Clinical trial · Interventional
Relevance of the Urine Bacterial Culture Performed Before TransUrethral Resection of the Bladder for Post-operative Febrile Urinary Tract Infections Prevention: a Non-inferiority Randomized Controlled Trial
NCT07463963CI-TRIAL-00126007RUPTURErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of the study is to demonstrate that not performing a systematic UC before the TURB procedure is non-inferior to performing a systematic UC in terms of the incidence of febrile UTIs during the first 30 postoperative days
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Transurethral Resection of the Bladder | — | UNRESOLVED | — |
| Urinary Tract Infection Bacterial | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention before TURB surgery | Other | — | UNRESOLVED |
| Urine bacterial Culture (UC) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB)
- interventionNames
- Other: No intervention before TURB surgery
- type
- ACTIVE_COMPARATOR
- label
- Urine Bacterial Culture performed 4 to 10 days before TURB
- interventionNames
- Diagnostic Test: Urine bacterial Culture (UC)
Primary outcomes (1)
- measure
- Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI)
- timeFrame
- During the 30 days following TURB surgery.
- description
- The diagnosis of a febrile UTI will be based on clinical, biological and microbiological criteria, as defined by Bilsen et al. based on an international expert consensus (PMID: 38458204)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged 18 or over * Scheduled for TURB surgery for a suspected or confirmed diagnosis of bladder tumor * Affiliated person or beneficiary of a social security scheme * Written informed consent obtained from the participant Exclusion Criteria: * Patient with active UTI * Planned combined surgery * Patient previously included in this research protocol * People benefiting from enhanced protection, namely minors, people deprived of their liberty by judicial or administrative decision, people staying in a health or social institution, adults under legal protection * Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation : oral, intravaginal, transdermal; Progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable; Intrauterine device; Intrauterine hormone-releasing system; Bilateral tubal occlusion) or permanent sterilization methods ( hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
References
Publications (0)
Data not yet available
No reference posted for this study.