Can we predict which stents will harbor bacteria?
NCT ID NCT07740811
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This study follows 400 adults who receive a Double-J ureteral stent—a tube that helps drain urine from the kidney to the bladder. The goal is to identify risk factors for bacteria sticking to the stent and to see how this colonization relates to urinary tract infections, antibiotic resistance, and stent-related symptoms. Urine and stent samples are collected at removal and tested for bacterial growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Urine and stent cultures (diagnostic test)
- What this could lead to
- If successful, this could identify which patients are at higher risk for stent-related infections and guide strategies to prevent them, potentially reducing antibiotic resistance.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. Results may not apply to all patient groups, and the findings might not lead to immediate changes in clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mohamed Fawzy Salman
RECRUITINGCairo, Egypt
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