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Article ; Online: Radiofrequency energy in the treatment of erectile dysfunction-a novel cohort pilot study on safety, applicability, and short-term efficacy.

Gruenwald, Ilan / Appel, Boaz / Shechter, Arik / Greenstein, Alexander

International journal of impotence research

2023

Abstract: The erectile mechanism depends, in part on the intactness of the collagen components in the penis. As such, impaired collagen may have a deleterious effect on erectile function. Radiofrequency energy has been shown to renew and restore spatial structural ...

Abstract	The erectile mechanism depends, in part on the intactness of the collagen components in the penis. As such, impaired collagen may have a deleterious effect on erectile function. Radiofrequency energy has been shown to renew and restore spatial structural arrangement of collagen fibers; therefore, treatment of erectile dysfunction with radiofrequency could lead to anatomical and physiological changes at the penile tissue level and could lead to improvement in the erectile mechanism. We conducted this study to assess the effect of radiofrequency treatment on erection quality. We evaluated the safety, applicability, and efficacy of a self-applied, handheld, low-intensity radiofrequency device (Vertica®) in men with moderate and mild-to-moderate organic erectile dysfunction. The treatment protocol consisted of 12 treatments (twice a week during the 1st month, and once a week during the 2nd month), and each participant treated himself individually. Treatment outcomes were evaluated using the International Index of Erectile Function, Erection Hardness Scale, Erectile Dysfunction Index of Treatment Satisfaction, Benefit, Satisfaction & Willingness to continue, Quality of Erection Questionnaire, Sexual Quality of Life questionnaires and specific questions addressing side effects and ease of use. Twenty-eight out of 32 men (mean age 59.5 ± 9.8, range: 41-78 years) completed a one-month follow-up after treatment. Mean International Index of Erectile Function (43.7. ± 7.8 vs. 60.9 ± 10.8, p < 0.01), International Index of Erectile Function -Erection Function domain (16.8 ± 3.1 vs. 24.4 ± 4.4, p < 0.001), and Erection Hardness Scores (2.2 ± 0.8 vs. 3.2 ± 0.5, p = 0.01) were all significantly improved. Fifty percent of patients achieved normal erectile function parameters according to the International Index of Erectile Function -Erection Function domain score >25. High mean scores were achieved in the Erectile Dysfunction Index of Treatment Satisfaction (76.8 ± 20.3), Benefit, Satisfaction & Willingness to continue (4.83 ± 1.1), Quality of Erection Questionnaire (73.4 ± 23.8), and Sexual Quality of Life (67 ± 29.4) questionnaires. No side effects were reported and participants rated the device as very comfortable, simple, and easy to operate.
Language	English
Publishing date	2023-08-17
Publishing country	England
Document type	Journal Article
ZDB-ID	1034295-3
ISSN	1476-5489 ; 0955-9930
ISSN (online)	1476-5489
ISSN	0955-9930
DOI	10.1038/s41443-023-00733-1
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Article ; Online: A novel on-demand therapy for lifelong premature ejaculation using a miniature transperineal electrical stimulator-the vPatch: an as-treated analysis.

Shechter, Arik / Mondaini, Nicola / Serefoglu, Ege Can / Gollan, Tal / Deutsch, Frederic / Appel, Boaz / Gruenwald, Ilan

The journal of sexual medicine

2023 Volume 20, Issue 1, Page(s) 22–29

Abstract: Background: While premature ejaculation (PE) is a common and disturbing sexual dysfunction in men, current available treatment modalities have limited efficacy and low treatment adherence.: Aim: To assess the feasibility, safety, and efficacy of the ... ...

