Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwel… (NCT06458101) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter
China180 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain score
Timeframe: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
2
Urinary urgency score
Timeframe: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
Trial details
NCT IDNCT06458101
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine