ClinicalTrials.gg
Not yet recruitingNCT07393711DIOX-PCNLUpdated Feb 11, 2026

Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy

An interventional study of Dioxidine and Percutaneous Nephrolithotripsy (PCNL) in Kidney Calculi, Nephrolithiasis and Urinary Tract Infections, sponsored by West Kazakhstan Marat Ospanov Medical University. Not yet recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by West Kazakhstan Marat Ospanov Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Kidney Calculi
  • Nephrolithiasis
  • Urinary Tract Infections

Keywords

  • Percutaneous nephrolithotomy
  • PCNL
  • Infection stones
  • Struvite stones
  • Dioxidine
  • Intrarenal instillation
  • Stone recurrence
  • Metaphylaxis
03

In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's planned enrollment of 95 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

West Kazakhstan Marat Ospanov Medical University is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥18 years

Patients undergoing percutaneous nephrolithotripsy (PCNL)

Infection-related kidney stones

Ability to provide written

Exclusion criteria

Exclusion Criteria:

Age \<18 years

Pregnancy or breastfeeding

Known to dioxidine

Severe renal insufficiency or end-stage renal disease

Severe comorbid conditions that preclude participation

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
95 participants (estimated)

Study arms

  • Experimental
    Intrarenal Dioxidine Group

    Participants undergo PCNL followed by intrarenal instillation of dioxidine to prevent infection-related stone recurrence.

    Drug: Dioxidine · Procedure: Percutaneous Nephrolithotripsy (PCNL)

  • Active comparator
    Standard Treatment Group

    Participants undergo standard PCNL without adjunctive dioxidine.

    Procedure: Percutaneous Nephrolithotripsy (PCNL)

Interventions

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

    Also known as: Intrarenal Dioxidine Instillation, Dioxidine Solution

  • ProcedurePercutaneous Nephrolithotripsy (PCNL)

    Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.

    Also known as: PCNL, Percutaneous Stone Removal, Percutaneous Lithotripsy

06

What researchers measure

Primary outcomes

  1. Recurrence of infection-related kidney stones

    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.

    Time frame: 12 months post-PCNL

07

Study locations

1 site
  • West Kazakhstan Marat Ospanov Medical University
    Aqtöbe, 030000, Kazakhstan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07393711
Lead sponsor
West Kazakhstan Marat Ospanov Medical University
Responsible party
Talgat A. Imzharov (Principal Investigator, West Kazakhstan Marat Ospanov Medical University) — Principal investigator
First posted
Feb 6, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Feb 11, 2026

Study contacts

Talgat A Imzharov
Contact
t.imzharov@zkmu.kz
+77054442410
Bazylbek S Zhakiev, MD
study director · West Kazakhstan Marat Ospanov Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Dioxidine

Start the discussion