Evaluating Neorenal Forte to Fully Remove Residual Kidney Stone Fragments After Flexible Ureterorenoscopy with Laser Treatment in Adults

What this Trial Is About

This research aims to evaluate the effectiveness of a specialized formula of phytotherapeutic extracts called Neorenal Forte in helping adults fully eliminate residual kidney stone fragments after flexible ureterorenoscopy with laser lithotripsy, a procedure to treat kidney stones. The study focuses on adults aged 18 to 65 years who have undergone this procedure for kidney stones, assessing the ability of Neorenal Forte to aid in removing remaining stone fragments and reduce related complications. Participants receive either Neorenal Forte or a placebo in a randomized, triple-blind design. The treatment starts with 2 tablets twice daily for up to 10 days after the surgical procedure, followed by 1 tablet twice daily for 80 days. This dosing regimen aims to support the complete elimination of residual fragments or fragments smaller than 2 mm in diameter over the treatment period. During the study, participants attend scheduled visits where ultrasound and CT scans assess residual stone fragments, the size and location of fragments, and any complications from the fragments or their removal. Researchers also track pain severity, analgesic use, and treatment adherence. The primary outcome is the percentage of subjects without residual fragments or with fragments 2 mm or smaller, measured 90 days plus 5 days after the procedure. The total participation lasts about three months post-procedure, with safety and efficacy closely monitored throughout.

Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments