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Bladder Catheterization After Mini-PCNL

Primary Purpose

Urolithiasis

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Urinary bladder catheterisation
Sponsored by
St. Petersburg State Pavlov Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring Urolithiasis, PCNL, Bladder catheterisation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • First Pavlov Saint Petersburg UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No Catheterization

Catheterization

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To register the AE regarding catheterization or absence of catheterization
Performing ultrasound examination of urinary bladder after PCNL,

Full Information

First Posted
August 5, 2020
Last Updated
November 8, 2021
Sponsor
St. Petersburg State Pavlov Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04570787
Brief Title
Bladder Catheterization After Mini-PCNL
Official Title
Single-center Randomized Study Evaluating Feasibility of Routine Bladder Catheterization After Mini- Percutaneous Nephrolithotripsy (PCNL)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg State Pavlov Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Urolithiasis, PCNL, Bladder catheterisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Catheterization
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Catheterization
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Urinary bladder catheterisation
Intervention Description
Installation of Foley catheter into the urinary bladder
Primary Outcome Measure Information:
Title
To measure the level of pain in patients
Description
Filling out the VASP score after PCNL by all patients in 2, 6, 12 and 24 hours
Time Frame
1 day
Secondary Outcome Measure Information:
Title
To register the AE regarding catheterization or absence of catheterization
Description
Performing ultrasound examination of urinary bladder after PCNL,
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry S Gorelov
Phone
+79217964892
Email
dsgorelov@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir M Obidniak
Phone
+79218944746
Email
v.obidniak@gmail.com
Facility Information:
Facility Name
First Pavlov Saint Petersburg University
City
Saint Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitriy Gorelov, MD
Phone
+79217964892
Email
dsgorelov@mail.ru

12. IPD Sharing Statement

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Bladder Catheterization After Mini-PCNL

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