Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy (DIOX-PCNL)

February 8, 2026 updated by: Talgat A. Imzharov, West Kazakhstan Marat Ospanov Medical University

Evaluation of the Effectiveness of Intrarenal Dioxidine Metaphylaxis for Preventing Recurrence of Infection 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kazakhstan
      • Aqtöbe, Kazakhstan, 030000
        • West Kazakhstan Marat Ospanov Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrarenal Dioxidine Group
Participants undergo PCNL followed by intrarenal instillation of dioxidine to prevent infection-related stone recurrence.
Drug: Dioxidine
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
Procedure: Percutaneous Nephrolithotripsy (PCNL)
Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.
Other Names:
  • PCNL
  • Percutaneous Stone Removal
  • Percutaneous Lithotripsy
Active Comparator: Standard Treatment Group
Participants undergo standard PCNL without adjunctive dioxidine.
Procedure: Percutaneous Nephrolithotripsy (PCNL)
Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.
Other Names:
  • PCNL
  • Percutaneous Stone Removal
  • Percutaneous Lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-PCNL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Kazakhstan Marat Ospanov Medical University

Investigators

  • Study Director: Bazylbek S Zhakiev, MD, West Kazakhstan Marat Ospanov Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Approval No. 11 (11.16/03)
  • EC Approval 11-16/03 (Other Identifier: Marat Ospanov Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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