Abstract	Background: While premature ejaculation (PE) is a common and disturbing sexual dysfunction in men, current available treatment modalities have limited efficacy and low treatment adherence. Aim: To assess the feasibility, safety, and efficacy of the vPatch, a miniaturized on-demand perineal transcutaneous electrical stimulation device for treating PE. Methods: This prospective bicenter international first-in-human clinical study consisted of 2 arms, was sham controlled, and had a randomized double-blind design. In terms of statistical power calculation, 59 patients aged 21 to 56 years (mean ± SD, 39.8 ± 9.28) with lifelong PE were included. During the initial visit, intravaginal ejaculatory latency time (IELT) was measured over a 2-week run-in period. Eligibility was confirmed in visit 2, based on IELT values, medical and sexual history, and patients' individualized sensory and motor activation thresholds during perineal stimulation with the vPatch. Patients were randomized to the active (vPatch) and sham device groups in a 2:1 ratio, respectively. The vPatch device's safety profile was determined by comparing the incidence of treatment-emergent adverse events. During visit 3, IELTs, Clinical Global Impression of Change scores, and Premature Ejaculation Profile questionnaire outcomes were recorded. Primary end points assessed vPatch device efficacy as mean change in geometric mean IELT; each person was compared with himself, with and without the device, and the sham group was compared with the active group. Outcomes: Outcomes included changes in IELT and Premature Ejaculation Profile before and after treatment, last visit Clinical Global Impression of Change scores, and vPatch safety profile. Results: Of 59 patients, 51 completed the study: 34 in the active group and 17 in the sham group. The baseline geometric mean IELT significantly increased from 67 to 123 seconds (P < .01) in the active group, as compared with an insignificant increase from 63 to 81 seconds (P = .17) in the sham group. The increase in mean IELT in the active group was significantly higher than in the sham group (56 vs 18 seconds, P = .01). IELT significantly increased by 3.1 times in the active vs sham group. The mean ratio of fold change (active:sham) was 1.4, significantly different from 1.0 (P = .02). No serious adverse events were reported. Clinical implications: Therapeutic use of the vPatch during coitus may become an on-demand, noninvasive, and drug-free treatment for PE. Strengths and limitations: To our knowledge, this is the first rigorous study investigating whether transcutaneous electrical stimulation during coitus could improve the symptoms of men with lifelong PE. The study is limited by the small number of patients, the exclusion of patients with acquired PE, the short-term follow up, and the use of a device based on a theoretic mechanism of action. Conclusion: We demonstrated the possibility to treat lifelong PE by prolonging coitus on demand, using electric stimulation of ejaculation muscles with the vPatch.Clinical trial registration: NCT03942367 (ClinicalTrials.gov).
MeSH term(s)	Male ; Humans ; Premature Ejaculation/drug therapy ; Prospective Studies ; Ejaculation/physiology ; Coitus ; Sexual Behavior
Language	English
Publishing date	2023-03-10
Publishing country	Netherlands
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2251959-2
ISSN	1743-6109 ; 1743-6095
ISSN (online)	1743-6109
ISSN	1743-6095
DOI	10.1093/jsxmed/qdac012
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Article ; Online: Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients.

Spivak, Leonid / Shultz, Tamar / Appel, Boaz / Verze, Paolo / Yagudaev, David / Vinarov, Andrei

Sexual medicine reviews

2019 Volume 9, Issue 4, Page(s) 619–627

Abstract: Introduction: The cause of erectile dysfunction (ED) in diabetic patients is complex and involves both neurogenic and vasculogenic components and is often hard to treat.: Aim: To study the effect of low-intensity extracorporeal shock wave therapy (Li- ...

Abstract	Introduction: The cause of erectile dysfunction (ED) in diabetic patients is complex and involves both neurogenic and vasculogenic components and is often hard to treat. Aim: To study the effect of low-intensity extracorporeal shock wave therapy (Li-ESWT) therapy on a subgroup of diabetic patients with ED who are responders (PDE5I-R) and non-responders (PDE5I-NR) to phosphodiesterase 5 inhibitors (PDE5I). Methods: Analysis of pooled data from 5 double-blind, sham-controlled trials was performed. In this sub-analysis, of 350 patients in the PDE5I-R group and with vasculogenic ED, we found 61 patients with diabetes mellitus who underwent LI-ESWT. Another 48 patients (of 53) belonged to the PDE5I-NR group. Baseline efficacy was evaluated with the International Index of Erectile Function-Erectile Function domain questionnaire (IIEF-EF) for the PDE5I-R and with Erection Hardness Score, IIEF-EF, and flow-mediated dilation technique for the PDE5I-NR. Main outcome measures: Change in the IIEF-EF score after treatment of diabetes-induced ED with Li-ESWT in the PDE5i-R group vs the PDE5i-NR group. Results: LI-ESWT therapy was found to be effective in both subgroups of diabetic patients. Minimally clinical important difference in IIEF-EF score was achieved in 50%, 79.5%, 77.3%, and 65.9% of the subjects in the active group in after the sixth shockwave (SW) treatment evaluation (just before initiating the seventh SW session) and at 1 month, 6 months, and 12 months after the last SW treatment, respectively. The difference among the groups was significant (P < .05) after the sixth treatment and in all the follow-up periods. In the PDE5I-NR group, 55% of the active group were converted to PDE5I-5-R after LI-ESWT. The difference between the active and sham groups was statistically significant in all the tested measures (P < .001). Conclusion: LI-ESWT is safe and effective for the treatment of ED in PDE5I-R and PDE5I-NR groups. Spivak L, Shultz T, Appel B, et al. Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction in Diabetic Patients. Sex Med Rev 2021;9:619-627.
MeSH term(s)	Diabetes Mellitus ; Erectile Dysfunction/therapy ; Extracorporeal Shockwave Therapy ; Humans ; Male ; Penile Erection ; Phosphodiesterase 5 Inhibitors/therapeutic use ; Randomized Controlled Trials as Topic
Chemical Substances	Phosphodiesterase 5 Inhibitors
Language	English
Publishing date	2019-08-01
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2722257-3
ISSN	2050-0521 ; 2050-0513
ISSN (online)	2050-0521
ISSN	2050-0513
DOI	10.1016/j.sxmr.2019.06.007
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Article ; Online: Transcutaneous functional electrical stimulation-a novel therapy for premature ejaculation: results of a proof of concept study.

