Bladder Catheterization After Mini-PCNL

St. Petersburg State Pavlov Medical University

Status: Unknown

Conditions: Urolithiasis

Treatments: Procedure: Urinary bladder catheterisation

Study type: Interventional

Funder types: Other

Identifiers

NCT04570787

04/20-н

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

No Catheterization

Active Comparator group

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.

Treatment:

Procedure: Urinary bladder catheterisation

Catheterization

Active Comparator group

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.

Treatment:

Procedure: Urinary bladder catheterisation