Kidney CalculiDIOX-PCNLNCT07393711
Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy
A study testing Dioxidine and Percutaneous Nephrolithotripsy (PCNL) in people with Kidney Calculi and Nephrolithiasis, run by West Kazakhstan Marat Ospanov Medical University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Calculi, Nephrolithiasis, Urinary Tract Infections
- What is being tested?
- Dioxidine and Percutaneous Nephrolithotripsy (PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients undergoing percutaneous nephrolithotripsy (PCNL)
- Infection-related kidney stones
- Ability to provide written informed consent
Who cannot join
- Age <18 years
- Pregnancy or breastfeeding
- Known hypersensitivity to dioxidine
- Severe renal insufficiency or end-stage renal disease
- Severe comorbid conditions that preclude participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site
West Kazakhstan Marat Ospanov Medical University
Aqtöbe, 030000
Talgat A Imzharov, 87054442410, t.imzharov@zkmu.kz
About this study
Official title: 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.
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.
- Conditions
- Kidney Calculi, Nephrolithiasis, Urinary Tract Infections
- Being tested
- Dioxidine, Percutaneous Nephrolithotripsy (PCNL)
- Keywords
- Percutaneous nephrolithotomy, PCNL, Infection stones, Struvite stones, Dioxidine, Intrarenal instillation, Stone recurrence, Metaphylaxis
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DioxidineDrug
Also called Intrarenal Dioxidine Instillation, Dioxidine Solution
Intrarenal instillation of dioxidine solution after PCNL to reduce bacterial colonization and prevent recurrence of infection-related stones.
Percutaneous Nephrolithotripsy (PCNL)Procedure or surgery
Also called PCNL, Percutaneous Stone Removal, Percutaneous Lithotripsy
Standard percutaneous nephrolithotripsy procedure for removal of kidney stones.
| Study group | Role | What they receive |
|---|---|---|
| Intrarenal Dioxidine Group | Experimental | Participants undergo PCNL followed by intrarenal instillation of dioxidine to prevent infection-related stone recurrence. Receives: Drug: Dioxidine; Procedure: Percutaneous Nephrolithotripsy (PCNL) |
| Standard Treatment Group | Active comparator | Participants undergo standard PCNL without adjunctive dioxidine. Receives: Procedure: Percutaneous Nephrolithotripsy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-PCNL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to receive standard PCNL with or without adjunctive intrarenal dioxidine instillation.
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Kazakhstan Marat Ospanov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talgat A. Imzharov, West Kazakhstan Marat Ospanov Medical University
- Investigators
- Bazylbek S Zhakiev, MD, Study director, West Kazakhstan Marat Ospanov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393711
- Sponsor's protocol ID
- Approval No. 11 (11.16/03)
- Other IDs
- EC Approval 11-16/03
- Acronym
- DIOX-PCNL
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Intrarenal Dioxidine Metaphylaxis for Preventing Recurrence of Infection Stones After Percutaneous Nephrolithotripsy
- ClinicalTrials.gov ID
- NCT07393711
- Acronym / sponsor ID
- DIOX-PCNL / Approval No. 11 (11.16/03)
- Conditions
- Kidney Calculi, Nephrolithiasis, Urinary Tract Infections
- Keywords
- Percutaneous nephrolithotomy, PCNL, Infection stones, Struvite stones, Dioxidine, Intrarenal instillation, Stone recurrence, Metaphylaxis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- West Kazakhstan Marat Ospanov Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to receive standard PCNL with or without adjunctive intrarenal dioxidine instillation.
| Arm | Type | Receives |
|---|---|---|
| Intrarenal Dioxidine Group | Experimental | Drug: Dioxidine, Procedure: Percutaneous Nephrolithotripsy (PCNL)Participants undergo PCNL followed by intrarenal instillation of dioxidine to prevent infection-related stone recurrence. |
| Standard Treatment Group | Active comparator | Procedure: Percutaneous Nephrolithotripsy (PCNL)Participants undergo standard PCNL without adjunctive dioxidine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Patients undergoing percutaneous nephrolithotripsy (PCNL)
- Infection-related kidney stones
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Age <18 years
- Pregnancy or breastfeeding
- Known hypersensitivity to dioxidine
- Severe renal insufficiency or end-stage renal disease
- Severe comorbid conditions that preclude participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DioxidineAlso: Intrarenal Dioxidine Instillation, Dioxidine SolutionIntrarenal instillation of dioxidine solution after PCNL to reduce bacterial colonization and prevent recurrence of infection-related stones. | Drug | Intrarenal Dioxidine Group |
| Percutaneous Nephrolithotripsy (PCNL)Also: PCNL, Percutaneous Stone Removal, Percutaneous LithotripsyStandard percutaneous nephrolithotripsy procedure for removal of kidney stones. | Procedure or surgery | Intrarenal Dioxidine Group, Standard Treatment Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Kidney Calculi
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bazylbek S Zhakiev, MD study director
West Kazakhstan Marat Ospanov Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dioxidine and Percutaneous Nephrolithotripsy (PCNL) in people with Kidney Calculi and Nephrolithiasis, run by West Kazakhstan Marat Ospanov Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Talgat A Imzharov (+77054442410, t.imzharov@zkmu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of infection-related kidney stones (time frame: 12 months post-PCNL). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.