Bladder Catheterization After Mini-PCNL
Single-center Randomized Study Evaluating Feasibility of Routine Bladder Catheterization After Mini- Percutaneous Nephrolithotripsy (PCNL)
1 other identifier
interventional
60
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedNovember 9, 2021
November 1, 2021
1.6 years
August 5, 2020
November 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To register the AE regarding catheterization or absence of catheterization
1 day
Study Arms (2)
No Catheterization
ACTIVE COMPARATORAfter 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
ACTIVE COMPARATORAfter 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.
Interventions
Installation of Foley catheter into the urinary bladder
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active urinary tract infection
- Coagulopathy
- Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Pavlov Saint Petersburg University
Saint Petersburg, 197342, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2020
First Posted
September 30, 2020
Study Start
July 1, 2020
Primary Completion
February 1, 2022
Study Completion
April 1, 2022
Last Updated
November 9, 2021
Record last verified: 2021-11