patients with vascular PDE5I-refractory ED completed the study. 40 men were treated with LI-ESWT (1 session/week for 4 weeks, 5000 shocks/session, 0.09 mJ/mm2 energy density) and 36 were treated with a sham probe. Baseline and post-treatment (1, 3 and 6 months) evaluations were performed using validated erectile function questionnaires (IIEF-EF, EHS, SEP2, SEP3 and GAQ1). The groups were compared using Mann–Whitney–Wilcoxon and chi-squared tests, with results considered statistically significant at p < 0.05.ResultsAt the 3-month follow-up, median change in IIEF-EF score for active and sham groups was 3.5 (IQR 0–10) and − 0.5 (IQR − 11 to 1), respectively (p < 0.05). Six months after treatment, 52.5% of patients (21/40) in the active group and 27.8% of patients (10/36) in the sham group presented an EHS > 2 (p < 0.05). At the same evaluation, 40.0% (16/40) and 13.9% (5/36) of patients had positive answers to GAQ-1, in the treated and sham groups, respectively (p < 0.05). No adverse events were observed during the study.Conclusion This study showed that penile electromagnetic shockwave therapy may improve erectile function, to a modest extent, on certain patients that do not respond to PDE5I; making it an alternative for vascular ED patients that reject more invasive therapies.
... Several types of SW generators have been used; most of the studies were performed with focused SW generators, and only 2 RCTs used a linear generator. 10,15 There are no data directly comparing the 2 types of generators; in 1 meta-analysis the authors performed a sub-group analysis according to the type of generators used, reporting a significant improvement of the IIEF-EF only for studies applying focused SWs. 21 Overall, current evidence is too limited to draw final conclusions on the best SW generator. ...
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. Pooled-data 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 considered as an option to relieve pain. Capogrosso P, Frey A, Jensen CFS, et al. Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1490-1505.
... Since unfocused probe distributes shockwaves to a larger portion of corpus cavernosum than focused probe, restoration, and tissue regeneration are more efficiently stimulated in corpus cavernosum and moreover, user errors are less likely than focused ESWT [26]. ...
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.
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Introduction Although the literature of the positive effects of penile low intensity extracorporeal shockwave therapy is meanwhile substantial, there are substantial differences regarding both the sources of energies and extracorporeal shockwave therapy (ESWT) devices. Objectives To provide an overview on the energy range and energy differences of the 6 currently marketed ESWT devices along with personal ESWT experiences in 350 patients. Methods This review includes all published preclinical and clinical penile ESWT studies with evaluation of the technical differences of the 6 ESWT devices and the personal experiences with these 6 devices in ED and PD. The main outcomes measures were success rates in ED (International Index of Erectile Function-erectile function change, conversion of phosphodiesterase type 5 inhibitors non-responders) and PD (change in deviation and plaque size), differences of used sources of energy, and energy flux densities (EFDs). Results 3 different sources of energies are used, that is electromagnetic, electrohydraulic, and piezoelectric .The devices markedly distinguish in the available spectrum of the EFD ranging between 0.09 and 0.55 mJ/mm². In terms of the biological effects, the relevant energy parameters are −6 dB and the 5 MPa focus, which differ substantially between the ESWT devices. In addition, a great variability in the treatment protocols and applied energy is obvious. The preliminary own experiences with low intensity extracorporeal shockwave therapy in 160 ED non-responders and 190 patients with PD with success rates of 45% and 47%, respectively, are reported. Conclusion Positive results were published with all 6 ESWT devices in question in patients with organic ED but with huge differences regarding the EFD and the total energies applied. There is growing evidence that concentrated treatment protocols and increasing energies may yield better results. In this context, it may be argued that at least some of the published studies were markedly underpowered .Owing to the paucity of published studies, the literature of the effects of ESWT in PD and for penile rehabilitation after pelvic surgery is currently not conclusive. Porst H. Review of the Current Status of Low Intensity Extracorporeal Shockwave Therapy (Li-ESWT) in Erectile Dysfunction (ED), Peyronie's Disease (PD), and Sexual Rehabilitation After Radical Prostatectomy With Special Focus on Technical Aspects of the Different Marketed ESWT Devices Including Personal Experiences in 350 Patients. Sex Med 2020;XX:XXX–XXX.
