Ladegaard PBJ. et al., 2021: Erectile Dysfunction A Prospective Randomized Placebo-Controlled Study Evaluating the Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) in Men With Erectile Dysfunction Following Radical Prostatectomy.
Ladegaard PBJ, Mortensen J, Skov-Jeppesen SM, Lund L.
Department of Urology, Odense University Hospital, Odense, Denmark.
Abstract
Introduction: Previous studies have indicated that low-intensity extracorporeal shockwave therapy (Li-ESWT) may improve male erectile dysfunction (ED) of vascular aetiology.
Aim: To investigate penile rehabilitation of Li-ESWT in a randomized, placebo-controlled trial in men with ED following robotic nerve-sparing radical prostatectomy (RARP).
Methods: Included were men with ED following nerve-sparing RP with a score <22 in the 5-item International Index of Erectile Function (IIEF-5) questionnaire. Participants were divided into an active A (n = 20) and a placebo/sham B group (n = 18). They were randomized consecutively upon study entry. Each study arm had one treatment a week for 5 weeks.
Main outcome measures: Sexual outcomes were assessed by international validated questionnaires, Erection Hardness Score (EHS) and IIEF-5 at baseline and at 4 and 12 weeks after treatment.
Results: A total of 38 (n = 38) participants were enrolled; there were no dropouts. A significant increase was observed in IIEF-5 and EHS in group A at both 4 and 12 weeks. At 12 weeks, the mean IIEF-5 score had increased by 3.45 points (P = .026), while the mean EHS score had increased by 0.5 points (P= .019).
Conclusion: This randomized study indicates that Li-ESWT for ED in men undergone RP might be effective and safe. However, further and more robust research is needed before Li-ESWT can be characterized as a reliable treatment modality.
Sex Med. 2021 Mar 28;9(3):100338. doi: 10.1016/j.esxm.2021.100338. Online ahead of print. PMID: 33789173. FREE ARTICLE
Comments 1
The paper is published in Sexual Medicine, an official publication of the International Society for Sexual Medicine. The journal publishes 1 volume a year. The impact factor is 2,491, rising. The open access publishing charge is 2500$ and 500$ for society members.
I enjoyed reading the present paper, because it has a very neutral touch in reporting about this study, well reflected in the discussion: “The mean IIEF-5 and EHS scores increased significantly, but only by few points, doubtful to give a meaningful sexual effect. We therefore question whether Li-ESWT has a major role to play in the treatment of ED in men following RARP. We found Li-ESWT to be safe. However, future research in Li-ESWT following RP should focus on initial timing of treatment, stratification of ED subgroups most susceptible to treatment, the efficiency of Li-ESWT in combination with other treatment modalities (eg, 5-PDEi or stem cell therapy) and defining the most optimal time for shockwave application. However, we aim to get a more accurate answer after our current initiated prospective randomized study where 70 men receive treatment 3 weeks after RARP.”
In other publications on this topic, there is frequently an enthusiasm combined with an overzealous positive interpretation of the results. I recommend reading this paper to those interested in the topic.
Peter Alken