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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458101
• Other study ID #: IIT2024-050
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2024
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 172
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter-related Bladder Discomfort
• Urolithiasis

Intervention

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

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	Operation time	Operation time	The end of operation
Secondary	blood routine	To calculate the change of haemoglobin	Before surgery and 4 hours after surgery