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| ID | Type | Description | Link |
|---|---|---|---|
| EC Approval 11-16/03 | Other Identifier | Marat Ospanov Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrarenal Dioxidine Group | Experimental | Participants undergo PCNL followed by intrarenal instillation of dioxidine to prevent infection-related stone recurrence. |
|
| Standard Treatment Group | Active Comparator | Participants undergo standard PCNL without adjunctive dioxidine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dioxidine | Drug | Intrarenal instillation of dioxidine solution after PCNL to reduce bacterial colonization and prevent recurrence of infection-related stones. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Talgat A Imzharov | Contact | +77054442410 | t.imzharov@zkmu.kz |
| Name | Affiliation | Role |
|---|---|---|
| Bazylbek S Zhakiev, MD | West Kazakhstan Marat Ospanov Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Kazakhstan Marat Ospanov Medical University | Aqtöbe | 030000 | Kazakhstan |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C001077 | dioxidine |
| D008096 | Lithotripsy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Participants are assigned to receive standard PCNL with or without adjunctive intrarenal dioxidine instillation.
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| Percutaneous Nephrolithotripsy (PCNL) | Procedure | Standard percutaneous nephrolithotripsy procedure for removal of kidney stones. |
|
|
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |