Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter

Shanghai Jiao Tong University

Status: Completed

Conditions: Urolithiasis; Catheter-related Bladder Discomfort

Treatments: Procedure: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter; Procedure: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06458101

IIT2024-050

Details and patient eligibility

About

A prospective, multicenter, randomized, controlled clinical trial was conducted to compare the efficacy and safety of non-indwelling catheter and indwelling catheter in relieving postoperative catheter-related complications after ureteroscopic lithotripsy. By comparing the pain score and urination urgency score (PPIUS) of patients after ureteroscopic lithotripsy (including flexible ureteroscopy) lithotripsy to provide a reliable scientific basis for indwelling catheter after ureteroscopic lithotripsy.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with upper urinary tract calculi undergoing rigid ureteroscopic and soft ureteroscopic lithotripsy;
• Normal renal function;
• Aged between 18 and 70 years old
• Complete the operation under general anesthesia

Exclusion criteria

• Solitary kidney;
• Previous history of renal transplantation or urinary diversion;
• Congenital malformation of urinary system;
• Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.
• Severe heart or lung disease, Malignant tumor and immunodeficiency state
• Urethral stricture
• Neurogenic bladder
• Operation under epidural anesthesia or spinal anesthesia
• Large amount of bleeding during operation should be observed by indwelling catheter to observe urine color
• High risk factors such as large amount of pus fur should be observed during operation.
• Urethral injury during operation leads to false passage
• Operation time is more than 90 minutes. Higher risk of bleeding or infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Active Comparator group

Description:

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Treatment:

Procedure: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Group 2: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Experimental group

Description:

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Treatment:

Procedure: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter