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Completed

NCT Number: NCT06458101

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

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.

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Key information

Conditions

Urolithiasis Catheter-related Bladder Discomfort Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Procedure

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

Primary outcomes

  1. Pain score

    Time frame: 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.

  2. Urinary urgency score

    Time frame: 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

    • Mild urgency
    • Moderate urgency
    • Severe urgency
    • Urge incontinence

Secondary outcomes

  1. Painful Memory

    Time frame: 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

  2. Operation time

    Time frame: The end of operation

    Operation time

  3. blood routine

    Time frame: Before surgery and 4 hours after surgery

    To calculate the change of haemoglobin

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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