2.1. Study Design and Ethical Details
We designed a single-center prospective randomized pilot study at the Urology Unit of the University of Campania “Luigi Vanvitelli” (Naples, Italy) that was conducted between April 2019 and June 2020. No placebo or blinding was applied. The study was approved by the local Ethics Committee. The research was conducted according to the Declaration of Helsinki on the ethical principles for medical research involving human subjects [