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Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial

Eric Chung*and Ross Cartmill*

*Department of Urology, Princess Alexandra Hospital, University of Queensland, and St. Andrew’s Pelvic Medicine Centre, St Andrew’s War Memorial Hospital, Brisbane, Old, Australia


Objective

To evaluate the efficacy, safety and patient satisfaction rate with low-intensity extracorporeal shockwave therapy (LiESWT) in Australian men with erectile dysfunction (ED), as LiESWT induces neovascularisation and potentially enhances penile perfusion and improves erectile function.

Patients and Methods

Open-label single-arm prospective study of patients with ED with five-item version of the International Index of Erectile Function (IIEF-5) scores of >12 at baseline were enrolled after informed consent. Patient demographics, change in IIEF-5 and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, and overall satisfaction score (on a 5-point scale) were recorded. Treatment consists of 3000 shockwaves (1000 shockwaves to the distal penis, base of penis and corporal bodies at the perineum) twice weekly for 6 weeks.

Results

All patients had tried and failed oral phosphodiesterase type 5 inhibitors and most of the patients hah had ED for >18 months [mean (range) 21.8 (6–60) months]. No side-effects to LiESWT were reported.Most patients reported an improvement in IIEF-5 score by 5 points (60%) and EDITS Index score by >50% (70%).Most patients were satisfied (scoring 4 out of 5; 67%) and would recommend the therapy to their friends (80%).

Conclusion

LiESWT appears to improve erectile function, is safe and potential plays an important role in penile rehabilitation in men whom failed medical therapy.

Keywords

low-intensity extracorporeal shockwave therapy, erectile dysfunction, clinical outcomes, patient satisfaction, erectile function


Introduction

Erectile dysfunction (ED) is a common psychosexual condition affecting men across all ages and the current management strategies consist of a step-wise approach with modification of risk factors, optimisation of existing medical comorbidities followed by medical therapy, such as oral phosphodiesterase type 5 (PDE5) inhibitors and intracavernosal injection of vasoactive agents, with penile prosthesis implant reserved in the advanced stage [1]. While the efficacy of medical therapy is relatively high and the drugs are generally safe with minimal adverse effects, they treat the symptom of ED only and do not alter the underlying pathophysiology of the disease process.

The concept of penile rehabilitation is based on the premise that such therapy will eventually restore the erectile mechanism and allow men to regain spontaneous erection. Recent reports have indicated that low-intensity extracorporeal shockwave therapy (LiESWT) to the corpora cavernosa could play a role in penile rehabilitation [2,3]. Animal studies showed that LiESWT significantly improves penile haemodynamics and restores pathological changes in the penis of diabetic ED rat models [4,5]. Furthermore, LiESWT induces cellular microtrauma, and promotes angiogenesis by enhancing the expression of vascular endothelial growth factor [6,7] and recruitment of endothelial progenitor cells [8].

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