UrolithiasisNCT06569173
Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
A study testing LaiKai anti-reflux ureteral stent and LaiKai Ureteral Stent in people with Urolithiasis and Child, Only, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Urolithiasis, Child, Only
- What is being tested?
- LaiKai anti-reflux ureteral stent and LaiKai Ureteral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2024to 23 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A definitive diagnosis of urinary tract stones by CT scan, with indications for ureteroscopic lithotripsy (URL), percutaneous nephrolithotomy (PCNL), laparoscopic/open stone extraction with or without robotic assistance, or combined endoscopic lithotripsy, and no contraindications;
- Age is less than 18 years old;
- For preschool children, the informed consent form is signed by the parents; for school-age children, the informed consent form is signed by both the parents and the child themselves.
Who cannot join
- A history of recurrent bladder irritative symptoms or urinary tract infections;
- Severe renal insufficiency, anatomical or functional solitary kidney, and other significant comorbidities that render the child unsuitable for participation in the study;
- Stent placement surgery within the past 3 months;
- Recent use of medications that may interfere with the study results, such as solifenacin;
- Stent removal surgery performed at an external medical facility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Hongbo Liu, +86 19329110160, 19329110160@zju.edu.cn
About this study
Official title: Comparison of the Drainage/Anti-reflux Effect and Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.
Read the detailed description
Ureteral stents are crucial adjunctive devices following urolithiasis surgery, serving to support the ureter and facilitate urine drainage. However, the application of these stents can lead to complications such as urinary tract infections, lumbar pain, and bladder irritative symptoms, which significantly impact the quality of life in pediatric patients. Novel designs, such as anti-reflux stents equipped with valves, have been optimized to enhance unidirectional urine flow while effectively preventing retrograde urine flow. It is anticipated that these designs could alleviate symptoms of lumbar pain and urinary tract infections, thereby improving the postoperative recovery quality in children. Current adult studies suggest that anti-reflux stents might reduce urine reflux but may also be associated with significantly stronger urinary symptoms. To date, there have been no pediatric studies reported on the efficacy of anti-reflux stents. The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.
- Conditions
- Urolithiasis, Child, Only
- Being tested
- LaiKai anti-reflux ureteral stent, LaiKai Ureteral Stent
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaiKai anti-reflux ureteral stentDevice
Ureteral stents are serving to support the ureter and facilitate urine drainage with an anti-reflux valve.
LaiKai Ureteral StentDevice
Ureteral stents are serving to support the ureter and facilitate urine drainage.
| Study group | Role | What they receive |
|---|---|---|
| LaiKai Anti-Reflux Ureteral Stent (19903) | Experimental | LaiKai Anti-Reflux Ureteral Stent (19903) arm received anti-reflux stent. Receives: Device: LaiKai anti-reflux ureteral stent |
| LaiKai Ureteral Stent (92001024) | Active comparator | LaiKai Ureteral Stent (92001024) arm received regular ureteral stent. Receives: Device: LaiKai Ureteral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of stents on body pain
Inquire whether the child has experienced body pain, especially lumbar pain after the insert or removal of the stent. If yes, assign a value of 1; if no, assign a value of 0. The higher the score, the worse the stent is in terms of relieving lumbar pain.
Measured: Two weeks after stents inserting and two weeks after stents removing
Secondary outcomes (5)
The effect of stents on stone-free rate
Calculate the stone clearance rate for children three months and half a year after surgery. The higher the stone clearance rate, the better the stent's effectiveness.
Measured: Two weeks after stents inserting and two weeks after stents removing
The effect of stents on urinary symptoms
Use a self-administered questionnaire to understand the children's daytime urination intervals, times getting up at night, number of urge urinary incontinence episodes, number of genuine urinary incontinence episodes, times of incomplete urination, times of burning sensation during urination, number of hematuria episodes, degree of hematuria, and overall impact of urinary tract symptoms. Scores are assigned from 1 to 3 or 1 to 5 for different questions, with higher scores indicating poorer stent effectiveness in the corresponding dimension.
Measured: Two weeks after stents inserting and two weeks after stents removing
The effect of stents on daily activities and psychological well-being
Based on the questions in the self-administered questionnaire, including "Does the stent affect daily activities?", "Does the stent affect the child's social interactions?", and "Does the stent cause the child to have feelings of inferiority?", we understand the impact of the stent on the child's daily life and psychological well-being. The results are categorized as "No impact", "Slight impact", and "Significant impact", with corresponding scores of "1-3 points". The higher the score, the greater the adverse effect of the stent on the child.
Measured: Two weeks after stents inserting and two weeks after stents removing
The effect of stents on clinical presentation
Understand the impact of the stent on children's urinary tract infections, antibiotic use, and emergency department visits through a questionnaire. The results are scored as "0-1" or "1-5", with higher scores indicating a greater adverse effect of the stent.
Measured: Two weeks after stents inserting and two weeks after stents removing
The effect of the stent on learning
Understand the impact of the stent on the child's learning situation through a questionnaire, with the results scored on a scale of "0-1". The higher the score, the greater the adverse impact of the stent on learning.
