UrolithiasisNCT07246967
Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
A study testing not use any prophylactic antimicrobials and use prophylactic antimicrobials in people with Urolithiasis and Antibiotics, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urolithiasis, Antibiotics
- What is being tested?
- not use any prophylactic antimicrobials and use prophylactic antimicrobials
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to Dec 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
- Scheduled to undergo fURS lithotripsy.
- No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
- No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
- No use of long-acting antimicrobial agents within 7 days prior to surgery, and no use of intermediate or short-acting antimicrobial agents within 72 hours prior to surgery.
- Has signed and dated an informed consent form, indicating that the patient or their legal representative has been fully informed about the study-related information and has agreed to participate.
Who cannot join
- Pregnant or lactating women.
- Allergy to the investigational drug(s).
- Participation in other clinical trials within 30 days.
- Presence of other active infection foci requiring antimicrobial treatment.
- Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
- Congenital malformations of the urinary tract.
Show all 18Show fewer
- History of kidney transplantation or urinary diversion surgery.
- Unable to provide samples or complete follow-up according to the study protocol.
- Unable to provide informed consent.
- Inability to achieve complete placement of the flexible negative-pressure suction sheath.
- Any other conditions that the investigator deems unsuitable for participation in this study.
- History of diabetes mellitus, immunocompromised.
- Renal insufficiency, neurogenic bladder.
- Recent preoperative history of stone-related fever.
- Long-term indwelling urinary drainage tube.
- Urine white blood cells >5/HPF (High Power Field) or positive for urine nitrites.
- Large stone burden (e.g., staghorn calculus) or moderate to severe hydronephrosis.
- Imaging findings showing turbid urine in the renal pelvis where pyonephrosis or infectious stones cannot be excluded.
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
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Yi Shao, Doctor, 13661633372 ext. 86, drshaoyi@163.com
About this study
Official title: An International Multicenter Study on the Antimicrobial Prophylaxis Strategy for Flexible Ureteroscopic Lithotripsy Combined With a Flexible Negative Pressure Suction Sheath
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
Read the detailed description
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
This trial is an international, multicenter, prospective, randomized controlled trial. The participating centers are: Shanghai General Hospital (lead institution), Shanghai Xinhua Hospital, Weifang Traditional Chinese Medicine Hospital, School of Medicine, Mulawarman University Abdul Wahab Sjahranie Hospital (Indonesia), and Hospital Raja Perempuan Zainab II (Malaysia).
This trial will employ a non-inferiority design and a central randomization system to allocate eligible subjects in a 1:1 ratio to either the experimental group (no prophylactic antimicrobials) or the control group (single-dose antimicrobial prophylaxis). Stratification factors will include the participating center and stone size, with subjects stratified by the longest stone diameter: ≤1.5cm and >1.5cm but ≤2cm.
All surgeries will be performed by surgeons with experience of ≥50 cases of flexible negative-pressure sheath procedures, using a standardized surgical record form to document key operational parameters (e.g., sheath model, negative pressure settings, operative time, irrigation volume, etc.). Prior to study initiation, all centers will undergo standardized surgical video training and simulated operational assessments to ensure technical consistency.
The surgery will follow standardized technical parameters: a F10/12, F11/13, or F12/14 flexible negative-pressure sheath will be selected based on the patient's ureteral conditions; the central negative pressure will be set to 0.02-0.04MPa; the irrigation flow rate will be 50-150 ml/min, adjusted to the minimum rate that both maintains collecting system filling and ensures low intrarenal pressure; and the lithotripsy will employ a 'simultaneous fragmentation and suction for in-situ stone clearance' strategy.
The study subjects will be patients with a low risk of infection (defined as no preoperative symptoms of infection such as chills and fever, a negative urine culture, and a stone size ≤2cm) from multiple centers who are scheduled to undergo single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. They will be allocated in a 1:1 ratio to the experimental group or the control group. The experimental group will undergo surgery without the use of any prophylactic antimicrobials; therapeutic antimicrobials will only be administered postoperatively to patients who develop signs or symptoms of infection. The control group will receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery, followed by the same standardized surgical procedure.
- Conditions
- Urolithiasis, Antibiotics
- Being tested
- not use any prophylactic antimicrobials, use prophylactic antimicrobials
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not use any prophylactic antimicrobialsDrug
Also called without the use of any antimicrobial drugs for prophylaxis
The experimental group will undergo surgery without the use of any prophylactic antimicrobials; therapeutic antimicrobials will only be administered postoperatively to patients who develop signs or symptoms of infection. The control group will receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery, followed by the same standardized surgical procedure.
use prophylactic antimicrobialsDrug
Also called apply antimicrobial drugs for prophylaxis
Receive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Undergo flexible ureteroscopic lithotripsy and stone clearance with a flexible negative-pressure sheath without the use of any prophylactic antimicrobials; postoperatively, therapeutic antimicrobials will be initiated only for patients who develop signs or symptoms of infection. Receives: Drug: not use any prophylactic antimicrobials |
| Group 2 | Active comparator | Receive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery. Receives: Drug: use prophylactic antimicrobials |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively
To reduce the influence of subjective factors and to more comprehensively reflect the systemic inflammatory state, the primary endpoint is the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively, defined as meeting at least two of the following criteria:
Body temperature >38°C or <36°C Heart rate >90 beats/minute Respiratory rate >20 breaths/minute or PaCO2 <32 mmHg White blood cell count >12×10⁹/L or <4×10⁹/L, or >10% immature neutrophils
Measured: within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (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.
