Clinical trial NCT06651294: Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urolithiasis
Keywords: Elimination of residual fragments
Flexible ureterorenoscopy
Renal calculi
Phytotherapeutic extracts
Lead sponsor: Neopharm Bulgaria Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter.
timeFrame: 90 days + 5 days after endourological treatment.
Secondary outcomes:
measure: Percentage, size and location of residual fragments.
timeFrame: 90 days + 5 days after endourological treatment.
measure: Number of subjects with complications associated with residual fragments or their elimination
timeFrame: at 30 days and 90 days + 5 days after endourological treatment.
measure: Percentage of subjects receiving analgesics
timeFrame: Up to 90 days after endourological treatment.
measure: Duration of analgesics administration
timeFrame: Up to 90 days after endourological treatment.
measure: Severity of pain
timeFrame: Up to 90 days after endourological treatment.
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: MHAT "Heart and Brain"
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski"
city: Pleven
country: Bulgaria
facility: University Hospital for Active Treatment "Saint Marina"
city: Plovdiv
country: Bulgaria
facility: UMHAT "St. George"
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska"
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: UMBALSM "N. I. Pirogov"
city: Sofia
country: Bulgaria
facility: UMHAT "Sofiamed"
Study officials:
affiliation: UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University
name: Marin Georgiev, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Military Medical Academy, Head of Department of Urology and Nephrology
name: Iliya Saltirov, Prof, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UMHAT "Saint Marina", Head of Department of Urology, Medical University of Pleven
name: Boyan Atanasov, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMHAT "St. George", Head of Department of Urology
name: Madjid Kadim, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMHAT "Kaspela", Department of Urology
name: Stanislav Valkanov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MHAT "Heart and Brain", Head of Department of Urology
name: Deyan Anakievski, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMHAT "Sofiamed", Head of Department of Urology
name: Kaloqn Davidov, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMBALSM "N. I. Pirogov"
name: Boris Mladenov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMHAT "Dr. Georgi Stranski", Head of Department of Urology
name: Nikolay Kolev, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MHAT "St. Anna - Varna",Head of Department of Urology
name: Tosho Ganev, PhD
role: PRINCIPAL_INVESTIGATOR
References: