UrolithiasisNCT04858750
Comparison and Evaluation of USSQ, OABSS, and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J Stents in Patients Who Underwent URL
A study testing Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy in people with Urolithiasis and Overactive Bladder Syndrome, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis, Overactive Bladder Syndrome
- What is being tested?
- Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 May 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal CT scanning indicating ureteral stones or kidney stones that are less than 2 cm in diameter, and patients who are planning to undergo URL surgery.
- Age between 18 and 80 years old and capable of providing written informed consent;
- In general, the heart, lung, liver and kidney function are in well condition, able to tolerate surgical treatment, and comply with research requirements.
Who cannot join
- Before the onset of urolithiasis, the patient has suffered from obvious overactive bladder syndrome, or chronic lower urinary tract infection, or urinary anatomic deformities, or had previously undergone urinary tract plastic surgery.
- Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
- The patient is not a local resident and insists on returning to his howetown for D-J stent removal after the URL operation（so that we are unable to retrieve the D-J stent and conduct the in vitro experiment）.
- The patient refuses to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Jie NA Ding, M.D., 86-13564315425, dingjie@xinhuamed.com.cn
Lin Zhang, M.D.
About this study
Official title: Comparison and Evaluation of USSQ (Ureteral Stent Symptom Questionnaire）, OABSS (Overactive Bladder Symptom Score), and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J（Double-J) Stents in Patients Who Underwent URL (Ureteroscopic Holmium Laser Lithotripsy）
Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire）scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.
- Conditions
- Urolithiasis, Overactive Bladder Syndrome
- Being tested
- Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy
- Keywords
- USSQ, OABSS, double-J stent, ureteroscopic holmium laser lithotripsy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsyDevice
During ureteral holmium laser lithotripsy operation, after the stones were fragmented, the D-J stents of three different types were placed, the insertion process are exactly the same.
| Study group | Role | What they receive |
|---|---|---|
| Cook D-J stent group | Other | Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent.
Note: USI is an unexpandable acronym. Receives: Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy |
| KYB anti-reflux D-J stent group | Other | Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent. Receives: Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy |
| Urovision trigonal D-J stent group | Other | Patients randomized to this group received Urovision (Bad Aibling, Germany, ST-230726) trigonal D-J stent.
Note: ST is an unexpandable acronym. Aibling is a German region name. Receives: Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Measured: 1 week (after URL)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Measured: 1 week (after URL)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Measured: 4 weeks (before removal of D-J stent)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Measured: 4 weeks (before removal of D-J stent)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Measured: 5 weeks (1 week after removal of D-J stent)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Measured: 5 weeks (1 week after removal of D-J stent)
Secondary outcomes (2)
Drainage effect of D-J stents after being removed
The drainage effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
Measured: 4 weeks
Anti-reflux effect of D-J stents after being removed
The anti-reflux effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Feb 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858750
- Sponsor's protocol ID
- XHEC-C-2021-106-1
- Status last verified
- Feb 2022
- First submitted
- 14 Apr 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There might be other serial studies after this study, so we haven't decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison and Evaluation of USSQ (Ureteral Stent Symptom Questionnaire）, OABSS (Overactive Bladder Symptom Score), and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J（Double-J) Stents in Patients Who Underwent URL (Ureteroscopic Holmium Laser Lithotripsy）
- ClinicalTrials.gov ID
- NCT04858750
- Acronym / sponsor ID
- XHEC-C-2021-106-1
- Conditions
- Urolithiasis, Overactive Bladder Syndrome
- Keywords
- USSQ, OABSS, double-J stent, ureteroscopic holmium laser lithotripsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 26 Apr 2021 (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.
Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire）scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cook D-J stent group | Other | Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsyPatients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent. Note: USI is an unexpandable acronym. |
| KYB anti-reflux D-J stent group | Other | Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsyPatients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent. |
| Urovision trigonal D-J stent group | Other | Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsyPatients randomized to this group received Urovision (Bad Aibling, Germany, ST-230726) trigonal D-J stent. Note: ST is an unexpandable acronym. Aibling is a German region name. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Abdominal CT scanning indicating ureteral stones or kidney stones that are less than 2 cm in diameter, and patients who are planning to undergo URL surgery.
- Age between 18 and 80 years old and capable of providing written informed consent;
- In general, the heart, lung, liver and kidney function are in well condition, able to tolerate surgical treatment, and comply with research requirements.
Key exclusion criteria (4 listed)
- Before the onset of urolithiasis, the patient has suffered from obvious overactive bladder syndrome, or chronic lower urinary tract infection, or urinary anatomic deformities, or had previously undergone urinary tract plastic surgery.
- Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
- The patient is not a local resident and insists on returning to his howetown for D-J stent removal after the URL operation（so that we are unable to retrieve the D-J stent and conduct the in vitro experiment）.
- The patient refuses to sign the informed consent.
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 |
|---|---|---|
| Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsyDuring ureteral holmium laser lithotripsy operation, after the stones were fragmented, the D-J stents of three different types were placed, the insertion process are exactly the same. | Device | Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group |
Primary outcome
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time frame: 1 week (after URL)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time frame: 1 week (after URL)
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time frame: 4 weeks (before removal of D-J stent)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time frame: 4 weeks (before removal of D-J stent)
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time frame: 5 weeks (1 week after removal of D-J stent)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time frame: 5 weeks (1 week after removal of D-J stent)
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
2 secondary outcomes
Drainage effect of D-J stents after being removed
Time frame: 4 weeks
Anti-reflux effect of D-J stents after being removed
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided. There might be other serial studies after this study, so we haven't decided yet.
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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.
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy in people with Urolithiasis and Overactive Bladder Syndrome, run by Xinhua 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent (time frame: 1 week (after URL)). The study lists 6 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 22 Mar 2022.