Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

The study is being initiated to support the informed decision making by healthcare specialists on the initiation of a specific and safe formula of phytotherapeutic extracts with duration at least three months after endourological procedures, as a routine part of urolithiasis treatment, aiding the complete elimination of residual fragments, which will allow minimizing of the short-term and long-term complications.

By evaluating the percentage of complete elimination of residual fragments or fragments < 2 mm in diameter, we aim to estimat the efficacy and safety of Neorenal Forte.

Inclusion criteria

• 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.

Exclusion criteria

• Subjects with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, and others.
• Ureteral stenosis.
• History of ipsilateral renal surgery.
• Hydronephrosis.
• Permanent JJ stent.
• Any conditional or absolute contraindications for fURS.
• Combined ipsilateral stone in the ureter or contralateral stone in the upper urinary canal or a stone in the lower urinary canal, requiring simultaneous surgery.
• Subjects with positive urine culture, until resolution.
• History of endourological intervention (e.g. nephrostoma, ureteral catheter) before fURS.
• Stone density <1000 and >1401 HU;
• Uncontrolled diabetes mellitus (HbA1c >9%).
• Renal insufficiency.
• Subjects with arterial hypertension.
• Subjects with prostate adenoma.
• Allergy or hypersensitivity to any of the ingredients of the investigational product.
• BMI ≥ 30 kg/m2.
• Women who are pregnant or lactating; women who plan on getting pregnant during the study.
• Alcohol or drug abuse in the last year.
• Unstable medical conditions, as determined by the Investigator.
• Inability to comply with the study protocol.
• Subjects who cannot understand or not capable of completing the study documents.
• Inability to give informed consent.