Low Intensity Linear Focused Shockwave Therapy: a New Treatment to Improve the Quality of Life of Vascular Erectile Dysfunction Patients
Erectile dysfunction is a common medical disorder that primarily affects men older than 40 years of age . Phosphodiesterase type 5 inhibitors (PDE5i) are considered as first-line therapy as they increase arterial blood flow leading to smooth muscle relaxation, vasodilatation and penile erection . The limitation in the efficacy of PDE5 inhibitors is that a 'critical amount' of NO is necessary for these drugs to work. Therefore, in cases of impairment in NO synthesize or release or in cases of destruction of NO, PDE5 inhibitors cannot cure erectile dysfunction (ED) symptoms .
The correlation between potency and quality of life was established by a study on 1680 men seeking medical attention in a free screening program at three different locations in the USA. Unsurprisingly, it was reported that potent men have a better quality of life than impotent men .
Lately, studies have started to evaluate the effect of low intensity shockwave (LISW) to treat ED on PDE5i responders and non-responders patients [5-7].
The current study evaluated how the therapy by a new device ('RENOVA', Initia Ltd, Israel) using low-intensity linear focused shockwave affects the quality of life of patients who suffer from ED of vascular origin and experience full, partial or no response at all to PDE5 inhibitors.
Methods and results
This study was conducted in an outpatient clinic over a period of 10 months. Eligible patients were those who have been suffering from Vasculogenic ED for at least 6 months, and their International Index of Erectile Function score in the erectile function domain (IIEF-EF, ) was between 9 and 25. Patients who had hormonal, neurological or psychological pathology or have undergone radical prostatectomy were excluded.
The treatment consisted of 4 weekly sessions; in each session 4 areas were treated consecutively: left and right sides of the Crura and the Corpora Cavernosa. Shockwaves were delivered with a maximum energy of 0.09mJ/mm2; therefore, no anesthesia was required. During the treatment period (22 days) and 3 weeks prior it, no phosphodiesterase type 5 inhibitors (PDE5-I) were used.
Erectile function was evaluated by means of IIEF-EF, questions 2-3 of the Sexual Encounter Profile (SEP), questions 1-2 of the Global Assessment Questions (GAQ) and the Erection Hardness Score (EHS), at baseline and at 1, 3 and 6 months post treatment. Success was defined as positive answer to both SEP questions and both GAQ questions, EHS of 3 or higher and an increase of IIEF-EF score from baseline to the third follow up (6 months post treatment) according to the severity of the symptoms .
Out of 25 patients who were enrolled to this study, 24 have finished the full treatment series. The mean age of these patients was 62.58 ± 8.32 (45-74) years and the mean duration of their ED was 4.84 ± 4.46 (1-20) years. 52% were smokers, 26% had diabetes, 58% had high cholesterol levels, 37% had a cardiovascular disease and 47% had hypertension. 74% of the patients had a positive response to PDE5 inhibitors.
All patients were instructed to use PDE5 inhibitors during the 4 weeks prior baseline evaluation. At the end of the treatment and during the follow-up period patients were using PDE5 inhibitors as needed.
At the most recent follow-up of each patient, 40% of the PDE5i non-responders and 78% of the responders achieved positive outcomes at all 4 evaluation questionnaires. 42.8% of the responders stopped using PDE5 inhibitors at 6 month follow-up. Out of these patients, 83% achieved positive outcomes at all 4 evaluation questionnaires. The overall percentage of patients who achieved positive outcomes at all 4 evaluation questionnaires was 70%. None of the patients have reported on pain during or after treatment. No adverse events were reported.
This pilot study was designed for assessing the efficacy of a novel device dedicated for the treatment of erectile dysfunction and based on an original technology that enables the delivery of low-intensity shockwaves onto a long focal area. The subjects in this study included also patients with multiple co-morbidities, different degrees of response to PDE5 inhibitors and wide range of ED severities. The results of this study demonstrate a possible alternative treatment for some of the patients who did not respond to first-line oral pharmacotherapy and thanks to this treatment may avoid turning to other therapy options which are less convenient to use. In parallel, these data imply on a potential mean to eliminate the need for PDE5 inhibitors which may significantly improve patients' quality of life. In order to establish the overall effect of this treatment on the quality of life of ED patients, a larger study with longer follow-up duration is required.
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