Erectile dysfunction (ED) is defined as the inability to attain and maintain erection of the penis sufficient to permit satisfactory sexual activity. ED most commonly affects men from 40 years of age with a clear age-associated increase in prevalence. The condition may have significant negative impact on quality of life for both the patients and their partners. Over recent years, low-intensity shockwave therapy (LIST) has gained popularity in the treatment of ED, based on the assumption that LIST application may result in neoangiogenesis and thus increased blood flow to the corpora cavernosa. The increasing usage of LIST is contrasting with current guidelines, with the EAU guideline on ED stating that LIST can be used in mild organic ED patients or poor responders to PDE5I’s, but with a weak strength of recommendation. In the AUA guideline on ED, the panel makes a conditional recommendation of grade C that LIST should be considered investigational. In this review, we will briefly review practice patterns, and critically discuss the evidence based on which these guideline statements have been made.
Introduction Current treatment for erectile dysfunction (ED) mostly attempts to improve erectile function with limited impact on altering the underlying pathophysiology of ED. Recent animal experiments have supported the notion that low intensity extracorporeal shockwave therapy (LIESWT) significantly improves penile hemodynamics and might induce structural changes that regenerate penile tissue. Areas covered This review article provides an overview of the basic mechanics and clinical studies pertaining to LIESWT and its use in the field of ED. We identify several key aspects of LIESWT and compare contemporary LIESWT machines and their clinical outcomes. Expert opinion/commentary There is emerging and strong literature to support the use of LIESWT in men with ED, with many clinical studies reported encouraging results in the use of LIESWT with improved erectile function, good safety records, and short-term durability. However, there is a need to define which subgroup of ED population is best suited and the LIESWT treatment protocol including LIESWT template, modality of shock waves energy, emission frequency, and total energy delivery. More stringent randomised controlled trials are warranted before there is widespread acceptance of this LIESWT technology as the standard of care in ED.
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Arterial stiffness has been identified as an independent predictor of prognostic outcomes for patients with cardiovascular disease. Although measurement of pulse wave velocity has been a widely accepted noninvasive approach to the assessment of arterial stiffness, its accuracy is hampered by changes in blood pressure. Taking the exponential relation between intravascular pressure and arterial diameter into consideration, a stiffness parameter can be obtained by plotting the natural logarithm of systolic-diastolic pressure ratio against the arterial wall extensibility. Cardio-ankle vascular index (CAVI), which is calculated based on the stiffness parameter thus obtained, is theoretically independent of changes in blood pressure. With this distinct advantage, CAVI has been widely applied clinically to assess arterial stiffness in subjects with known cardiovascular diseases including those with diagnosed atherosclerosis, coronary heart disease, and stroke as well as those at risk, including those with hypertension, diabetes, the elderly, and the obese. Because of its enhanced sensitivity, not only has the index been used to discern subtle changes in the disease process, it has also been utilized in studying normal individuals to assess their potential risks of developing cardiovascular diseases. The primary aims of assessing arterial stiffness using CAVI are not only to aid in early detection of arteriosclerosis to allow timely treatment and change in lifestyle, but also to quantitatively evaluate the progression of disease and the effectiveness of treatment. Despite its merit of being unaffected by blood pressure, discretion in data interpretation is suggested because an elevated CAVI represents not just vascular stiffness caused by pathological changes in the arterial wall, but can also be attributed to an increased vascular tone brought about by smooth muscle contraction. Moreover, certain patient populations, such as those with an ankle-brachial index < 0.9, may give falsely low CAVI and are suggested to be excluded from study.
