Bladder Catheterization After Mini-PCNL

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570787
• Other study ID #: 04/20-?
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: November 2021
• Source: St. Petersburg State Pavlov Medical University
• Contact: Dmitry S Gorelov
• Phone: +79217964892
• Email: dsgorelov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Urinary Calculi
• Urolithiasis

Intervention

Procedure:
• Urinary bladder catheterisation
Installation of Foley catheter into the urinary bladder

Locations

Country	Name	City	State
Russian Federation	First Pavlov Saint Petersburg University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To register the AE regarding catheterization or absence of catheterization	Performing ultrasound examination of urinary bladder after PCNL,	1 day