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Fojecki GL et al, 2017: Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study.

Fojecki GL, Tiessen S, Sloth Osther PJ.
Department of Urology, Hospital of Southern Jutland, Sønderborg, Denmark.
Department of Urology, Odense University Hospital, Odense, Denmark.
Urological Research Center, Department of Urology, Lillebaelt Hospital, University of Southern, Denmark.

Abstract

INTRODUCTION: Short-term data on the effect of low-intensity extracorporeal shockwave therapy (Li-ESWT) on erectile dysfunction (ED) have been inconsistent. The suggested mechanisms of action of Li-ESWT on ED include stimulation of cell proliferation, tissue regeneration, and angiogenesis, which can be processes with a long generation time. Therefore, long-term data on the effect of Li-ESWT on ED are strongly warranted.
AIM: To assess the outcome at 6 and 12 months of linear Li-ESWT on ED from a previously published randomized, double-blinded, sham-controlled trial.
METHODS: Subjects with ED (N = 126) who scored lower than 25 points in the erectile function domain of the International Index of Erectile Function (IIEF-EF) were eligible for the study. They were allocated to 1 of 2 groups: 5 weekly sessions of sham treatment (group A) or linear Li-ESWT (group B). After a 4-week break, the 2 groups received active treatment once a week for 5 weeks. At baseline and 6 and 12 months, subjects were evaluated by the IIEF-EF, the Erectile Hardness Scale (EHS), and the Sexual Quality of Life in Men.
MAIN OUTCOME MEASURES: The primary outcome measure was an increase of at least 5 points in the IIEF-EF (ΔIIEF-EF score). The secondary outcome measure was an increase in the EHS score to at least 3 in men with a score no higher than 2 at baseline. Data were analyzed by linear and logistic regressions.
RESULTS: Linear regression of the ΔIIEF-EF score from baseline to 12 months included 95 patients (dropout rate = 25%). Adjusted for the IIEF-EF score at baseline, the difference between groups B and A was -1.30 (95% CI = -4.37 to 1.77, P = .4). The success rate based on the main outcome parameter (ΔIIEF-EF score ≥ 5) was 54% in group A vs 47% in group B (odds ratio = 0.67, P = .28). Improvement based on changes in the EHS score in groups A and B was 34% and 24%, respectively (odds ratio = 0.47, P = .82).
CONCLUSION: Exposure to 2 cycles of linear Li-ESWT for ED is not superior to 1 cycle at 6- and 12-month follow-ups. Fojecki GL, Tiessen S, Osther PJS. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study. Sex Med 2017;X:XXX-XXX.

Sex Med. 2017 Dec 21. pii: S2050-1161(17)30081-8. doi: 10.1016/j.esxm.2017.09.002. [Epub ahead of print]. FREE ARTICLE

 

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Comments 1

Peter Alken on Wednesday, 25 April 2018 13:02

A solid study on a swaying subject. The interested reader should have a look at:
Fode M, Hatzichristodoulou G, Serefoglu EC, Verze P, Albersen M, Young Academic Urologists Men's Health Group. Low-intensity shockwave therapy for erectile dysfunction: is the evidence strong enough? Nat Rev Urol. 2017 Oct;14(10):593-606
and
Man L, Li G. Low-Intensity Extracorporeal Shock Wave Therapy for Erectile Dysfunction: a Systematic Review and Meta-Analysis. Urology. 2017 Sep 26.

A solid study on a swaying subject. The interested reader should have a look at: Fode M, Hatzichristodoulou G, Serefoglu EC, Verze P, Albersen M, Young Academic Urologists Men's Health Group. Low-intensity shockwave therapy for erectile dysfunction: is the evidence strong enough? Nat Rev Urol. 2017 Oct;14(10):593-606 and Man L, Li G. Low-Intensity Extracorporeal Shock Wave Therapy for Erectile Dysfunction: a Systematic Review and Meta-Analysis. Urology. 2017 Sep 26.
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