UrolithiasisNCT06458101
Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter
A study testing Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter and Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter in people with Urolithiasis and Catheter-related Bladder Discomfort, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urolithiasis, Catheter-related Bladder Discomfort
- What is being tested?
- Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter and Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter: a Multicenter, Randomized, Controlled Study
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.
- Conditions
- Urolithiasis, Catheter-related Bladder Discomfort
- Being tested
- Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter, Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheterProcedure or surgery
Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter
Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheterProcedure or surgery
Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter | Active comparator | Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter Receives: Procedure: 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 Receives: Procedure: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- Mild urgency
- Moderate urgency
- Severe urgency
- Urge incontinence
Measured: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
Secondary outcomes (3)
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
Measured: 1 month after surgery
Operation time
Operation time
Measured: The end of operation
blood routine
To calculate the change of haemoglobin
Measured: Before surgery and 4 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Shao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458101
- Sponsor's protocol ID
- IIT2024-050
- Status last verified
- Nov 2025
- First submitted
- 3 Jun 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the trial is completed, it is shared on the network platform: China Clinical trial Registration Center; website: http://www.chictr.org.cn
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter: a Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06458101
- Acronym / sponsor ID
- IIT2024-050
- Conditions
- Urolithiasis, Catheter-related Bladder Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter | Active comparator | Procedure: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheterUreteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter |
| Group 2: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter | Experimental | Procedure: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheterUreteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheterUreteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter | Procedure or surgery | Group 2: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter |
| Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheterUreteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter | Procedure or surgery | Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter |
Primary outcome
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
3 secondary outcomes
Painful Memory
Time frame: 1 month after surgery
Operation time
Time frame: The end of operation
blood routine
Time frame: Before surgery and 4 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes. After the trial is completed, it is shared on the network platform: China Clinical trial Registration Center; website: http://www.chictr.org.cn
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter and Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter in people with Urolithiasis and Catheter-related Bladder Discomfort, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.