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.

Overview

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.

Interventions

• Dietary supplement Neorenal Forte
  This specialized formulation of phytotherapeutic extracts consists of proprietary Betula pendula leaves dry extract, Herniaria glabra, Viburnum opulus, Elymus (Agropiren) repens. The product contains supplementary ingredients: microcrystalline cellulose, povidone, magnesium stearate, colorant film (brilliant blue FCF, iron dioxide).
• Dietary supplement Placebo
  The placebo product will be identical to the active form and will have the same composition but without the proprietary extract from Betula pendula, Herniaria glabra, Viburnum opulus, Elymus (Agropiren) repens.

Primary outcome measures

• Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter. [Time frame: 90 days + 5 days after endourological treatment.]

Secondary outcome measures (5)

• Percentage, size and location of residual fragments. [Time frame: 90 days + 5 days after endourological treatment.]
• Number of subjects with complications associated with residual fragments or their elimination [Time frame: at 30 days and 90 days + 5 days after endourological treatment.]
• Percentage of subjects receiving analgesics [Time frame: Up to 90 days after endourological treatment.]
• Duration of analgesics administration [Time frame: Up to 90 days after endourological treatment.]
• Severity of pain [Time frame: Up to 90 days after endourological treatment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Bulgaria · 9 centers

• MHAT "Heart and Brain" — Burgas
• UMHAT "Dr. Georgi Stranski" — Pleven
• University Hospital for Active Treatment "Saint Marina" — Pleven
• UMHAT "St. George" — Plovdiv
• UMHAT Kaspela — Plovdiv
• UMHAT "Alexandrovska" — Sofia
• Military Medical Academy — Sofia
• UMBALSM "N. I. Pirogov" — Sofia
• … and 1 more center

Identifiers

NCT: NCT06651294 · NERFA 2501-lit-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