1 Urology Journal Clubs Extracorporeal Shock Wave in

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Urology Journal Clubs Extracorporeal Shock Wave in Treatment of Erectile Dysfunction & Peyronie's disease : Yes or No? Alireza Ghoreifi, MD, FEBU Assistant Professor of Urology, MUMS

Eur Urol. 2017 Feb; 71(2): 223 -233 doi: 10. 1016/j. eururo. 2016. 050. Epub 2016 Jun 16 (IF: 14. 976)

World J Urol. 2017 Jan; 35(1): 1 -9 doi: 10. 1007/s 00345 -016 -1834 -2. Epub 2016 Apr 23 (IF: 2. 397)

Extracorporeal Shock Wave Therapy and Erectile Dysfunction

Int J Urol. 2016 Jan; 23(1): 80 -4. doi: 10. 1111/iju. 12955. Epub 2015 Oct 26.

Methods • The present study included 57 patients with erectile dysfunction who satisfied all the following conditions: Ø more than 6 -months history of erectile dysfunction Ø sexual health inventory for men score of ≤ 12 without phosphodiesterase type-5 inhibitor Ø erection hardness score grade 1 or 2 Ø mean penile circumferential change by erectometer assessing sleep related erection of <25 mm Ø non-neurological pathology

• Patients were treated by a low-energy shock waves generator (ED 1000, Medispec, Gaithersburg, MD, USA). • LI-SWT was applied on five penile sites – three sites on the penile shaft and on both crura – with 300 shock waves (0. 09 m. J/ mm 2) for 3 min each (a frequency of 120 shocks/min). • Treatment was delivered on only one side of the penile shaft, as shock wave depth reached both corpora. • The 9 -week treatment period was divided into three 3 -week periods. We carried out LI-SWT twice-weekly during the first and third periods, with no treatment during the interim 3 week period.

• Sexual health inventory for men score, erection hardness score with or without phosphodiesterase type-5 inhibitor, and mean penile circumferential change were assessed at baseline, 1, 3 and 6 months after the termination of low-intensity shock wave therapy.

Results • Of 57 patients who were assigned for the low-intensity shock wave therapy trial, 56 patients were analyzed. • Patients had a median age of 64 years. • The sexual health inventory for men and erection hardness score (with and without phosphodiesterase type-5 inhibitor) were significantly increased (P < 0. 001) at each time point. • The mean penile circumferential change was also increased from 13. 1 to 20. 2 mm after low-intensity shock wave therapy (P < 0. 001). • In the multivariate analysis, age and the number of concomitant comorbidities were statistically significant predictors for the efficacy.

Conclusions • Low-intensity shock wave therapy seems to be an effective physical therapy for erectile dysfunction. • Age and co-morbidities are negative predictive factors of therapeutic response.

J Sex Med. 2017 Jan; 14(1): 106 -112. doi: 10. 1016/j. jsxm. 2016. 11. 307. Epub 2016 Dec 6.

Methods • Men with ED (n = 126) and a score lower than 25 points on the International Index of Erectile Function erectile function domain (IIEF-EF) were included. • Subjects were allocated to receive LLi-ESWT once a week for 5 weeks or sham treatment once a week for 5 weeks. After a 4 -week break, the two groups received active treatment once a week for 5 weeks. • Subjects completed the IIEF, Erection Hardness Scale (EHS), Sexual Quality of Life-Men, and the Erectile Dysfunction Inventory of Treatment Satisfaction at baseline, after 9 weeks, and after 18 weeks.

Main Outcome Measures • The primary outcome measurement was an increase of at least five points on the IIEF-EF score. • • The secondary outcome measurement was an increased EHS score to at least 3 in men with a score no higher than 2 at baseline. • Data were analyzed by linear and logistic regression.

Results • Mean IIEF-EF scores were 11. 5 at baseline, 13. 0 after five sessions, and 12. 6 after 10 sessions in the sham group and correspondingly 10. 9, 13. 1, and 11. 8 in the ESWT group. • Success rates based on IIEF-EF score were 38. 3% in the sham group and 37. 9% in the ESWT group (odds ratio = 0. 95) • Success rates based on EHS score were 6. 7% in the sham group and 3. 5% in the ESWT group (odds ratio = 0. 44)

Conclusion • No clinically relevant effect of LLi-ESWT on ED was found.

