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Sramkova T. et al., 2019: Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial

Sramkova T, Motil I, Jarkovsky J, Sramkova K.
Department of Sexology, University Hospital and Department of Traumatology, Masaryk University, Brno, Czechia.
Department of Urology First Faculty of Medicine, Charles University Prague and General University Hospital, Prague, Czechia.
EURED Urology, Andrology Center, Brno, Czechia.
Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czechia.
Department of Urology, St. Anna Hospital, Brno, Czechia.

Abstract

INTRODUCTION:
Low-intensity extracorporeal shock wave therapy (Li-ESWT) is a new treatment modality for erectile dysfunction (ED). Our aim was to evaluate the treatment outcome of Li-ESWT for ED in single-blind, placebo controlled, randomized clinical trial.

METHODS:
Sixty patients were randomized into 2 age-matched groups: Group A - treatment and Group B - placebo. Treatment consisted of 4 sessions on the PiezoWave2 unit (R. Wolf and ELvation Medical). Effectiveness was assessed according to the International Index of Erectile Function 5 (IIEF-5), Erectile Hardness Score (EHS), questions 2 and 3 of the Sexual Encounter Profile (SEP 2, SEP 3), and Global Assessment Question (GAQ) scores at baseline and 4 and 12 weeks after treatment. We evaluated patient's and partner's subjective satisfaction.

RESULTS:
A statistically significant difference between the groups was found at 4 and 12 weeks after treatment with regard to the quality of erection as measured by the IIEF-5 (p = 0.049 and p < 0.001, respectively), the EHS after week 12 (p < 0.001), an increase in the EHS after 4 and 12 weeks (p = 0.030 and p < 0.001, respectively), after 12 weeks in GAQ (p < 0.001), SEP 2 (p = 0.05), SEP 3 (p < 0.001), and patient's satisfaction (p < 0.001) and partner's satisfaction (p < 0.001).

CONCLUSIONS:
The randomized single-blind study confirms that Li-ESWT significantly improves erectile function.

Urol Int. 2019 Dec 11:1-8. doi: 10.1159/000504788. [Epub ahead of print]

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Comments 1

Peter Alken on Tuesday, February 18 2020 08:30

Reading this paper I had from the very start - even before getting to the methods section - the feeling that it will surely show a positive result. I do not remember to have read better outcomes of this kind of treatment.

The authors state “According to the European Association of Urologyguidelines, Li-ESWT the first line of ED treatment.“
In the EAU guidelines the therapy of ED is classified according to its invasiveness.
First line treatments are:
1. Phosphodiesterase-5-inhibitors,
2. Topical/intraurethral alprostadil
3. Vacuum device
4. Low intensity shock wave treatment
Intracorporeal injections and penile prosthesis are classified as second and third line procedures.
It is only because of the non-invasiveness that shockwave treatment is listed among the first line treatment and not because of its proven effectivity; the guideline states:
“However, the publication of unequivocal evidence from additional RCTs and longer-term follow-up would provide more confidence regarding the use of LI-SWT (including detailed number of pulses per patient, treatment protocols) for ED patients. Therefore clear and definitive recommendations cannot be given.”

If other groups will be able to duplicate the results of this study the position of LI-SWT within the guidelines may change.

Reading this paper I had from the very start - even before getting to the methods section - the feeling that it will surely show a positive result. I do not remember to have read better outcomes of this kind of treatment. The authors state “According to the European Association of Urologyguidelines, Li-ESWT the first line of ED treatment.“ In the EAU guidelines the therapy of ED is classified according to its invasiveness. First line treatments are: 1. Phosphodiesterase-5-inhibitors, 2. Topical/intraurethral alprostadil 3. Vacuum device 4. Low intensity shock wave treatment Intracorporeal injections and penile prosthesis are classified as second and third line procedures. It is only because of the non-invasiveness that shockwave treatment is listed among the first line treatment and not because of its proven effectivity; the guideline states: “However, the publication of unequivocal evidence from additional RCTs and longer-term follow-up would provide more confidence regarding the use of LI-SWT (including detailed number of pulses per patient, treatment protocols) for ED patients. Therefore clear and definitive recommendations cannot be given.” If other groups will be able to duplicate the results of this study the position of LI-SWT within the guidelines may change.
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