Linear Low-Intensity Extracorporeal Shockwave Therapy as a Method for Penile Rehabilitation in Erectile Dysfunction Patients after Radical Prostatectomy: A Randomized, Single-Blinded, Sham-Controlled Clinical Trial.

INTRODUCTION: The objective of this study was to investigate the effect and feasibility of linear low-intensity extracorporeal shockwave therapy (LI-LiESWT) as a penile rehabilitation method for erectile dysfunction (ED) after bilateral nerve-sparing (NS) radical prostatectomy (RP). METHODS: Patients who had undergone bilateral NS RP (either radical retropubic prostatectomy or robot-assisted laparoscopic RP), 3 or more months prior to the study, and who had no ED preoperatively and were suffering from mild to severe postoperative ED were included in the study. Four treatments were given over a 4-week period, using the PiezoWave2 device with a linear shockwave applicator and the linear shockwave tissue coverage (LSTC-ED®) technique. If the improvement in erectile function was still considered insufficient (less than an IIEF-5 score of 22-25) at 2 months after the start of LI-LiESWT, penile rehabilitation was supplemented by pharmacological penile rehabilitation. The final effect of treatment was evaluated after 12 months. The main outcome measure was changes in the five-item International Index of Erectile Function (IIEF-5) score. RESULTS: Between September 2019 and September 2020, a total of 40 patients were included in the study and randomly divided into 2 groups: treatment group and sham group. Eight patients were excluded from the study and were not evaluated due to other conditions which required additional treatment (COVID-19 disease, postoperative incontinence, urethral stricture, and ischemic stroke). Thirty-two patients were included in the final analysis: 16 in the control group and 16 in the intervention group. At 6 months from the end of treatment, patients in both the treatment and the sham group achieved physiological IIEF-5 values, and the beneficial effect persisted for 12 months after the end of treatment. CONCLUSIONS: LI-LiESWT using the LSTC-ED® technique is a suitable and safe method for penile rehabilitation in patients with ED after bilateral NS RP, not only because of the vasculogenic effect of LI-LiESWT but also because of its neuroprotective and/or regenerative effects.

Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial.

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.