Bladder Catheterization After Mini-PCNL

Not Applicable

• Conditions: Urolithiasis
• Interventions: Procedure: Urinary bladder catheterisation

• Registration Number: NCT04570787
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-09
• Primary Completion: 2022-02-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Catheterization	Urinary bladder catheterisation	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.
Catheterization	Urinary bladder catheterisation	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.

Primary Outcome Measures

Name	Time	Method
To measure the level of pain in patients	1 day	Filling out the VASP score after PCNL by all patients in 2, 6, 12 and 24 hours

Secondary Outcome Measures

Name	Time	Method
To register the AE regarding catheterization or absence of catheterization	1 day	Performing ultrasound examination of urinary bladder after PCNL,

Trial Locations

Locations (1)

First Pavlov Saint Petersburg University; 🇷🇺 Saint Petersburg, Russian Federation