Shechter, Arik / Serefoglu, E C / Gollan, Tal / Springer, Shmuel / Meiry, Gideon / Appel, Boaz / Gruenwald, Ilan

International journal of impotence research

2019 Volume 32, Issue 4, Page(s) 440–445

Abstract: Premature Ejaculation (PE) is a very common and disturbing sexual dysfunction in men. Currently available treatment modalities are associated with limited efficacy and low treatment adherence. In this prospective, single-blinded, self-controlled study, ... ...

Abstract	Premature Ejaculation (PE) is a very common and disturbing sexual dysfunction in men. Currently available treatment modalities are associated with limited efficacy and low treatment adherence. In this prospective, single-blinded, self-controlled study, we evaluated the efficacy and safety of transcutaneous electrical stimulation (TES) for the treatment of (PE). We included 23 patients aged 20-60 (mean: 38.7) with lifelong PE. On the first visit, we delivered either TES or sham treatment to the perineum, based on the enrollment order. For stimulation, we used a commercial neuromuscular electrical stimulation device. The patients were invited for the second visit after at least 7 days for receiving the alternating treatment. During the treatment sessions, the patients were left alone in a privet silent room to masturbate and a stopwatch was used to measure their masturbation ejaculatory latency time (MELT). The patients also filled-out safety questionnaires after each visit and on each of the 3 following days. Of the 20 patients who completed the study, 17 (85%) experienced prolonged MELT under TES compared with the sham treatment. Mean MELT values increased 3.5-folds under TES (p = 0.0009). We demonstrated a significant increase in MELT in lifelong PE patients using TES. This therapeutic option may have the potential to become an on-demand treatment option for PE. Future studies with wireless devices are needed to confirm the efficacy and safety of this treatment concept during intercourse.
MeSH term(s)	Adult ; Ejaculation ; Electric Stimulation ; Humans ; Male ; Middle Aged ; Premature Ejaculation/therapy ; Proof of Concept Study ; Prospective Studies ; Transcutaneous Electric Nerve Stimulation ; Young Adult
Language	English
Publishing date	2019-09-30
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	1034295-3
ISSN	1476-5489 ; 0955-9930
ISSN (online)	1476-5489
ISSN	0955-9930
DOI	10.1038/s41443-019-0207-y
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Article ; Online: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study.

Vardi, Yoram / Appel, Boaz / Kilchevsky, Amichai / Gruenwald, Ilan

The Journal of urology

2012 Volume 187, Issue 5, Page(s) 1769–1775

Abstract: Purpose: 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.: Materials and methods: After a 1-month ... ...

Abstract	Purpose: 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. Materials and methods: 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. Results: 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. Conclusions: 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.
MeSH term(s)	Combined Modality Therapy ; Double-Blind Method ; Erectile Dysfunction/drug therapy ; Erectile Dysfunction/physiopathology ; Erectile Dysfunction/therapy ; Humans ; Male ; Penis/physiopathology ; Phosphodiesterase 5 Inhibitors/therapeutic use ; Pilot Projects ; Ultrasonic Therapy/methods
Chemical Substances	Phosphodiesterase 5 Inhibitors
Language	English
Publishing date	2012-05
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3176-8
ISSN	1527-3792 ; 0022-5347
ISSN (online)	1527-3792
ISSN	0022-5347
DOI	10.1016/j.juro.2011.12.117
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Article ; Online: Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy.

