Bladder Catheterization After Mini-PCNL

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04570787

Enrollment

Registered

2020-09-30

Start date

2020-07-01

Completion date

2022-04-01

Last updated

2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Keywords

Urolithiasis, PCNL, Bladder catheterisation

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.

Interventions

PROCEDUREUrinary bladder catheterisation

Installation of Foley catheter into the urinary bladder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Russia

Contacts

Primary ContactDmitry S Gorelov

dsgorelov@mail.ru+79217964892

Backup ContactVladimir M Obidniak

v.obidniak@gmail.com+79218944746

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026