The efficacy of combined low intensity shock wave therapy (LI-ESWT) and tadalafil 5mg daily in diabetic patients with Erectile Dysfunction (ED): The results of a case-control retrospective study

Aim of the Study: To evaluate the efficacy of combination therapy with Low Intensity Shock Wave Therapy (LISWT) and Tadalafil 5 mg daily (TAD oad) in diabetic patients with ED and to compare protocols of LISWT characterized by different number of shock waves for session. Materials and Methods: We performed a retrospective observational case-control study. We enrolled diabetic patients with ED naïve for ED treatment. The case group (Group 1) consisted of patients who received TAD oad bed-time for 12 weeks and LISWT. Shockwaves were delivered by a probe attached to an electrohydraulic unit with a focused shockwave source. Shockwaves were delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20 min. Energy density was set at 0.09 mJ/mm2 and frequency at 120/min. The number of number of shock waves delivered during each session varied from 1500 to 2400. Treatment protocol consisted of 2 treatment sessions per week for 3 weeks. Patients with same demographic and clinical characteristics who received only TAD oad for 12 weeks served as controls (Group 2). International Index of Erectile Function (IIEF-5) scores recorded at baseline, at 4 and 12 weeks after the end of the treatment were compared. A subgroup analysis was performed according to the number of shock waves administered during each session (1500, 1800, 2400). Results: Thirty-one and 10 patients were enrolled in Group 1 and 2, respectively. Eleven, 10 and 10 patients belonging to the Group 1 received 1500, 1800 and 2400 hits, respectively. Mean baseline IIEF-5 scores were 16.8 and 15 in Group 1 and 2, respectively (p = 0.09). A statistically significant improvement of mean IIEF-5 score was observed in both groups at 4 weeks follow-up (19.7 and 18.3 in Groups 1 and 2, respectively) (p < 0.05 vs baseline). Mean IIEF-5 scores recorded at 12 weeks did not varied significantly in comparison to values recorded at 4 weeks (p = 0.1 in both groups). Inter-group analysis did not show significant differences at 4 and 12 weeks (p = 0.2 in both cases). Subgroup analysis revealed a statistically significant improvement of mean IIEF-5 score at 12 weeks with respect to 4 weeks only in patients who received 2400 hits (Figure 1). The percentage of patients in which it was registered a normalization of erectile function after 12 weeks of treatment was 20%, 27.2%, 20% and 50%, in Group 2 and in the subgroups of Group 1 treated with 1500,1800 and 2400 hits, respectively Discussion: The combination of TAD oad and LISWT leads to a statistically significant improvement of erectile function in diabetic patients with concomitant ED at 4 weeks follow-up, with a stable trend over time up to 12 weeks. The administration of 2400 hits for session allows to get an additional, significative improvement of erectile function at 12 weeks follow-up.