Gruenwald, Ilan / Appel, Boaz / Vardi, Yoram

The journal of sexual medicine

2012 Volume 9, Issue 1, Page(s) 259–264

Abstract: Introduction: Low-intensity shock wave therapy (LI-ESWT) has been reported as an effective treatment in men with mild and moderate erectile dysfunction (ED).: Aim: The aim of this study is to determine the efficacy of LI-ESWT in severe ED patients ... ...

Abstract	Introduction: Low-intensity shock wave therapy (LI-ESWT) has been reported as an effective treatment in men with mild and moderate erectile dysfunction (ED). Aim: The aim of this study is to determine the efficacy of LI-ESWT in severe ED patients who were poor responders to phosphodiesterase type 5 inhibitor (PDE5i) therapy. Methods: This was an open-label single-arm prospective study on ED patients with an erection hardness score (EHS) ≤ 2 at baseline. The protocol comprised two treatment sessions per week for 3 weeks, which were repeated after a 3-week no-treatment interval. Patients were followed at 1 month (FU1), and only then an active PDE5i medication was provided for an additional month until final follow-up visit (FU2). At each treatment session, LI-ESWT was applied on the penile shaft and crus at five different anatomical sites (300 shocks, 0.09 mJ/mm(2) intensity at 120 shocks/min). Each subject underwent a full baseline assessment of erectile function using validated questionnaires and objective penile hemodynamic testing before and after LI-ESWT. Main outcome measures: Outcome measures used are changes in the International Index of Erectile Function-erectile function domain (IIEF-ED) scores, the EHS measurement, and the three parameters of penile hemodynamics and endothelial function. Results: Twenty-nine men (mean age of 61.3) completed the study. Their mean IIEF-ED scores increased from 8.8 ± 1 (baseline) to 12.3 ± 1 at FU1 (P = 0.035). At FU2 (on active PDE5i treatment), their IIEF-ED further increased to 18.8 ± 1 (P < 0.0001), and 72.4% (P < 0.0001) reached an EHS of ≥ 3 (allowing full sexual intercourse). A significant improvement (P = 0.0001) in penile hemodynamics was detected after treatment and this improvement significantly correlated with increases in the IIEF-ED (P < 0.05). No noteworthy adverse events were reported. Conclusions: Penile LI-ESWT is a new modality that has the potential to treat a subgroup of severe ED patients. These preliminary data need to be reconfirmed by multicenter sham control studies in a larger group of ED patients.
MeSH term(s)	Adult ; Aged ; Erectile Dysfunction/therapy ; Humans ; Male ; Middle Aged ; Penile Erection ; Penis/blood supply ; Penis/diagnostic imaging ; Treatment Outcome ; Ultrasonic Therapy/methods ; Ultrasonography
Language	English
Publishing date	2012-01
Publishing country	Netherlands
Document type	Clinical Trial ; Journal Article
ZDB-ID	2251959-2
ISSN	1743-6109 ; 1743-6095
ISSN (online)	1743-6109
ISSN	1743-6095
DOI	10.1111/j.1743-6109.2011.02498.x
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Article ; Online: Low Intensity Shock Wave Treatment for Erectile Dysfunction-How Long Does the Effect Last?

Kitrey, Noam D / Vardi, Yoram / Appel, Boaz / Shechter, Arik / Massarwi, Omar / Abu-Ghanem, Yasmin / Gruenwald, Ilan

The Journal of urology

2018 Volume 200, Issue 1, Page(s) 167–170

Abstract: Purpose: We studied the long-term efficacy of penile low intensity shock wave treatment 2 years after an initially successful outcome.: Materials and methods: Men with a successful outcome of low intensity shock wave treatment according to the ... ...

