Bladder Catheterization After Mini-PCNL

Study Overview
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Brief Summary
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60 patients Inclusion Criteria: age from 18 to 70 years Indications for mini-PCNL ASA score: 1-3 Single percutaneous access to pyelocaliceal system Size of solitary calculus up to 2.5 cm Exclusion Criteria: Active urinary tract infection Coagulopathy Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)

Detailed Description
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60 patients after PCNL will be recruited and randomized into 2 groups (30 vs 30): No Catheterization after mini-PCNL (study) - the bladder catheterization is not performed. Catheterization after mini-PCNL (control) - the bladder will be drained with the urethral catheter. All patients will fill out the VASP in 2, 6, 12, 24 hours after mini-PCNL. Ultrasound examination of urinary bladder will be performed after mini-PCNL. All the AE will be registered.

Official Title
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Single-center Randomized Study Evaluating Feasibility of Routine Bladder Catheterization After Mini- Percutaneous Nephrolithotripsy (PCNL)

Conditions
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Urolithiasis

Intervention / Treatment
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* Procedure: Urinary bladder catheterisation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 70 years Indications for mini-PCNL ASA score: 1-3 Single percutaneous access to pyelocaliceal system Size of solitary stone up to 2.5 cm Exclusion Criteria: Active urinary tract infection Coagulopathy Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Catheterization<br>After mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. Bladder catheterization is not performed. | Procedure: Urinary bladder catheterisation<br>* Installation of Foley catheter into the urinary bladder<br>|
| Active Comparator: Catheterization<br>After mini-PCNL standardized follow-up protocol supposes drainage the upper urinary tract with nephrostomy, tubeless (using ureteral stent without nephrostomy) or totally tubeless (no drainage) tactics. The bladder is to be drained with the urethral catheter in all cases. | Procedure: Urinary bladder catheterisation<br>* Installation of Foley catheter into the urinary bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the level of pain in patients | Filling out the VASP score after PCNL by all patients in 2, 6, 12 and 24 hours | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To register the AE regarding catheterization or absence of catheterization | Performing ultrasound examination of urinary bladder after PCNL, | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urolithiasis, PCNL, Bladder catheterisation