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Ischemic heart disease is the leading cause of death and the number of refractory severe patients is increasing. Therefore, it is crucial to develop new therapeutic strategies for severe ischemic heart disease. We found that a low-energy shock wave (SW) (about 10% of energy density that used for urolithiasis) effectively increases the expression of vascular endothelial growth factor (VEGF) in cultured endothelial cells. Based on this in vitro study, we have started in vivo studies and have demonstrated that extracorporeal cardiac shock wave therapy with a low-energy SW upregulates the expression of VEGF, induces neovascularization, and improves myocardial ischemia in a porcine model of chronic myocardial ischemia without any adverse effects in vivo. On the basis of the promising results in animal studies, we have subsequently developed a new, non-invasive angiogenic therapy with low-energy SW for ischemic heart disease. Our extracorporeal cardiac SW therapy improved symptoms and myocardial perfusion evaluated with stress-scintigraphy in patients with severe coronary artery disease without indication of percutaneous coronary intervention or coronary bypass surgery. Importantly, no procedural complications or adverse effects were noted. The SW therapy was also effective to ameliorate LV remodeling after acute myocardial infarction in pigs and to enhance angiogenesis in hindlimb ischemia in rabbits. Based on these animal studies, we are also conducting clinical studies in patients with acute myocardial infarction and those with peripheral artery disease. Thus, our extracorporeal cardiac SW therapy is an effective, safe, and non-invasive angiogenic strategy in cardiovascular medicine and its indication is now rapidly expanding.
We investigated the clinical and physiological effect of low intensity extracorporeal shock wave therapy on men with organic erectile dysfunction who are phosphodiesterase type 5 inhibitor responders. After a 1-month phosphodiesterase type 5 inhibitor washout period, 67 men were randomized in a 2:1 ratio to receive 12 sessions of low intensity extracorporeal shock wave therapy or sham therapy. Erectile function and penile hemodynamics were assessed before the first treatment (visit 1) and 1 month after the final treatment (followup 1) using validated sexual function questionnaires and venoocclusive strain gauge plethysmography. Clinically we found a significantly greater increase in the International Index of Erectile Function-Erectile Function domain score from visit 1 to followup 1 in the treated group than in the sham treated group (mean ± SEM 6.7 ± 0.9 vs 3.0 ± 1.4, p = 0.0322). There were 19 men in the treated group who were initially unable to achieve erections hard enough for penetration (Erection Hardness Score 2 or less) who were able to achieve erections sufficiently firm for penetration (Erection Hardness Score 3 or greater) after low intensity extracorporeal shock wave therapy, compared to none in the sham group. Physiologically penile hemodynamics significantly improved in the treated group but not in the sham group (maximal post-ischemic penile blood flow 8.2 vs 0.1 ml per minute per dl, p <0.0001). None of the men experienced discomfort or reported any adverse effects from the treatment. This is the first randomized, double-blind, sham controlled study to our knowledge that shows that low intensity extracorporeal shock wave therapy has a positive short-term clinical and physiological effect on the erectile function of men who respond to oral phosphodiesterase type 5 inhibitor therapy. The feasibility and tolerability of this treatment, coupled with its potential rehabilitative characteristics, make it an attractive new therapeutic option for men with erectile dysfunction.
Despite widespread adoption of the six-item erectile function (EF) domain of the International Index of Erectile Function (IIEF) as a clinical trial end point, there are currently no objective data on what constitutes a minimal clinically important difference (MCID) in the EF domain. Estimate the MCID for the IIEF EF domain. Anchor-based MCIDs were estimated using data from 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials of the phosphodiesterase type 5 inhibitor (PDE5-I) tadalafil for 3345 patients treated for 12 wk. The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7: "Over the past 4 weeks, when you attempted sexual intercourse how often was it satisfactory for you?" MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies (n=11) by comparing patients with and without minimal improvement (n=863). MCIDs were validated in the remaining six studies (n=377). The ROC-based MCID for the EF domain was 4, with estimated sensitivity and specificity of 0.74 and 0.73, respectively. MCIDs varied significantly (p<0.0001) according to baseline ED severity (mild: 2; moderate: 5; severe: 7). MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region, ED etiology, and age group. MCIDs did not differ by age group, geographic region, or ED etiology. Current analyses were based on 17 clinical trials of tadalafil. Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies. The contextualization of treatment-related changes in terms of clinically relevant improvement is essential to understanding treatment efficacy, to interpreting results across studies, and to managing patients effectively. This analysis provides, for the first time, anchor-based estimates of MCIDs in the EF domain score of the IIEF.
Low-intensity extracorporeal shockwave therapy (LI-ESWT) is currently under investigation regarding its ability to promote neovascularization in different organs. 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). 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. LI-ESWT was applied to the penile shaft and crura at five different sites. 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. 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 +/- 5.8 vs 13.5+/- 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. 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.