madman
Super Moderator
Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial
Abstract
Introduction: Low-intensity extracorporeal shock wave therapy (Li-ESWT) is a new treatment modality for erectile dysfunction (ED). Our aim was to evaluate the treatment outcome of Li-ESWT for ED in single-blind, placebo controlled, randomized clinical trial.
Methods: Sixty patients were randomized into 2 age-matched groups: Group A – treatment and Group B – placebo. Treatment consisted of 4 sessions on the PiezoWave2 unit (R. Wolf and ELvation Medical). Effectiveness was assessed according to the International Index of Erectile Function 5 (IIEF-5), Erectile Hardness Score (EHS), questions 2 and 3 of the Sexual Encounter Profile (SEP 2, SEP 3), and Global Assessment Question (GAQ) scores at baseline and 4 and 12 weeks after treatment. We evaluated patient’s and partner’s subjective satisfaction.
Results: A statistically significant difference between the groups was found at 4 and 12 weeks after treatment with regard to the quality of erection as measured by the IIEF-5 (p = 0.049 and p < 0.001, respectively), the EHS after week 12 (p < 0.001), an increase in the EHS after 4 and 12 weeks (p = 0.030 and p < 0.001, respectively), after 12 weeks in GAQ (p < 0.001), SEP 2 (p = 0.05), SEP 3 (p < 0.001), and patient’s satisfaction (p < 0.001) and partner’s satisfaction (p < 0.001).
Conclusions: The randomized single-blind study confirms that Li-ESWT significantly improves erectile function.
Li-ESWT is a potential restorative therapy for post-RP ED; however, additional preclinical and clinical studies are required before its widespread use [32].
Current nonsurgical treatment options of ED, including PDE5i, provide temporary relief but have failed to provide a permanent improvement of the condition. The use of Li-ESWT has previously been described in other disease contexts, such as ischemic heart disease, bone fractures, and burns, in which it improves neoangiogenesis; similar principles seem to apply in the erectile tissue. The major potential advantage of the treatment, therefore, is the possibility to restore natural EF. Li-ESWT has also been suggested to improve the effect of PDE5i in non-responders, reducing the need for more invasive treatment. The search for the clinical value of Li-ESWT for ED represents a dynamic and continuing field of enquiry [34].
Therapeutic potential of Li-ESWT is in sexual medicine other than ED. In Peyronie’s disease, Li-ESWT has been shown to decrease pain but not clinically relevant benefits regarding plaque size or penile curvature have been shown in randomized clinical trials. The application of Li-ESWT to the tissue after stem cell transplantation may increase the erectile response following cavernous nerve injury due to diabetic damage. Li-ESWT has shown promise in pelvic pain. Other studies are needed, before considering this new treatment as the new standard for the treatment of ED [35].
Limitations
The limitations of the study are the relatively small number of patients, short follow-up period and only single-blind study.
Abstract
Introduction: Low-intensity extracorporeal shock wave therapy (Li-ESWT) is a new treatment modality for erectile dysfunction (ED). Our aim was to evaluate the treatment outcome of Li-ESWT for ED in single-blind, placebo controlled, randomized clinical trial.
Methods: Sixty patients were randomized into 2 age-matched groups: Group A – treatment and Group B – placebo. Treatment consisted of 4 sessions on the PiezoWave2 unit (R. Wolf and ELvation Medical). Effectiveness was assessed according to the International Index of Erectile Function 5 (IIEF-5), Erectile Hardness Score (EHS), questions 2 and 3 of the Sexual Encounter Profile (SEP 2, SEP 3), and Global Assessment Question (GAQ) scores at baseline and 4 and 12 weeks after treatment. We evaluated patient’s and partner’s subjective satisfaction.
Results: A statistically significant difference between the groups was found at 4 and 12 weeks after treatment with regard to the quality of erection as measured by the IIEF-5 (p = 0.049 and p < 0.001, respectively), the EHS after week 12 (p < 0.001), an increase in the EHS after 4 and 12 weeks (p = 0.030 and p < 0.001, respectively), after 12 weeks in GAQ (p < 0.001), SEP 2 (p = 0.05), SEP 3 (p < 0.001), and patient’s satisfaction (p < 0.001) and partner’s satisfaction (p < 0.001).
Conclusions: The randomized single-blind study confirms that Li-ESWT significantly improves erectile function.
Li-ESWT is a potential restorative therapy for post-RP ED; however, additional preclinical and clinical studies are required before its widespread use [32].
Current nonsurgical treatment options of ED, including PDE5i, provide temporary relief but have failed to provide a permanent improvement of the condition. The use of Li-ESWT has previously been described in other disease contexts, such as ischemic heart disease, bone fractures, and burns, in which it improves neoangiogenesis; similar principles seem to apply in the erectile tissue. The major potential advantage of the treatment, therefore, is the possibility to restore natural EF. Li-ESWT has also been suggested to improve the effect of PDE5i in non-responders, reducing the need for more invasive treatment. The search for the clinical value of Li-ESWT for ED represents a dynamic and continuing field of enquiry [34].
Therapeutic potential of Li-ESWT is in sexual medicine other than ED. In Peyronie’s disease, Li-ESWT has been shown to decrease pain but not clinically relevant benefits regarding plaque size or penile curvature have been shown in randomized clinical trials. The application of Li-ESWT to the tissue after stem cell transplantation may increase the erectile response following cavernous nerve injury due to diabetic damage. Li-ESWT has shown promise in pelvic pain. Other studies are needed, before considering this new treatment as the new standard for the treatment of ED [35].
Limitations
The limitations of the study are the relatively small number of patients, short follow-up period and only single-blind study.
