Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter: a Multicenter, Randomized, Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urolithiasis
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Pain score
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Yi Shao
Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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 1. Mild urgency 2. Moderate urgency 3. Severe urgency 4. Urge incontinence
Secondary Outcomes
- Painful Memory(1 month after surgery)
- Operation time(The end of operation)
- blood routine(Before surgery and 4 hours after surgery)