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

NCT06458101 | Completed

• 1 other identifier: IIT2024-050
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Catheter-related Bladder Discomfort

Outcome Measures

Primary Outcomes (2)

• 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 1. Mild urgency 2. Moderate urgency 3. Severe urgency 4. Urge incontinence

  4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)

Secondary Outcomes (3)

• Painful Memory

  1 month after surgery

• Operation time

  The end of operation

• blood routine

  Before surgery and 4 hours after surgery

Study Arms (2)

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

ACTIVE COMPARATOR

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

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

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

EXPERIMENTAL

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

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

Interventions

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter PROCEDURE

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

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

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter PROCEDURE

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Ureteroscopy; Lithotripsy

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Therapeutics; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the trial is completed,

Locations

CN (1)