Urolithiasis
Conditions
Keywords
Elimination of residual fragments, Flexible ureterorenoscopy, Renal calculi, Phytotherapeutic extracts
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.
Interventions
DIETARY_SUPPLEMENTNeorenal 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_SUPPLEMENTPlacebo
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.
Sponsors
Neopharm Bulgaria Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Investigators will be provided with coded products which are identical in appearance. Each individual involved in the study will be blinded to the treatment assignment until study completion. Considering the established safety profile of the formula of phytotherapeutic extracts, emergency unblinding of treatment assignment will not be necessary. So no copies of the treatment assignments will be stored at the enrollment sites. No information about the subjects will be shared with the company conducting the randomization.
Intervention model description
Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 10x10x10 mm to 15x10x10 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter. | 90 days + 5 days after endourological treatment. | Percentage of subjects without stones or with fragments ≤ 2mm in diameter 3 months after fURS for laser lithotripsy of kidney stones, assessed by NCCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage, size and location of residual fragments. | 90 days + 5 days after endourological treatment. | The outcome will be categorized by radiologist via NCCT in 2 categories: ≤ 2mm, or \> 2mm. |
| Number of subjects with complications associated with residual fragments or their elimination | at 30 days and 90 days + 5 days after endourological treatment. | Febrility, renal colic, protracted hematuria, hydronephrosis grade I, II, III, IV. |
| Percentage of subjects receiving analgesics | Up to 90 days after endourological treatment. | Administration of antipyretics as reported on the patient diary - YES/NO |
| Duration of analgesics administration | Up to 90 days after endourological treatment. | Administration of antipyretics as reported on the patient diary - YES/NO |
| Severity of pain | Up to 90 days after endourological treatment. | Clinical assessment of pain is based on visual analogue scale (VAS) from 0 to 10 |
Countries
Bulgaria
Contacts
CONTACTMargarita Futekova
CONTACTStefan Tunev, PhD
PRINCIPAL_INVESTIGATORMarin Georgiev, Prof, PhD
UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University
PRINCIPAL_INVESTIGATORIliya Saltirov, Prof, MD, PhD, DSc
Military Medical Academy, Head of Department of Urology and Nephrology
PRINCIPAL_INVESTIGATORBoyan Atanasov, Prof, PhD
UMHAT "Saint Marina", Head of Department of Urology, Medical University of Pleven
PRINCIPAL_INVESTIGATORMadjid Kadim, Prof, PhD
UMHAT "St. George", Head of Department of Urology
PRINCIPAL_INVESTIGATORStanislav Valkanov, PhD
UMHAT "Kaspela", Department of Urology
PRINCIPAL_INVESTIGATORDeyan Anakievski, Prof, PhD
MHAT "Heart and Brain", Head of Department of Urology
PRINCIPAL_INVESTIGATORKaloqn Davidov, Prof, PhD
UMHAT "Sofiamed", Head of Department of Urology
PRINCIPAL_INVESTIGATORBoris Mladenov, PhD
UMBALSM "N. I. Pirogov"
PRINCIPAL_INVESTIGATORNikolay Kolev, Prof, PhD
UMHAT "Dr. Georgi Stranski", Head of Department of Urology
PRINCIPAL_INVESTIGATORTosho Ganev, PhD
MHAT "St. Anna - Varna",Head of Department of Urology
Outcome results
None listed