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

Not Applicable

Not yet recruiting

• Conditions: Catheter-related Bladder Discomfort; Urolithiasis
• Interventions: Procedure: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter; Procedure: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

• Registration Number: NCT06458101
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-09
• Study First Posted: 2024-06-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-12-09
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter	Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter	Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter
Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter	Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter	Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Primary Outcome Measures

Name	Time	Method
Pain score	4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)	pain scoring will be measured by VAS scale. There are 10 scales, with "0" and "10" at both ends. 0 indicates no pain and 10 represents the most severe pain that is unbearable.
Urinary urgency score	4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)	urinary urgency score will be measured by PPIUS scale. 0 No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urge incontinence

Secondary Outcome Measures

Name	Time	Method
Painful Memory	1 month after surgery	Painful memory will be measured by SUDS scale. 100: Unbearably upset to the point that you cannot function and may be on the verge of a breakdown 90: Extremely anxious and desperate; helpless and unable to handle it 80: Worried and panicky; losing focus and feeling anxious in your body 70: Discomfort dominates your thoughts and you struggle to function normally 60: Moderate to strong levels of discomfort 50: Upset and uncomfortable; still functional 40: Mild to moderate anxiety and worry 30: Worried or upset; still able to function 20: A little bit sad or distressed 10: No distress; alert and focused 0: Peaceful and complete calm
Operation time	The end of operation	Operation time
blood routine	Before surgery and 4 hours after surgery	To calculate the change of haemoglobin

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China