Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study

Eric Chung; Ross Cartmill

doi:10.1016/j.esxm.2021.100384

Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study

Sex Med. 2021 Aug;9(4):100384. doi: 10.1016/j.esxm.2021.100384. Epub 2021 Jun 11.

Authors

Eric Chung¹, Ross Cartmill²

Affiliations

¹ The University of Queensland, Department of Urology, Princess Alexandra Hospital, Brisbane, QLD, Australia; AndroUrology Centre, Brisbane, QLD, Australia; AndroUrology Centre, Sydney, NSW, Australia. Electronic address: ericchg@hotmail.com.
² The University of Queensland, Department of Urology, Princess Alexandra Hospital, Brisbane, QLD, Australia.

Abstract

Introduction: Low intensity extracorporeal shock wave therapy (LIESWT) improves erectile function (EF) in men with vascular erectile dysfunction (ED) but longer-term outcomes remain unknown.

Aim: To evaluate the clinical outcomes of LIESWT at a minimum 5-year follow-up.

Methods: This is an open-label single-arm prospective study involved men with vascular ED who received LIESWT.

Main outcome measure: Changes in patient demographics, IIEF-5 and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, as well as overall satisfaction score (on a 5-point scale) were reviewed at 12, 24, 48, and 60 months after completion of LIESWT. A chi-square contingency analysis was used to examine the relationship between erectile function score and treatment satisfaction, with statistical significance set at 5%.

Results: The mean follow-up period was 69.9 (63-82; median 76) months. The mean IIEF-5 scores for pretreatment and after treatment at 12, 24, 48, and 60 months were 14.8, 17.6, 16.8, 16.5, and 16.5 while the percentages of patients who reported an improvement in IIEF-5 score by 5 points were 60%, 45%, 40%, and 40%; and EDITS scores >50% were recorded in 70%, 55%, 50%, and 48% of patients at 12, 24, 48, and 60 months post-LIESWT. Ten patients required medical therapy and 2 patients opted for penile prosthesis implantation. The overall satisfaction rate appeared sustained subsequent follow-up (score 4 out of 5; 68% vs 50% vs 40% vs 40% at 12, 24, 48, and 60 months). There were minor time-limited, but no significant adverse event reported.

Conclusion: This long-term study showed the observed clinical improvement in EF continues to deteriorate but appears to plateau at 40% clinical efficacy at 48-60 months after completion of LIESWT. The absence of penile pain and deformity at 5-year follow-up supports the long-term safety data of LIESWT in men with ED. Chung E, Cartmill R. Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study. Sex Med 2021;9:100384.

Keywords: Clinical Outcomes; Erectile Dysfunction; Erectile Function; Long-Term Data; Low Intensity Extracorporeal Shock Wave Therapy; Patient Satisfaction.