Measured: Two weeks after stents inserting and two weeks after stents removing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start23 Aug 2024
- Primary completion23 Aug 2025 (estimated)
- Study completion23 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbo Liu, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Hongbo Liu, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569173
- Sponsor's protocol ID
- 2024-IRB-0212-IR-01
- Status last verified
- Nov 2024
- First submitted
- 23 Jul 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu Q, Liu H, Ru W, Xu Z, Hu L, Yan X. Does an anti-reflux ureteral stent offer real benefits for children after endoscopic surgery for upper urinary tract stones? A single-center randomized controlled trial. World J Urol. 2026 Jun 6;44(1):412. doi: 10.1007/s00345-026-06525-8.
PubMed 42249895
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Drainage/Anti-reflux Effect and Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
- ClinicalTrials.gov ID
- NCT06569173
- Acronym / sponsor ID
- 2024-IRB-0212-IR-01
- Conditions
- Urolithiasis, Child, Only
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 23 Aug 2025 (estimated)
- Study completion
- 23 Aug 2025 (estimated)
- First posted
- 23 Aug 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.
The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.
Detailed description
Ureteral stents are crucial adjunctive devices following urolithiasis surgery, serving to support the ureter and facilitate urine drainage. However, the application of these stents can lead to complications such as urinary tract infections, lumbar pain, and bladder irritative symptoms, which significantly impact the quality of life in pediatric patients. Novel designs, such as anti-reflux stents equipped with valves, have been optimized to enhance unidirectional urine flow while effectively preventing retrograde urine flow. It is anticipated that these designs could alleviate symptoms of lumbar pain and urinary tract infections, thereby improving the postoperative recovery quality in children. Current adult studies suggest that anti-reflux stents might reduce urine reflux but may also be associated with significantly stronger urinary symptoms. To date, there have been no pediatric studies reported on the efficacy of anti-reflux stents. The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LaiKai Anti-Reflux Ureteral Stent (19903) | Experimental | Device: LaiKai anti-reflux ureteral stentLaiKai Anti-Reflux Ureteral Stent (19903) arm received anti-reflux stent. |
| LaiKai Ureteral Stent (92001024) | Active comparator | Device: LaiKai Ureteral StentLaiKai Ureteral Stent (92001024) arm received regular ureteral stent. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- A definitive diagnosis of urinary tract stones by CT scan, with indications for ureteroscopic lithotripsy (URL), percutaneous nephrolithotomy (PCNL), laparoscopic/open stone extraction with or without robotic assistance, or combined endoscopic lithotripsy, and no contraindications;
- Age is less than 18 years old;
- For preschool children, the informed consent form is signed by the parents; for school-age children, the informed consent form is signed by both the parents and the child themselves.
Key exclusion criteria (5 listed)
- A history of recurrent bladder irritative symptoms or urinary tract infections;
- Severe renal insufficiency, anatomical or functional solitary kidney, and other significant comorbidities that render the child unsuitable for participation in the study;
- Stent placement surgery within the past 3 months;
- Recent use of medications that may interfere with the study results, such as solifenacin;
- Stent removal surgery performed at an external medical facility.
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 |
|---|---|---|
| LaiKai anti-reflux ureteral stentUreteral stents are serving to support the ureter and facilitate urine drainage with an anti-reflux valve. | Device | LaiKai Anti-Reflux Ureteral Stent (19903) |
| LaiKai Ureteral StentUreteral stents are serving to support the ureter and facilitate urine drainage. | Device | LaiKai Ureteral Stent (92001024) |
Primary outcome
The effect of stents on body pain
Time frame: Two weeks after stents inserting and two weeks after stents removing
Inquire whether the child has experienced body pain, especially lumbar pain after the insert or removal of the stent. If yes, assign a value of 1; if no, assign a value of 0. The higher the score, the worse the stent is in terms of relieving lumbar pain.
5 secondary outcomes
The effect of stents on stone-free rate
Time frame: Two weeks after stents inserting and two weeks after stents removing
The effect of stents on urinary symptoms
Time frame: Two weeks after stents inserting and two weeks after stents removing
The effect of stents on daily activities and psychological well-being
Time frame: Two weeks after stents inserting and two weeks after stents removing
The effect of stents on clinical presentation
Time frame: Two weeks after stents inserting and two weeks after stents removing
The effect of the stent on learning
Time frame: Two weeks after stents inserting and two weeks after stents removing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 42249895Hu Q, Liu H, Ru W, Xu Z, Hu L, Yan X. Does an anti-reflux ureteral stent offer real benefits for children after endoscopic surgery for upper urinary tract stones? A single-center randomized controlled trial. World J Urol. 2026 Jun 6;44(1):412. doi: 10.1007/s00345-026-06525-8.
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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.
Hongbo Liu principal investigator
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LaiKai anti-reflux ureteral stent and LaiKai Ureteral Stent in people with Urolithiasis and Child, Only, run by The Children's Hospital of Zhejiang 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimei Ma (+86 15888864134, maaimei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of stents on body pain (time frame: Two weeks after stents inserting and two weeks after stents removing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06569173, which also lists 1 linked publication.
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 12 Nov 2024.