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Not yet recruiting NCT07393711

Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy

No phase Interventional Kidney Calculi Nephrolithiasis Urinary Tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dioxidine, Percutaneous Nephrolithotripsy (PCNL).
Who it may be relevant to
Registry conditions: Kidney Calculi, Nephrolithiasis, Urinary Tract Infections. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Kazakhstan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effectiveness of Intrarenal Dioxidine Metaphylaxis for Preventing Recurrence of Infection Stones After Percutaneous Nephrolithotripsy

Overview

Kidney stone recurrence, particularly infection-related stones, remains a significant clinical problem after percutaneous nephrolithotripsy (PCNL). Bacterial colonization and persistent infection are recognized contributors to stone recurrence. This study evaluates the effectiveness of intrarenal dioxidine instillation as a metaphylactic measure to reduce recurrence of infection-related kidney stones following PCNL. Patients undergoing PCNL will receive standard treatment, with or without adjunctive intrarenal dioxidine administration. The study aims to assess whether this approach reduces stone recurrence and infection-related complications.

Detailed description

Infection-related kidney stones are associated with urease-producing bacteria and carry a high risk of recurrence even after successful surgical removal. Percutaneous nephrolithotripsy (PCNL) is the standard treatment for large or complex renal calculi; however, residual infection and bacterial biofilms may contribute to recurrent stone formation.

Metaphylaxis strategies targeting infection control may reduce recurrence rates. Dioxidine is an antimicrobial agent with broad-spectrum activity against gram-positive and gram-negative bacteria and has been used locally in urological practice. Intrarenal instillation may help reduce bacterial colonization in the collecting system.

The purpose of this study is to evaluate the clinical effectiveness and safety of intrarenal dioxidine instillation as a metaphylactic intervention after PCNL for infection-related kidney stones. Outcomes include stone recurrence, urinary tract infection rates, and postoperative complications. The results may help define improved metaphylaxis strategies for patients with infection-related nephrolithiasis.

Interventions

  • Drug Dioxidine
    Intrarenal instillation of dioxidine solution after PCNL to reduce bacterial colonization and prevent recurrence of infection-related stones.
  • Procedure Percutaneous Nephrolithotripsy (PCNL)
    Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.

Primary outcome measures

  • Recurrence of infection-related kidney stones [Time frame: 12 months post-PCNL]

Eligibility criteria

Inclusion criteria

Age ≥18 years

Patients undergoing percutaneous nephrolithotripsy (PCNL)

Infection-related kidney stones

Ability to provide written informed consent

Exclusion criteria

Age <18 years

Pregnancy or breastfeeding

Known hypersensitivity to dioxidine

Severe renal insufficiency or end-stage renal disease

Severe comorbid conditions that preclude participation

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
Open label
Primary purpose
Prevention

Study locations

Kazakhstan · 1 center
  • West Kazakhstan Marat Ospanov Medical University — Aqtöbe

Identifiers

NCT: NCT07393711 · Approval No. 11 (11.16/03) · EC Approval 11-16/03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