J Urol. 2016 Sep; 196(3): 950 -6. doi: 10. 1016/j. juro. 2016. 03. 147. Epub 2016 Mar 30.

Conclusions • Low intensity extracorporeal shock wave therapy improved erectile function in GK rats. • Unexpectedly, this was not mediated by a nitric oxide/cyclic guanosine monophosphate dependent mechanism. • Sildenafil increased shock wave efficacy.

Eur Urol. 2017 Feb; 71(2): 223 -233 doi: 10. 1016/j. eururo. 2016. 050. Epub 2016 Jun 16 (IF: 14. 976)

• • • The search terms were shock wave AND (erectile OR IIEF OR EHS). Forty-eight records were enrolled. After review, 14 studies about lowintensity extracorporeal shock wave treatment and erectile dysfunction were included. Seven were randomized controlled trials and were included in the metaanalysis. ED = erectile dysfunction; EHS = Erection Hardness Score; IIEF = International Index of Erectile Function; LI-ESWT = low-intensity extracorporeal shock wave treatment; RCT = randomized controlled trial.

Current studies of low-intensity extracorporeal shock wave treatment for erectile dysfunction patients

Evidence synthesis • There were 14 studies including 833 patients from 2005 to 2015. • Seven studies were randomized controlled trials (RCTs); however, in these studies, the setup parameters of LI-ESWT and the protocols of treatment were variable. • The meta-analysis revealed that LI-ESWT could significantly improve IIEF (p < 0. 0001) and EHS (p = 0. 01). • Therapeutic efficacy could last at least 3 mo. • The patients with mild and moderate ED had better therapeutic efficacy after treatment than patients with more severe ED or comorbidities. • Energy flux density, number of shock waves per treatment, and duration of LI-ESWT treatment were closely related to clinical outcome, especially regarding IIEF improvement.

Conclusion • The number of studies of LI-ESWT for ED have increased dramatically in recent years. • Most of these studies presented encouraging results, regardless of variation in LI-ESWT setup parameters or treatment protocols. • These studies suggest that LI-ESWT could significantly improve the IIEF and EHS of ED patients. • The publication of robust evidence from additional RCTs and longer-term follow-up would provide more confidence regarding use of LI-ESWT for ED patients.

EAU Guideline 2016

Extracorporeal Shock Wave Therapy and Peyronie's disease

World J Urol. 2017 Jan; 35(1): 1 -9 doi: 10. 1007/s 00345 -016 -1834 -2. Epub 2016 Apr 23 (IF: 2. 397)

Characteristics of studies of ESWT for PD • Three of 15 studies on treatment of PD with ESWT were selected according to inclusion criteria. • Studies included 238 patients.

Summary of basic characteristics and results— Peyronie’s disease studies

Results of individual studies on PD • Hatzichristodoulou et al. Ø showed no statistically significant beneficial effects on sexual function (non-standardized questionnaire) and plaque size. Ø Furthermore, authors were concerned for an increase in penile deviation in the treated group, due to the fact that plaque size increased in five individuals in the ESWT group only. Ø A positive effect on pain using a VAS scale was reported. • Chitale et al. Ø did not observe any positive changes in pain, International Index of Erectile Function (IIEF) and curvature after therapy. Ø On the contrary, mean dorsal and lateral angle deterioration was observed in the ESWT group compared to a moderate improvement in the sham group. • Palmieri et al. Ø found at 12 weeks post-treatment that mean pain VAS score, IIEF and mean quality of life score (Qo. L) were significantly improved in the active-treated group. Ø At 24 weeks, mean plaque size and curvature were significantly higher in the sham-treated group when compared to both baseline and ESWT values.

Conclusions • ESWT may resolve pain in PD patients, while evidence for reducing curvature and plaques size is poor.

Campbell, 2016 (Chapter: 31, P: 737)

EAU Guideline 2016 • Extracorporeal shock-wave treatment does not improve penile curvature and plaque size, but it may be offered for penile pain. (LE 2 b) • Do not use extracorporeal shock-wave treatment to improve penile curvature and plaque size. (LE: 1 b, GR: C)