Bacterial ColonizationNCT07760792
Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization
An observational study of Bacterial Colonization and Double-J Ureteral Stents, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This prospective cohort study will evaluate the risk factors associated with bacterial colonization of Double-J ureteral stents and examine its clinical implications. Adult patients undergoing temporary ureteral stent insertion for routine urological indications will be followed until stent removal, when urine and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Colonization, Double-J Ureteral Stents
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2026to 30 Jul 2027
- How long will I take part?
- 48 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: Adults with temporary Double-J ureteral stents placed for routine urological indications and available for follow-up until stent removal.
Who may be able to join
- Age 18 years or older.
- Temporary Double-J stent insertion.
- Standard urological indication.
- Planned stent removal during follow-up.
- Ability to attend follow-up and provide specimens.
- Written informed consent.
Who cannot join
- Active urosepsis at insertion.
- Permanent or intended long-term stenting.
- Concomitant nephrostomy tube or urinary diversion.
- Severe immunosuppression or neutropenia.
- Incomplete baseline data.
- Loss to follow-up or failure to retrieve the stent.
- 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
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo, Cairo Governorate, 11633
Abul-fotouh Ahmed, MD, +201001066756, abulfotouhahmed@yahoo.com
Mahmoud M Abdelmalik
About this study
Official title: Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
This prospective cohort study will evaluate the risk factors associated with bacterial colonization of Double-J ureteral stents and examine its clinical implications. Adult patients undergoing temporary ureteral stent insertion for routine urological indications will be followed until stent removal, when urine and stent cultures will be obtained. The study will assess the association between colonization and factors such as indwelling time, diabetes mellitus, chronic kidney disease, prior urinary tract infection, prior antibiotic exposure, and stent-related symptoms.
Read the detailed description
This prospective observational cohort study will enroll adult patients undergoing temporary Double-J ureteral stent insertion at Al-Azhar University hospitals in Cairo, Egypt. Participants will be followed from stent insertion until removal. Baseline demographic, clinical, and laboratory data will be collected, together with stent-related variables such as stent side, size, material, and indwelling time. Midstream urine culture will be obtained when feasible before insertion and again at removal, and the stent will be cultured under sterile conditions at removal.
The primary outcome is bacterial colonization of the Double-J stent, defined as positive growth on stent culture at removal. Secondary outcomes include positive urine culture, febrile urinary tract infection, concordance between urine and stent cultures, antimicrobial resistance patterns, stent-related symptom burden, and need for hospitalization or additional treatment. Risk factors for colonization will be analyzed using multivariable logistic regression.
- Conditions
- Bacterial Colonization, Double-J Ureteral Stents
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
Positive growth on stent culture at removal.
Measured: At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Secondary outcomes (6)
Positive urine culture
Positive midstream urine culture during stent indwelling or at removal.
Measured: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Number of Participants With Febrile Urinary Tract Infection
Development of urinary tract infection while the stent is in place; Confirmed by Clinical Assessment and Urine Culture
Measured: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Agreement between urine culture and stent culture
Agreement between urine culture and stent culture, assessed by Cohen's kappa coefficient
Measured: At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Antimicrobial resistance profile
Resistance pattern of organisms isolated from urine and stent cultures.
Measured: At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Stent-related symptom burden
Symptoms such as flank pain, dysuria, hematuria, frequency, and urgency, assessed by questionnaire if available.
Measured: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Hospitalization or additional intervention
Need for emergency visit, admission, or additional treatment related to stent-associated complications.
Measured: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start10 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ColonizationStudies 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
- 300 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
- Investigators
- Abul-fotouh Ahmed, MD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760792
- Sponsor's protocol ID
- UroAzhar_9_026
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 1 Sep 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 1 Sep 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
- NCT07760792
- Acronym / sponsor ID
- UroAzhar_9_026
- Conditions
- Bacterial Colonization, Double-J Ureteral Stents
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 12 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.
This prospective cohort study will evaluate the risk factors associated with bacterial colonization of Double-J ureteral stents and examine its clinical implications. Adult patients undergoing temporary ureteral stent insertion for routine urological indications will be followed until stent removal, when urine and stent cultures will be obtained. The study will assess the association between colonization and factors such as indwelling time, diabetes mellitus, chronic kidney disease, prior urinary tract infection, prior antibiotic exposure, and stent-related symptoms.
Detailed description
This prospective observational cohort study will enroll adult patients undergoing temporary Double-J ureteral stent insertion at Al-Azhar University hospitals in Cairo, Egypt. Participants will be followed from stent insertion until removal. Baseline demographic, clinical, and laboratory data will be collected, together with stent-related variables such as stent side, size, material, and indwelling time. Midstream urine culture will be obtained when feasible before insertion and again at removal, and the stent will be cultured under sterile conditions at removal.
The primary outcome is bacterial colonization of the Double-J stent, defined as positive growth on stent culture at removal. Secondary outcomes include positive urine culture, febrile urinary tract infection, concordance between urine and stent cultures, antimicrobial resistance patterns, stent-related symptom burden, and need for hospitalization or additional treatment. Risk factors for colonization will be analyzed using multivariable logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with temporary Double-J ureteral stents placed for routine urological indications and available for follow-up until stent removal.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Temporary Double-J stent insertion.
- Standard urological indication.
- Planned stent removal during follow-up.
- Ability to attend follow-up and provide specimens.
Key exclusion criteria (7 listed)
- Active urosepsis at insertion.
- Permanent or intended long-term stenting.
- Concomitant nephrostomy tube or urinary diversion.
- Severe immunosuppression or neutropenia.
- Incomplete baseline data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial colonization of the Double-J ureteral stent
Time frame: At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Positive growth on stent culture at removal.
6 secondary outcomes
Positive urine culture
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Number of Participants With Febrile Urinary Tract Infection
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Agreement between urine culture and stent culture
Time frame: At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Antimicrobial resistance profile
Time frame: At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Stent-related symptom burden
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Hospitalization or additional intervention
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
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 1 Sep 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.
Abul-fotouh Ahmed, MD principal investigator
Al-Azhar University
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 Bacterial Colonization and Double-J Ureteral Stents, 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 6 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 1 Sep 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 Abul-fotouh Ahmed, MD (00201001066756, abulfotouhahmed@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 (time frame: At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.). 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 1 Sep 2026.