Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy

NCT07393711 | Not Yet Recruiting

• 2 other identifiers: Approval No. 11 (11.16/03)EC Approval 11-16/03
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi; Nephrolithiasis; Urinary Tract Infections

Keywords

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

Outcome Measures

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.

  12 months post-PCNL

Study Arms (2)

Intrarenal Dioxidine Group

EXPERIMENTAL

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

Drug: Dioxidine; Procedure: Percutaneous Nephrolithotripsy (PCNL)

Standard Treatment Group

ACTIVE COMPARATOR

Participants undergo standard PCNL without adjunctive dioxidine.

Procedure: Percutaneous Nephrolithotripsy (PCNL)

Interventions

Dioxidine DRUG

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

Intrarenal Dioxidine Group

Percutaneous Nephrolithotripsy (PCNL) PROCEDURE

Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.

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

Intrarenal Dioxidine Group; Standard Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patients undergoing percutaneous nephrolithotripsy (PCNL)
• Infection-related kidney stones
• Ability to provide written informed consent

You may not qualify if:

• Age \<18 years
• Pregnancy or breastfeeding
• Known hypersensitivity to dioxidine
• Severe renal insufficiency or end-stage renal disease
• Severe comorbid conditions that preclude participation

Sponsors & Collaborators

• West Kazakhstan Marat Ospanov Medical University: lead

Study Sites (1)

West Kazakhstan Marat Ospanov Medical University

Aqtöbe, 030000, Kazakhstan

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Urinary Tract Infections

Interventions

dioxidine; Lithotripsy

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bazylbek S Zhakiev, MD

  West Kazakhstan Marat Ospanov Medical University

  STUDY DIRECTOR

Central Study Contacts

Talgat A Imzharov

CONTACT

+77054442410; t.imzharov@zkmu.kz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)