Low Energy Shockwaves for the Treatment of Erectile Dysfunction Y. Vardi, B. Appel, I Gruenwald

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1 Low Energy Shockwaves for the Treatment of Erectile Dysfunction Y. Vardi, B. Appel, I Gruenwald Neuro-Urology Unit, Rambam Medical Center & the Technion Faculty of Medicine Haifa, Israel

2 3 crucial questions 1. Does it work? 2. Is it better than placebo? 3. Is there any effect in PDE5i NON-responders?

3 Does it work?

4 Pilot Study 20 patients with diabetes and/or cardiovascular history Mean age 56.1±10.7y, IIEF-ED domain scores between 5-19 (average 13.5) and abnormal NPT parameters All responsive to PDE5I. Agree to stop PDE5i treatment during all study protocol

5 Pilot Study Design Baseline assessment Without PDE5i Visit 1: Evaluation with IIEF, QEQ, RS, SEARS, NPT, FMD. Follow-up assessment Without PDE5i F.U 1: Evaluation with IIEF, QEQ, RS, SEARS, EDITS, NPT FMD. 1m Wash out 3 w Treatment X2/w (Total =6) Mid term Evaluation 3 w no treatment 3 w Treatment X2/w (Total =6) End term Evaluation 1m no treatment F.U 2: 3m Evaluation IIEF-ED Domain F.U 3: 6m 52 weeks

6 Results Test Baseline Mean SD 1 month F.U. Mean SD % p IIEF ED Domain IIEF Total % 37% <0.001 QEQ % <0.001 Rigid Score % <0.001 SEARQ % <0.001 No pain or any other side effects were noted nor reported

7 Results: IIEF ED Domain Change from baseline 5 subjects did not respond to the treatment protocol In 15 patients improvement of >5 points 7 of them more than10 points. 10 patients stopped PDE5 I Treatment, 5 use it occasionally, (6 month 9 and FU)

8 Changes in NPT parameters Parameter Baseline (sd) 1-Month after treatment (sd) (%) patients improved Total number of erections 3.9 ± ± % Total erection time (h) 1.3 ± ± % Average tip rigidity 37.2 ± ± % Average base rigidity 47.5 ± ± % Max rigidity best event - tip 52.6 ± ± % Max rigidity best event - base 66.9 ± ± % Max time - best event 29.7± ± %

9 Flow (ml/min/dl) Endothelial Function Tests FMD (Flow Mediated Dilation) Forearm p = NS Penis p < Baseline flow Maximal flow Baseline flow Maximal flow Baseline 1 month F.U.

10 Correlations between FMD indices to the changes in IIEF-ED at one-month Strong positive correlation between IIEF-ED and FMD

11 Maximal penile blood flow using FMD Pre treatment Post treatment

12 Is it better than placebo?

13 Patient screening and randomization 2/3 receive treatment and 1/3 receive sham

14 Study flow chart.

15 Baseline characteristic of patients population at baseline while off PDE5i

16 Treatment blindness

17 IIEF ED Domain scores before and after treatment in both groups IIEF-ED Domain score Post Treatment Baseline NS P<0, Placebo Treated 0

18 Treatment Success (IIEF) 65% IIEF-ED Domain scores 5 points at FU1 (without PDE5i) Number of patients N=26 25% N=5 P= Treated (n=40) Placebo (n=20)

19 Success according to erection hardness score (EHS) of 3

20 Changes in the IIEF category scores Full IIEF * Overall Overall Satisfaction Satisfaction * Sexual Desire Sexual Desire Orgasmic Function Orgasmic Function Intercourse Satisfaction Intercourse IIEF ED Satisfaction IIEF-ED Domain * * p<0.005

21 Changes in penile blood flow

22 Is there any effect in PDE5i NON-responders?

23 Patients 33 non responders men entered the study 4 Discontinued due to: Physician decision (n=2), Subject decision (n=1), Protocol violation (n=1). 29 (90.9%) completed 12 weeks treatment Main inclusion criteria: Rigidity score 2 during PDE5i therapy

24 Study Chart Baseline assessment Follow-up assessment Screening Evaluation With PDE5i F.U 1: Evaluation without PDE5i F.U 2: Evaluation With PDE5i Mid term Evaluation End term Evaluation 3 w Treatment X2/w (Total =6) 3 w no treatment 3 w Treatment X2/w (Total =6) 1m no treatment 1m Active PDE5i treatment weeks (3 months)

25 Non-responders: Results J Sex Med Oct 18. [Epub ahead of print] With PDE5i With PDE5i For 22 patients (75.9%) IIEF ED Domain scores changed by 5 points or more once resuming PDE5-I

26 Changes in Rigidity Scales according to visit Rigidity Scores p<0.001 J Sex Med Oct 18. [Epub ahead of print]

27 Data Drawn from 3 Studies n=124 LI-ESWT on Responders, pilot (N=20) LI-ESWT on non-responders, pilot (N=29) LI-ESWT on Responders, double-blind sham controlled (N=75) Baseline Characteristics Age, mean (years) 58.8 Duration of ED, mean (months) 58.2 IIEF-EF at baseline, mean 11.2

28 Defining Success

29 Percentage of men with a minimal clinical IIEF-EF Improvement Improvement in IIEF-EF (% men) 61 N=10 *Treatment endpoint for responders was without PDE5-i and for non-responders with PDE5-i

30 Mean Change of IIEF-EF from Baseline to Endpoint* by Age Mean Improvement in IIEF-EF 6.9 *Treatment endpoint for responders was FU1 without PDE5-i and for non-responders was FU2 with PDE5-i

31 Percentage of men with a minimal clinical IIEF-EF Improvement Diabetic Patients* Improvement in IIEF-EF (% men) 56** N=10 *Mean HbA1c was 8.4% **56% of diabetic men reported improvement in ED with oral sildenafil based on IIEF (Rendell, JAMA 1999) ***Treatment endpoint for responders was FU1 without PDE5-i and for non-responders was FU2 with PDE5-i

32 Percentage of Patients Normalized* at Endpoint** Percent Normal at Endpoint 21 *Normalization defined as an IIEF 25 **Treatment endpoint for responders was FU1 without PDE5-i and for non-responders was FU2 with PDE5-i

33 Ongoing Trials Sham-controlled for non-responders European Multi-center study Other treatment protocols

34 Conclusions The first non-invasive method that has the potential to improve or even cure in some patients the erectile mechanism Able to replace oral treatment in patients who previously responded to PDE5i Able to reverse PDE5i non-responders to responders

35

36 Efficacy of LI-ESWT Relative to PDE5-i Mean Improvement in IIEF-EF ED severity Brock, et al. J of U, Donatucci, et al. JSM, 2004.

37 Mean Change of IIEF-EF from Baseline to Endpoint by Age Mean Improvement in IIEF-EF Age Carson, et al. BJU, 2004.

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