Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study

Sexual Medicine - Tập 6 Số 1 - Trang 1-7 - 2018
Grzegorz Fojecki1,2, Stefan Tiessen3,4, Palle Jörn Sloth Osther5,6,7,8
1Department of Urology   , Sønderborg , Denmark
2Hospital of Southern Jutland   , Sønderborg , Denmark
3Department of Urology   , Odense , Denmark
4Odense University Hospital, Odense, Denmark
5Department of Urology       , , Denmark
6Lillebælt Hospital, Denmark
7 University of Southern Denmark
8Urological Research Center       , , Denmark

Tóm tắt

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.

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Sexual Medicine

Tập 6 Số 1

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