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Clinical Evidence

Definition of erectile dysfunction measurement for clinical trials:

Measurement of erectile dysfunction severity based on International Index of Erectile Function Questionnaire (IIEF).

Measurement of erectile dysfunction severity based on the Erection Hardness Score (EHS).

Success rate of patients undergoing Medispec Shock Wave Therapy by IIEF

 

 

Result from Internal Meta-Analysis

Success rate of patients undergoing Medispec Shock Wave Therapy by EHS

Total of 99 patients were included in this clinical trial with 22 patients from mild category, 39 from moderate category, and 38 patients from severe category. Prior to treatment, all patients had EHS < 3. After 12 sessions of treatment, a total of 85% patients from mild/ moderate category achieved EHS ≥ 3, and 50% in severe category achieved EHS ≥ 3.

Success rate achieved in patients who do not respond to PDE5-I (like Viagra)

Improvement has been shown among poor responders to PDE5i after undergoing Medispec shock wave therapy.

Gruenwald I, Appel B, Vardi Y. “Low-intensity extracorporeal shock wave therapy–a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy.” J Sex Med. 2012 Jan;9(1):259-64.

Randomized control trial results

The trial found a significantly greater increase in the IIEF score from visit 1 to follow-up 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 Medispec shock wave therapy, compared to none in the sham group.

Physiologically penile blood flow 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).

Y. Vardi, B. Appel, A. Kilchevsky,I. Gruenwald – “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.” THE JOURNAL OF UROLOGY Vol. 187, 1769-1775, May 2012

How long does the effect last?

Based on clinical studies, the effect of improvement can last at least for 2 years.

* Vardi, Y., B. Appel, et al. (2010). “Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction.” Eur Urol 58(2): 243-248.

** Vardi Y et al. “Low Energy Shockwaves for the Treatment of Erectile Dysfunction.” ESSM Congress 2011, Milan, Italy

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