Abstract	Purpose: We studied the long-term efficacy of penile low intensity shock wave treatment 2 years after an initially successful outcome. Materials and methods: Men with a successful outcome of low intensity shock wave treatment according to the minimal clinically important difference on the IIEF-EF (International Index of Erectile Function-Erectile Function) questionnaire were followed at 6, 12, 18 and 24 months. Efficacy was assessed by the IIEF-EF. Failure during followup was defined as a decrease in the IIEF-EF below the minimal clinically important difference. Results: We screened a total of 156 patients who underwent the same treatment protocol but participated in different clinical studies. At 1 month treatment was successful in 99 patients (63.5%). During followup a gradual decrease in efficacy was observed. The beneficial effect was maintained after 2 years in only 53 of the 99 patients (53.5%) in whom success was initially achieved. Patients with severe erectile dysfunction were prone to earlier failure than those with nonsevere erectile dysfunction. During the 2-year followup the effect of low intensity shock wave treatment was lost in all patients with diabetes who had severe erectile dysfunction at baseline. On the other hand, patients with milder forms of erectile dysfunction without diabetes had a 76% chance that the beneficial effect of low intensity shock wave treatment would be preserved after 2 years. Conclusions: Low intensity shock wave treatment is effective in the short term but treatment efficacy was maintained after 2 years in only half of the patients. In patients with milder forms of erectile dysfunction the beneficial effect is more likely to be preserved.
MeSH term(s)	Aged ; Erectile Dysfunction/therapy ; Extracorporeal Shockwave Therapy ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Severity of Illness Index ; Time Factors ; Treatment Outcome
Language	English
Publishing date	2018-03-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	3176-8
ISSN	1527-3792 ; 0022-5347
ISSN (online)	1527-3792
ISSN	0022-5347
DOI	10.1016/j.juro.2018.02.070
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Article: Shockwave treatment of erectile dysfunction.

Gruenwald, Ilan / Appel, Boaz / Kitrey, Noam D / Vardi, Yoram

Therapeutic advances in urology

2013 Volume 5, Issue 2, Page(s) 95–99

Abstract: Low-intensity extracorporeal shock wave therapy (LI-ESWT) is a novel modality that has recently been developed for treating erectile dysfunction (ED). Unlike other current treatment options for ED, all of which are palliative in nature, LI-ESWT is unique ...

Abstract	Low-intensity extracorporeal shock wave therapy (LI-ESWT) is a novel modality that has recently been developed for treating erectile dysfunction (ED). Unlike other current treatment options for ED, all of which are palliative in nature, LI-ESWT is unique in that it aims to restore the erectile mechanism in order to enable natural or spontaneous erections. Results from basic science experiments have provided evidence that LI-ESWT induces cellular microtrauma, which in turn stimulates the release of angiogenic factors and the subsequent neovascularization of the treated tissue. Extracorporeal shock wave therapy (ESWT) has been clinically investigated and applied in several medical fields with various degrees of success. High-intensity shock wave therapy is used for lithotripsy because of its focused mechanical destructive nature, and medium-intensity shock waves have been shown to have anti-inflammatory properties and are used for treating a wide array of orthopedic conditions, such as non-union fractures, tendonitis, and bursitis. In contrast, LI-ESWT has angiogenetic properties and is therefore used in the management of chronic wounds, peripheral neuropathy, and in cardiac neovascularization. As a result of these characteristics we initiated a series of experiments evaluating the effect of LI-ESWT on the cavernosal tissue of patients with vasculogenic ED. The results of our studies, which also included a double-blind randomized control trial, confirm that LI-ESWT generates a significant clinical improvement of erectile function and a significant improvement in penile hemodynamics without any adverse effects. Although further extensive research is needed, LI-ESWT may create a new standard of care for men with vasculogenic ED.
Language	English
Publishing date	2013-03-11
Publishing country	England
Document type	Journal Article
ZDB-ID	2492591-3
ISSN	1756-2880 ; 1756-2872
ISSN (online)	1756-2880
ISSN	1756-2872
DOI	10.1177/1756287212470696
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Article ; Online: Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes.

Gruenwald, Ilan / Kitrey, Noam D / Appel, Boaz / Vardi, Yoram

Sexual medicine reviews

2013 Volume 1, Issue 2, Page(s) 83–90

Abstract: Introduction: Low-intensity extracorporeal shock wave therapy (LI-ESWT) to the penis has recently emerged as a new and promising modality in the treatment of erectile dysfunction (ED).: Aim: To review the published literature on the mechanism of ... ...

