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Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07393711
Acronym
DIOX-PCNL
Enrollment
95
Registered
2026-02-06
Start date
2026-03-01
Completion date
2026-12-30
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Calculi, Nephrolithiasis, Urinary Tract Infections

Keywords

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

Brief 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.

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

DRUGDioxidine

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

PROCEDUREPercutaneous Nephrolithotripsy (PCNL)

Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.

Sponsors

West Kazakhstan Marat Ospanov Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Participants are assigned to receive standard PCNL with or without adjunctive intrarenal dioxidine instillation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of infection-related kidney stones12 months post-PCNLProportion of patients with recurrent infection-related kidney stones within 12 months after percutaneous nephrolithotripsy, assessed by imaging studies (ultrasound or CT) and clinical evaluation.

Countries

Kazakhstan

Contacts

CONTACTTalgat A Imzharov
t.imzharov@zkmu.kz+77054442410
STUDY_DIRECTORBazylbek S Zhakiev, MD

West Kazakhstan Marat Ospanov Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026