- 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
- 500 participants (estimated)
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
- Investigators
- Yi Shao, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246967
- Sponsor's protocol ID
- IIT2025-208
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter Study on the Antimicrobial Prophylaxis Strategy for Flexible Ureteroscopic Lithotripsy Combined With a Flexible Negative Pressure Suction Sheath
- ClinicalTrials.gov ID
- NCT07246967
- Acronym / sponsor ID
- IIT2025-208
- Conditions
- Urolithiasis, Antibiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Nov 2025 (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.
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
Detailed description
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
This trial is an international, multicenter, prospective, randomized controlled trial. The participating centers are: Shanghai General Hospital (lead institution), Shanghai Xinhua Hospital, Weifang Traditional Chinese Medicine Hospital, School of Medicine, Mulawarman University Abdul Wahab Sjahranie Hospital (Indonesia), and Hospital Raja Perempuan Zainab II (Malaysia).
This trial will employ a non-inferiority design and a central randomization system to allocate eligible subjects in a 1:1 ratio to either the experimental group (no prophylactic antimicrobials) or the control group (single-dose antimicrobial prophylaxis). Stratification factors will include the participating center and stone size, with subjects stratified by the longest stone diameter: ≤1.5cm and >1.5cm but ≤2cm.
All surgeries will be performed by surgeons with experience of ≥50 cases of flexible negative-pressure sheath procedures, using a standardized surgical record form to document key operational parameters (e.g., sheath model, negative pressure settings, operative time, irrigation volume, etc.). Prior to study initiation, all centers will undergo standardized surgical video training and simulated operational assessments to ensure technical consistency.
The surgery will follow standardized technical parameters: a F10/12, F11/13, or F12/14 flexible negative-pressure sheath will be selected based on the patient's ureteral conditions; the central negative pressure will be set to 0.02-0.04MPa; the irrigation flow rate will be 50-150 ml/min, adjusted to the minimum rate that both maintains collecting system filling and ensures low intrarenal pressure; and the lithotripsy will employ a 'simultaneous fragmentation and suction for in-situ stone clearance' strategy.
The study subjects will be patients with a low risk of infection (defined as no preoperative symptoms of infection such as chills and fever, a negative urine culture, and a stone size ≤2cm) from multiple centers who are scheduled to undergo single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. They will be allocated in a 1:1 ratio to the experimental group or the control group. The experimental group will undergo surgery without the use of any prophylactic antimicrobials; therapeutic antimicrobials will only be administered postoperatively to patients who develop signs or symptoms of infection. The control group will receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery, followed by the same standardized surgical procedure.
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 | Experimental | Drug: not use any prophylactic antimicrobialsUndergo flexible ureteroscopic lithotripsy and stone clearance with a flexible negative-pressure sheath without the use of any prophylactic antimicrobials; postoperatively, therapeutic antimicrobials will be initiated only for patients who develop signs or symptoms of infection. |
| Group 2 | Active comparator | Drug: use prophylactic antimicrobialsReceive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years.
- Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
- Scheduled to undergo fURS lithotripsy.
- No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
- No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
Key exclusion criteria (18 listed)
- Pregnant or lactating women.
- Allergy to the investigational drug(s).
- Participation in other clinical trials within 30 days.
- Presence of other active infection foci requiring antimicrobial treatment.
- Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
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 |
|---|---|---|
| not use any prophylactic antimicrobialsAlso: without the use of any antimicrobial drugs for prophylaxisThe experimental group will undergo surgery without the use of any prophylactic antimicrobials; therapeutic antimicrobials will only be administered postoperatively to patients who develop signs or symptoms of infection. The control group will receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery, followed by the same standardized surgical procedure. | Drug | Group 1 |
| use prophylactic antimicrobialsAlso: apply antimicrobial drugs for prophylaxisReceive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery. | Drug | Group 2 |
Primary outcome
the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively
Time frame: within 72 hours postoperatively
To reduce the influence of subjective factors and to more comprehensively reflect the systemic inflammatory state, the primary endpoint is the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively, defined as meeting at least two of the following criteria: Body temperature >38°C or <36°C Heart rate >90 beats/minute Respiratory rate >20 breaths/minute or PaCO2 <32 mmHg White blood cell count >12×10⁹/L or <4×10⁹/L, or >10% immature neutrophils
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 23 Apr 2026.
- 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.
Yi Shao principal investigator
Shanghai General Hospital, Shanghai Jiao Tong 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 not use any prophylactic antimicrobials and use prophylactic antimicrobials in people with Urolithiasis and Antibiotics, 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 7 inclusion and 18 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 23 Apr 2026. 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 Ziyang Zheng (18861968196 ext. +86, zhengzzy0116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively (time frame: within 72 hours postoperatively). 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 23 Apr 2026.