Abstract	Introduction: Low-intensity extracorporeal shock wave therapy (LI-ESWT) to the penis has recently emerged as a new and promising modality in the treatment of erectile dysfunction (ED). Aim: To review the published literature on the mechanism of action of LI-ESWT; and to report our clinical data on its efficacy in men with vasculogenic ED. Methods: A Medline search using the relevant keywords on this topic has been done. Results: From the results of numerous preclinical and animal studies that have been done to date, sufficient evidence shows that the underlying mechanism of action of LI-ESWT is probably neovascularization. Therefore, local application of LI-ESWT to the corpora cavernosa may potentially act in the same mechanism and increase corporal blood flow. We found that the application of LI-ESWT to patients who responded to oral therapy (PDE5i) eliminated their dependence on PDE5i and they were able to successfully achieve erections and vaginal penetration (60-75%). Furthermore, PDE5i non-responders became responders and capable of vaginal penetration (72%). Additionally, LI-ESWT resulted in long-term improvement of the erectile mechanism. Conclusions: LI-ESWT has the potential to improve and permanently restore erectile function by reinstating the penile blood flow. Although these results on LI-ESWT are promising, further multi- centered studies with longer follow-up are needed to confirm these findings. Gruenwald I, Kitrey ND, Appel B, and Vardi Y. Stem low-intensity extracorporeal shock wave therapy in vascular disease and erectile dysfunction: Theory and outcomes. Sex Med Rev 2013;1:83-90.
Language	English
Publishing date	2013-07
Publishing country	Netherlands
Document type	Review ; Journal Article
ZDB-ID	2722257-3
ISSN	2050-0521 ; 2050-0513
ISSN (online)	2050-0521
ISSN	2050-0513
DOI	10.1002/smrj.9
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Article ; Online: Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study.

Kitrey, Noam D / Gruenwald, Ilan / Appel, Boaz / Shechter, Arik / Massarwa, Omar / Vardi, Yoram

The Journal of urology

2015 Volume 195, Issue 5, Page(s) 1550–1555

Abstract: Purpose: We performed sham controlled evaluation of penile low intensity shock wave treatment effect in patients unable to achieve sexual intercourse using PDE5i (phosphodiesterase type 5 inhibitor).: Materials and methods: This prospective, ... ...

Abstract	Purpose: We performed sham controlled evaluation of penile low intensity shock wave treatment effect in patients unable to achieve sexual intercourse using PDE5i (phosphodiesterase type 5 inhibitor). Materials and methods: This prospective, randomized, double-blind, sham controlled study was done in patients with vasculogenic erectile dysfunction who stopped using PDE5i due to no efficacy. All patients had an erection hardness score of 2 or less with PDE5i. A total of 58 patients were randomized, including 37 treated with low intensity shock waves (12 sessions of 1,500 pulses of 0.09 mJ/mm(2) at 120 shock waves per minute) and 18 treated with a sham probe. In the sham group 16 patients underwent low intensity shock wave treatment 1 month after sham treatment. All patients were evaluated at baseline and 1 month after the end of treatment using validated erectile dysfunction questionnaires and the flow mediated dilatation technique for penile endothelial function. Erectile function was evaluated while patients were receiving PDE5i. Results: In the low intensity shock wave treatment group and the sham group 54.1% and 0% of patients, respectively, achieved erection hard enough for vaginal penetration, that is an EHS (Erection Hardness Score) of 3 (p <0.0001). According to changes in the IIEF-EF (International Index of Erectile Function-Erectile Function) score treatment was effective in 40.5% of men who received low intensity shock wave treatment but in none in the sham group (p = 0.001). Of patients treated with shock waves after sham treatment 56.3% achieved erection hard enough for penetration (p <0.005). Conclusions: Low intensity shock wave treatment is effective even in patients with severe erectile dysfunction who are PDE5i nonresponders. After treatment about half of them were able to achieve erection hard enough for penetration with PDE5i. Longer followup is needed to establish the place of low intensity shock wave treatment in these challenging cases.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Double-Blind Method ; Erectile Dysfunction/physiopathology ; Erectile Dysfunction/therapy ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Penile Erection/drug effects ; Penile Erection/physiology ; Penis/drug effects ; Penis/physiopathology ; Phosphodiesterase 5 Inhibitors/therapeutic use ; Prospective Studies ; Severity of Illness Index ; Surveys and Questionnaires ; Time Factors ; Treatment Outcome ; Ultrasonic Therapy/methods
Chemical Substances	Phosphodiesterase 5 Inhibitors
Language	English
Publishing date	2015-12-13
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	3176-8
ISSN	1527-3792 ; 0022-5347
ISSN (online)	1527-3792
ISSN	0022-5347
DOI	10.1016/j.juro.2015.12.049
Database	MEDical Literature Analysis and Retrieval System OnLINE

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