Efficacy, Satisfaction, and Safety of Low-Intensity, Large-Area Shock Wave Therapy With Dual-Probe Energy Delivery for Erectile Dysfunction

We evaluated the efficacy and safety of a new low-intensity extracorporeal shockwave therapy generator, the Morenova system (Direx Systems GmbH, Wiesbaden, Germany), that offers fewer treatments and shorter treatment times through dual-probe energy delivery for patients with erectile dysfunction (ED). We additionally examined whether aging affects treatment efficacy and whether there are independent factors that predict treatment efficacy. To evaluate efficacy from the viewpoint of patient satisfaction, free comments written by the patients were analyzed by artificial intelligence (AI) to clarify the percentage of responses judged to be "positive." This study included 64 male patients (56.5 ± 1.5 years) with ED who had undergone treatment with the Morenova. The treatment involves delivering a total of 1,800 shock waves (900 from each of the two applicators) with an energy density of 1.8 mJ/mm2 to the sides of the penis and the perineum. Each patient underwent five sessions conducted two to three times per week. Efficacy was evaluated by two specific questionnaires (Sexual Health Inventory for Men, SHIM, and Erection Hardness Score), and adverse events were confirmed by direct questioning of the patients. The degree of improvement was evaluated for five age groups of patients categorized in their 30s, 40s, 50s, 60s, and 70s and older. The patients' free-form feedback on their impressions and opinions of the treatment was also evaluated by AI. We found significant improvement between pretreatment and one-month posttreatment score of the SHIM (from 11.5 ± 0.5 to 16.6 ± 0.7; p < 0.01) and Erection Hardness Score (from 1.94 ± 0.09 to 2.83 ± 0.10; p < 0.01), respectively. Significant improvement between pretreatment and three-month posttreatment scores from the two questionnaires was also found (from 11.5 ± 0.5 to 16.6 ± 0.7; p < 0.01 and from 1.94 ± 0.09 to 2.66 ± 0.13; p < 0.01, respectively). Morenova treatment caused no adverse events. The degree of improvement was not affected by the patients' age. Only pretreatment Erection Hardness Score was found to be an independent influencing factor for the efficacy of the treatment. Analysis by AI of patients' free-form feedback showed that 70% of the opinions were positive. We concluded that treatment with the Morenova system is an effective and safe option for ED, which should be tried in all age groups, as approximately 70% of patients reported satisfaction with the treatment. The patients appeared to be satisfied with treatment by Morenova because of fewer clinic visits and shorter treatment times, coupled with a good response.