Bladder Catheterization After Mini-PCNL

November 8, 2021 updated by: St. Petersburg State Pavlov Medical University

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation, 197342
        • Recruiting
        • First Pavlov Saint Petersburg University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: No Catheterization
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
Installation of Foley catheter into the urinary bladder
ACTIVE_COMPARATOR: Catheterization
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
Installation of Foley catheter into the urinary bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the level of pain in patients
Time Frame: 1 day
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
Time Frame: 1 day
Performing ultrasound examination of urinary bladder after PCNL,
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Petersburg State Pavlov Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (ACTUAL)

September 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/20-н

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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