Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

Inclusion Criteria:

1. Male or female 18 to 65 years of age.

2. The subject has signed informed consent approved by an Ethics Committee and agreesto the on-site study visits.

3. A stone confirmed by NCCT of kidney, ureter and urinary bladder for assessment ofsize, number, location and stone density, within 90 days of fURS.

4. Single or multiple kidney stones with total size of 10x10 mm to 15x10 mm.

5. Stone density 1001 - 1400 Hounsfield units (HU).

6. Subjects post fURS for laser lithotripsy of kidney stone.

7. Residual fragments < 4 mm after fURS confirmed by ultrasound on first postoperativeday.

8. Subjects post one fURS.

9. fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidneyor urinary bladder, serious bleeding or other complications.

10. No recent ureterorenoscopy within the last 6 months.

11. Body mass index 17.0 - 29.99 kg/m2 118

12. In Investigator's opinion, the subject can comply with the visit schedule and thetreatment regimen and is capable of completing the study.

13. The subject has a smartphone and is capable of using it.

Exclusion Criteria:

1. Subjects with anatomical anomalies revealed by ultrasound - stenosis of thepyelo-ureteral junction, horseshoe kidney, kidney malrotation, calycealdiverticulum, and others.

2. Ureteral stenosis.

3. History of ipsilateral renal surgery.

4. Hydronephrosis.

5. Permanent JJ stent.

6. Any conditional or absolute contraindications for fURS.

7. Combined ipsilateral stone in the ureter or contralateral stone in the upper urinarycanal or a stone in the lower urinary canal, requiring simultaneous surgery.

8. Subjects with positive urine culture, until resolution.

9. History of endourological intervention (e.g. nephrostoma, ureteral catheter) beforefURS.

10. Stone density <1000 and >1401 HU;

11. Uncontrolled diabetes mellitus (HbA1c >9%).

12. Renal insufficiency.

13. Subjects with arterial hypertension.

14. Subjects with prostate adenoma.

15. Allergy or hypersensitivity to any of the ingredients of the investigationalproduct.

16. BMI ≥ 30 kg/m2.

17. Women who are pregnant or lactating; women who plan on getting pregnant during thestudy.

18. Alcohol or drug abuse in the last year.

19. Unstable medical conditions, as determined by the Investigator.

20. Inability to comply with the study protocol.

21. Subjects who cannot understand or not capable of completing the study documents.

22. Inability to give informed consent.