Using Neorenal Forte to eliminate kidney stone fragments

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.

This study is testing if a new supplement called Neorenal Forte can help adults get rid of leftover kidney stone fragments after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Neopharm Bulgaria Ltd. (Industry-sponsored)
• Locations: 9 sites (Burgas and 8 other locations)
• Trial ID: NCT06651294 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Neorenal Forte, a specialized formula of phytotherapeutic extracts, in completely eliminating residual kidney stone fragments after flexible ureterorenoscopy (fURS) in adults. Participants will receive either Neorenal Forte or a placebo for at least three months following their endourological procedures. The primary goal is to assess the percentage of complete elimination of residual fragments or fragments smaller than 2 mm in diameter, thereby determining the efficacy and safety of the treatment. This approach aims to minimize both short-term and long-term complications associated with urolithiasis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who have undergone fURS for kidney stones and have residual fragments smaller than 4 mm.

Not a fit: Patients with recent ureterorenoscopy or those with complications from fURS may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of kidney stones by ensuring complete elimination of residual fragments, reducing the risk of future complications.

How similar studies have performed: While the use of phytotherapeutic extracts in urolithiasis treatment is promising, this specific approach with Neorenal Forte is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 agrees to the on-site study visits.
3. 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.
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 postoperative day.
8. Subjects post one fURS.
9. fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidney or 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 the treatment 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 the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, 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 urinary canal 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) before fURS.
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 investigational product.
16. BMI ≥ 30 kg/m2.
17. Women who are pregnant or lactating; women who plan on getting pregnant during the study.
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.

Where this trial is running

Burgas and 8 other locations

• MHAT "Heart and Brain" — Burgas, Bulgaria (Recruiting)
• UMHAT "Dr. Georgi Stranski" — Pleven, Bulgaria (Recruiting)
• University Hospital for Active Treatment "Saint Marina" — Pleven, Bulgaria (Recruiting)
• UMHAT "St. George" — Plovdiv, Bulgaria (Recruiting)
• UMHAT Kaspela — Plovdiv, Bulgaria (Recruiting)
• UMHAT "Alexandrovska" — Sofia, Bulgaria (Recruiting)
• Military Medical Academy — Sofia, Bulgaria (Recruiting)
• UMBALSM "N. I. Pirogov" — Sofia, Bulgaria (Recruiting)
• UMHAT "Sofiamed" — Sofia, Bulgaria (Recruiting)

Study contacts

• Principal investigator: Marin Georgiev, Prof, PhD — UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University
• Study coordinator: Margarita Futekova

Conditions Urolithiasis; Elimination of residual fragments; Flexible ureterorenoscopy; Renal calculi; Phytotherapeutic extracts