UTINCT07740811
Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
An observational study of UTI and Bacterial Colonization, run by Al-Azhar University at 1 site in Egypt.
Trial summary
To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- UTI, Bacterial Colonization
- What is being tested?
- Urine and stent cultures
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 May 2028
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal. At stent removal, the stent will be handled under sterile conditions and sent for culture. If possible, the proximal and distal stent segments will be cultured separately to assess concordance between device segments. Standard microbiological methods will be used to identify organisms and perform antimicrobial susceptibility testing. The main endpoint of microbiological assessment will be bacterial colonization of the stent, defined as significant growth from the stent culture regardless of urine culture status. If resources permit, biofilm analysis or sonication-based processing may be added to improve detection
Who may be able to join
- Patients undergoing temporary Double-J ureteral stent insertion.
- Stent inserted for a standard urological indication, including ureteric stone disease, ureteral obstruction, postoperative drainage, or ureteral injury repair.
- Planned stent removal during the study follow-up period.
- Availability for clinical follow-up and specimen collection at insertion and removal.
- Provision of written informed consent.
Who cannot join
- Active urosepsis at the time of stent insertion.
- Permanent or intended long-term stenting outside the study framework.
- Concomitant nephrostomy tube or urinary diversion that may confound microbiological results.
- Known severe immunosuppression or neutropenia if expected to substantially alter colonization risk.
- Patients with incomplete baseline clinical data.
- Patients lost to follow-up or whose stent could not be retrieved for microbiological analysis.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Fawzy Salman
Cairo
Mohamed Fawzy Salman, MD, 01111788996
Mohamed Fawzy salman, MD, 01111788996, prof_mohamed_fawzy@yahoo.com
About this study
To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.
Read the detailed description
Ureteral stents are indispensable in modern urology, but they are frequently complicated by bacterial colonization, biofilm formation, bacteriuria, and infectious morbidity.
Biofilm is clinically important because it promotes microbial persistence on the stent surface, reduces antimicrobial susceptibility, and may contribute to urinary tract infection (UTI) or even severe systemic infection in selected patients.
Prospective studies have shown that febrile ureteral stent-associated UTI occurs in a measurable proportion of patients and can progress to sepsis or septic shock in a subset.
More recent studies also confirm that colonization and resistance patterns vary by patient profile and stent dwell time.A major challenge in this field is that urine culture does not reliably exclude stent colonization.
Several studies have shown that a substantial proportion of patients with sterile urine still have colonized stents, meaning that urine testing alone may underestimate the burden of device-associated infection. In addition, the organisms recovered from stents are often more resistant than those isolated before stent insertion, which raises concern about delayed recognition and suboptimal empiric antibiotic choice in high-risk patients.
These findings support the need to study stent cultures and patient factors together rather than relying on urine culture alone.
The risk factors for bacterial colonization appear to be multifactorial, but the most consistently reported predictor is longer indwelling time. Other factors that have emerged across studies include diabetes mellitus, chronic kidney disease, pregnancy, prior urinary infection, prior catheterization, and albuminuria, although the strength of association is not uniform across all cohorts. Despite this, there is still limited prospective evidence integrating these predictors with clinical outcomes such as febrile UTI, symptom burden, and antimicrobial resistance.
Accordingly, we hypothesize that bacterial colonization of Double-J ureteral stents is associated with identifiable patient- and stent-related risk factors, especially prolonged indwelling time and metabolic or renal comorbidity, and that colonized stents are associated with clinically meaningful outcomes including bacteriuria, resistant organisms, and greater stent-related morbidity.
The significance of this study is that it may help refine patient counseling, improve timing of stent removal, and support targeted surveillance and antibiotic strategies in high-risk patients.
AIM OF THE STUDY To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.
- Conditions
- UTI, Bacterial Colonization
- Being tested
- Urine and stent cultures
- Keywords
- UTI, Bacterial colonization, JJ stent, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine and stent culturesDiagnostic test
All adult patients who undergo Double-J ureteral stent insertion for standard urological indications during the study period will be assessed for eligibility.
Patients will be followed until stent removal, and microbiological evaluation will be performed on both urine and stent specimens at the time of removal
| Study group | Role | What they receive |
|---|---|---|
| Patients with fixed JJ stent | All adult patients who undergo Double-J ureteral stent insertion for standard urological indications during the study period will be assessed for eligibility.
Patients will be followed until stent removal, and microbiological evaluation will be performed on both urine and stent specimens at the time of removal Receives: Diagnostic Test: Urine and stent cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal.
At removal, the stent will be handled under sterile conditions and sent for culture. If possible, the proximal and distal stent segments will be cultured separately to assess concordance between device segments.
Standard microbiological methods will be used to identify organisms and perform antimicrobial susceptibility testing.
The main endpoint of microbiological assessment will be bacterial colonization of the stent, defined as significant growth from the stent culture regardless of urine culture status.
patients will be classified as positive (if bacterial growth detected) or negative (if the culture was sterile)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UTIStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
- Investigators
- Mohamed Fawzy Salman, MD, Principal investigator, Lecturer of urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740811
- Sponsor's protocol ID
- Stent Bacterial Colonization
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07740811
- Acronym / sponsor ID
- Stent Bacterial Colonization
- Conditions
- UTI, Bacterial Colonization
- Keywords
- UTI, Bacterial colonization, JJ stent, infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 3 Aug 2026 (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.
