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

Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter: a Multicenter, Randomized, Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis; Catheter-related Bladder Discomfort
• Intervention / Treatment: Procedure: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter; Procedure: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter; Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter	Procedure: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter; Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter
Experimental: Group 2: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter; Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter	Procedure: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter; Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	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.	4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
Urinary urgency score	urinary urgency score will be measured by PPIUS scale. 0 No urgency; Mild urgency; Moderate urgency; Severe urgency; Urge incontinence	4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Painful Memory	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	1 month after surgery
Operation time	Operation time	The end of operation
blood routine	To calculate the change of haemoglobin	Before surgery and 4 hours after surgery

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 9, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Urologic Surgical Procedures; Urogenital Surgical Procedures; Diagnostic Techniques, Urological; Ultrasonic Surgical Procedures; Ureteroscopy; Lithotripsy
• Other Study ID Numbers: IIT2024-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the trial is completed, it is shared on the network platform: China Clinical trial Registration Center; website: http://www.chictr.org.cn
• IPD Sharing Time Frame: After the trial is completed,
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No