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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter | Procedure | Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
After the trial is completed, it is shared on the network platform: China Clinical trial Registration Center; website: http://www.chictr.org.cn
After the trial is completed,
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| Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter | Procedure | Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter |
|
| 1 month after surgery |
| Operation time | Operation time | The end of operation |
| blood routine | To calculate the change of haemoglobin | Before surgery and 4 hours after surgery |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D018666 | Ureteroscopy |
| D008096 | Lithotripsy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013812 | Therapeutics |
| D059708 | Ultrasonic Surgical Procedures |
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