Efficacy and Safety of Neorenal Forte as Adjuvant Treatment for the Complete Elimination of Residual Fragments After Flexible Ureterorenoscopy With Laser Lithotripsy for Renal Calculi.
The purpose of this study is to evaluate the efficacy of a specialized formula of phytotherapeutic extracts (Neorenal Forte) aiding the complete elimination of residual fragments after fURS in adults.
• Male or female 18 to 65 years of age.
• The subject has signed informed consent approved by an Ethics Committee and agrees to the on-site study visits.
• A stone confirmed by NCCT of kidney, ureter and urinary bladder for assessment of size, number, location and stone density, within 90 days of fURS.
• Single or multiple kidney stones with total size of 10x10 mm to 15x10 mm.
• Stone density 1001 - 1400 Hounsfield units (HU).
• Subjects post fURS for laser lithotripsy of kidney stone.
• Residual fragments \< 4 mm after fURS confirmed by ultrasound on first postoperative day.
• Subjects post one fURS.
• fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidney or urinary bladder, serious bleeding or other complications.
⁃ No recent ureterorenoscopy within the last 6 months.
⁃ Body mass index 17.0 - 29.99 kg/m2 118
⁃ In Investigator's opinion, the subject can comply with the visit schedule and the treatment regimen and is capable of completing the study.
⁃ The subject has a smartphone and is capable of using it.