EFFICACY AND SAFETY OF LOW-INTENSITY EXTRACORPOREAL SHOCKWAVE THERAPY FOR TREATMENT OF VASCULAR ERECTILE DYSFUNCTION IN NIGERIAN MEN: REPORT OF A STUDY IN IBADAN, SOUTH-WEST NIGERIA.


T.O. Akande1 , O.M. Akinwunmi2 , S.A. Adebayo3 , A.O. Akinyinka2 , and O.B. Shittu3

  1. Department of Medicine, University College Hospital, Ibadan, Nigeria. 
  2. Department of Radiology, College of Medicine, University of Ibadan, Ibadan, Nigeria. 
  3. Department of Surgery, College of Medicine, University of Ibadan, Ibadan, Nigeria.

Abstract

Background: Low Intensity Extracorporeal Shock Wave Therapy (LI-SWT) has been found to be effective in men with vascular erectile dysfunction (ED) but its efficacy and safety has not been investigated in a predominantly black population so we sought to study this. 

Materials and Methods: Men with vascular erectile dysfunction (ED) were assessed using the five-item International Index of Erectile Function (IIEF) score after which they were treated with 12 sessions of LI-SWT. Treatment efficacy was evaluated immediately after treatment, at 1 month and 6 months after using the IIEF questionnaire. 30 persons were recruited out of which 22 completed the study. 

Results: Mean IIEF score improved from 8.27+2.741 at baseline (pre-treatment) to 10.43 ± 8.43 one month post treatment and was sustained six months post treatment at mean IIEF score of 10.70 + 8.84. A larger no (86.4%) had an improvement of at least 5 in the IIEF score from baseline to 6 months -post treatment. None of the participants reported any adverse effects of treatment. 

Conclusion: Low intensity shock wave treatment is a useful addition to the medical armamentarium for the treatment of vascular ED.

Keywords: Erectile dysfunction, Efficacy, Extracorporeal shockwave therapy, Nigeria.

Correspondence:

Dr. T.O. Akande 

Department of Medicine, 

University College Hospital, 

Ibadan, Oyo State, 

Nigeria 

E mail: fumkande@yahoo.com

Introduction

Erection is a complex process involving several system interactions. Blood increment to cavernous tissues necessary for a rigid erection is huge and even small hemodynamic disturbances could produce sexual dysfunction.1

Erectile Dysfunction (ED), a common disorder affecting men, is defined as the inability to achieve and maintain erection adequate for satisfactory sexual intercourse. Erectile dysfunction (ED) is a common problem in persons with diabetes.2 The prevalence of ED in men with Type 2 diabetes mellitus (DM) varies from 35-90% , a proportion that is higher in patients with DM when compared to the general population.3 The prevalence of ED amongst Nigerian men with Type 2 DM is reported to range from 34-74%.4

Many studies have reported that erectile dysfunction is much more common in men with hypertension compared to those without hypertension. Reasons for this include penile circulatory disability due to atherosclerosis5 and antihypertensive drugs, especially some diuretics, beta blockers and methyldopa. These could all have a negative effect on erectile function.6 In a study in South-West Nigeria, prevalence of ED was higher in hypertensives compared to normotensives7 . Phosphodiestaerase 5 inhibitors (PDE5-I) are available and efficacious in treating erectile dysfunction but do not produce satisfactory results in a significant number of men.8

In addition, their effect and use is still related to and limited to the sexual act and is not curative.

Erectile dysfunction occurring in persons with diabetes is less responsive to PDE5-I. A study in persons with diabetes showed that less than 50% responded to PDE5-I. The effects of PDE 5-I on ED is shortterm. Before the advent of extracorporeal shock wave therapy, invasive treatments, like vacuum devices, intracavernous injections and use of penile prostheses were the second or third line of treatment for patients with poor response or with contraindication to PDE5- I.

Low intensity Extracorporeal Shock Wave Therapy (LI-SWT) is an innovative approach to vasculogenic ED, using a device that uses advanced acoustics technology. The mechanism underlying the efficacy of shock wave treatment is vasodilation and angiogenesis leading to improved blood flow to the penis. It has been postulated to cause cell membrane microtrauma and mechanical stress. This results in the release of angiogenic factors,such as vascular endothelial growth factor (VEGF),nitric oxide synthase (NOS), von Willebrand factor (vWF), fibroblast growth factor (FGF), TLR3, and the pro-inflammatory cytokines IL6 and IL-10, result in increased angiogenesis and vascularization of target tissues9

This technology has proven to be effective in persons with ischemic heart disease and vascular ED, LI-SWT utilizes low-intensity extracorporeal shock waves, focusing on blood vessels and encouraging neovascularization in the penile shaft and crus. The low-intensity shock waves help relieve vascular deficiency, a common cause of erectile dysfunction. Advantages of this therapy are its non-invasiveness, and no requirement for sedation or anaesthesia, hence can be done on outpatient basis. Others include absence of adverse and systemic effects, pain-free and lacking requirement for use of pharmaceuticals10 .

Discernible improvement in the erectile function of the penis can be visible within two weeks after therapy begins. Recent clinical studies also revealed that patients reported a high rate of satisfaction for more than two years after treatment, without need for the use of PDE5 inhibitors.11 Clinically, LI-SWT has shown significant long-term effectiveness. It has also been shown to be a safe therapy for ED.

The goal of this study is to assess the efficacy and safety of EDSWT in men with vascular ED in a predominantly black African population.