To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.
Detailed description
Ureteral stents are indispensable in modern urology, but they are frequently complicated by bacterial colonization, biofilm formation, bacteriuria, and infectious morbidity.
Biofilm is clinically important because it promotes microbial persistence on the stent surface, reduces antimicrobial susceptibility, and may contribute to urinary tract infection (UTI) or even severe systemic infection in selected patients.
Prospective studies have shown that febrile ureteral stent-associated UTI occurs in a measurable proportion of patients and can progress to sepsis or septic shock in a subset.
More recent studies also confirm that colonization and resistance patterns vary by patient profile and stent dwell time.A major challenge in this field is that urine culture does not reliably exclude stent colonization.
Several studies have shown that a substantial proportion of patients with sterile urine still have colonized stents, meaning that urine testing alone may underestimate the burden of device-associated infection. In addition, the organisms recovered from stents are often more resistant than those isolated before stent insertion, which raises concern about delayed recognition and suboptimal empiric antibiotic choice in high-risk patients.
These findings support the need to study stent cultures and patient factors together rather than relying on urine culture alone.
The risk factors for bacterial colonization appear to be multifactorial, but the most consistently reported predictor is longer indwelling time. Other factors that have emerged across studies include diabetes mellitus, chronic kidney disease, pregnancy, prior urinary infection, prior catheterization, and albuminuria, although the strength of association is not uniform across all cohorts. Despite this, there is still limited prospective evidence integrating these predictors with clinical outcomes such as febrile UTI, symptom burden, and antimicrobial resistance.
Accordingly, we hypothesize that bacterial colonization of Double-J ureteral stents is associated with identifiable patient- and stent-related risk factors, especially prolonged indwelling time and metabolic or renal comorbidity, and that colonized stents are associated with clinically meaningful outcomes including bacteriuria, resistant organisms, and greater stent-related morbidity.
The significance of this study is that it may help refine patient counseling, improve timing of stent removal, and support targeted surveillance and antibiotic strategies in high-risk patients.
AIM OF THE STUDY To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with fixed JJ stent | – | Diagnostic Test: Urine and stent culturesAll adult patients who undergo Double-J ureteral stent insertion for standard urological indications during the study period will be assessed for eligibility. Patients will be followed until stent removal, and microbiological evaluation will be performed on both urine and stent specimens at the time of removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal. At stent removal, the stent will be handled under sterile conditions and sent for culture. If possible, the proximal and distal stent segments will be cultured separately to assess concordance between device segments. Standard microbiological methods will be used to identify organisms and perform antimicrobial susceptibility testing. The main endpoint of microbiological assessment will be bacterial colonization of the stent, defined as significant growth from the stent culture regardless of urine culture status. If resources permit, biofilm analysis or sonication-based processing may be added to improve detection
Key inclusion criteria (5 listed)
- Patients undergoing temporary Double-J ureteral stent insertion.
- Stent inserted for a standard urological indication, including ureteric stone disease, ureteral obstruction, postoperative drainage, or ureteral injury repair.
- Planned stent removal during the study follow-up period.
- Availability for clinical follow-up and specimen collection at insertion and removal.
- Provision of written informed consent.
Key exclusion criteria (7 listed)
- Active urosepsis at the time of stent insertion.
- Permanent or intended long-term stenting outside the study framework.
- Concomitant nephrostomy tube or urinary diversion that may confound microbiological results.
- Known severe immunosuppression or neutropenia if expected to substantially alter colonization risk.
- Patients with incomplete baseline clinical data.
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 |
|---|---|---|
| Urine and stent culturesAll adult patients who undergo Double-J ureteral stent insertion for standard urological indications during the study period will be assessed for eligibility. Patients will be followed until stent removal, and microbiological evaluation will be performed on both urine and stent specimens at the time of removal | Diagnostic test | Patients with fixed JJ stent |
Primary outcome
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
Time frame: 2 weeks
A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal. At removal, the stent will be handled under sterile conditions and sent for culture. If possible, the proximal and distal stent segments will be cultured separately to assess concordance between device segments. Standard microbiological methods will be used to identify organisms and perform antimicrobial susceptibility testing. The main endpoint of microbiological assessment will be bacterial colonization of the stent, defined as significant growth from the stent culture regardless of urine culture status. patients will be classified as positive (if bacterial growth detected) or negative (if the culture was sterile)
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 3 Aug 2026.
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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.
Mohamed Fawzy Salman, MD principal investigator
Lecturer of urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of UTI and Bacterial Colonization, run by Al-Azhar University at 1 site in Egypt.
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 5 inclusion and 7 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 3 Aug 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 Egypt. 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 Mohamed Fawzy Salman, MD (0201111788996, prof_mohamed_fawzy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal. (time frame: 2 weeks). 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 3 Aug 2026.