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NCT Number: NCT07393711

Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Kazakhstan Marat Ospanov Medical University

Aqtöbe, 030000, Kazakhstan

Location contact

Talgat A Imzharov

CONTACT

[email protected]

87054442410

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dioxidine

Drug

Intrarenal instillation of dioxidine solution after PCNL to reduce bacterial colonization and prevent recurrence of infection-related stones.

Other names: Intrarenal Dioxidine Instillation, Dioxidine Solution

Percutaneous Nephrolithotripsy (PCNL)

Procedure

Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.

Other names: PCNL, Percutaneous Stone Removal, Percutaneous Lithotripsy

Primary outcomes

  1. Recurrence of infection-related kidney stones

    Time frame: 12 months post-PCNL

    Proportion of patients with recurrent infection-related kidney stones within 12 months after percutaneous nephrolithotripsy, assessed by imaging studies (ultrasound or CT) and clinical evaluation.

Study contacts

Contact information is provided by the study sponsor or research team.

Talgat A Imzharov

CONTACT

[email protected]

+77054442410

Sponsors and collaborators

Lead sponsor

West Kazakhstan Marat Ospanov Medical University

Other

Registry information

Official study title

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

Acronym: DIOX-PCNL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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