ClinicalTrials.gg
RecruitingNCT07463963RUPTUREUpdated Sep 4, 2026

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

An interventional study of Urine bacterial Culture (UC) and No intervention before TURB surgery in Bladder Cancer, Transurethral Resection of the Bladder and Urinary Tract Infection Bacterial, sponsored by Poitiers University Hospital. Recruiting at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 160 studies in Urinary Bladder Neoplasms with a site in France — 40 open to participants now, 62 under way, 15 of them phase 3. Urinary Bladder Neoplasms · France.

Planned enrollment
Largest of 129
2,600 · median 169
Started
2026
with 7 others
No phase
17 of 160
7 open now
Primary completion
2030-07
later than 55 of 61 live
Registered
156th of 160
by date

Among the 160 studies in Urinary Bladder Neoplasms with a site in France, this one has the largest planned enrollment of the 129 interventional ones that give a count, is one of 8 that started in 2026, is one of 17 with no phase, reaches primary completion later than 55 of the 61 other live ones, and was the 156th registered.

Urinary Bladder Neoplasms

1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.

Browse Urinary Bladder Neoplasms studies →

Open to participants now

40 of the 160 studies in Urinary Bladder Neoplasms with a site in France are open now. Recruiting first, the newest first:

34 more — sign in →

All 40 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the detailed description

Transurethral resection of the bladder (TURB) is a routinely performed surgery in urology (65,000/y in France). Its primary indication is the management of bladder cancer for diagnostic, prognostic, and therapeutic purposes. Currently, both French and European guidelines recommend screening for asymptomatic bacteriuria (ABU) using a urine culture (UC) before TURB. If the UC is positive, antibiotic treatment must be initiated 48 hours before surgery and continued for a maximum of 7 days after the procedure. Theoretically, the purpose of preoperative ABU screening before TURB is to reduce the rate of post-operative urinary tract infections (UTIs). However, there is currently a lack of high-level studies justifying this approach, despite its being a recommended practice. The literature estimates the rate of post-TURB UTIs to be between 2% and 3.7%. In a recent French multicentre retrospective study, the rate of postoperative febrile UTI was 2.3%. This study did not find a significant association between positive pre-operative UC and a post-operative febrile UTI. Moreover, these post-TURB infections are generally of moderate severity (Grade 2 of Clavien-Dindo classification) and do not progress to sepsis. The rate of severe infections is estimated between 0.3% and 0.74%, and no study has yet demonstrated the link between the presence of a positive preoperative UC and an increased risk of postoperative infection. The causality between preoperative UC and postoperative UTIs remains unestablished. According to the TOCUS study, approximately one-third of patients exhibit ABU before undergoing urological surgery, translating to approximately 20,000 patients annually in France. Despite the relatively low rate of post-TURB UTIs and their mild severity, guidelines mandate antibiotic treatment for these patients. Antibiotic resistance is now a daily concern for clinicians and countries alike. A prominent 2014 WHO report emphasized the consequences of antibiotic resistance, including its impact on morbidity, mortality, and societal costs. The risk of entering a post-antibiotic era by 2050 could become a reality if strong measures are not taken immediately. Therefore, we propose a non- inferiority randomized controlled trial to investigate the impact of not performing pre-operative UC before TURB on the incidence of post-TURB febrile UTIs.

03

Conditions studied

  • Bladder Cancer
  • Transurethral Resection of the Bladder
  • Urinary Tract Infection Bacterial

Keywords

  • Urine Culture
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 obtained from the participant

Exclusion criteria

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 (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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,600 participants (estimated)

Study arms

  • Experimental
    No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB)

    Other: No intervention before TURB surgery

  • Active comparator
    Urine Bacterial Culture performed 4 to 10 days before TURB

    Diagnostic Test: Urine bacterial Culture (UC)

Interventions

  • Diagnostic testUrine bacterial Culture (UC)

    Performing a systematic UC before the TURB surgery

  • OtherNo intervention before TURB surgery

    No Urine Culture before TURB Surgery

06

What researchers measure

Primary outcomes

  1. Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI)

    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)

    Time frame: During the 30 days following TURB surgery.

Secondary outcomes

  1. Proportion of patients with postponed TURB surgery

    Time frame: Between the pre-operative consultation and date of TURB surgery, up to 60 days

  2. Time to surgery

    time to surgery (in days) is defined as the number of days between the pre-operative consultation and the date of TURB surgery

    Time frame: Between the pre-operative consultation and the date of TURB surgery, up to 60 days

  3. The hospital length of stay

    The hospital length of stay , defined by the number of days between surgery and discharge from the hospital

    Time frame: Between TURB surgery and day 30 after TURB surgery

  4. Proportion of patients with hospital readmission or postoperative complications

    Time frame: Within 30 days following the TURB surgery

  5. Proportion of patients with hospital readmission linked to the urinary surgical procedure

    Time frame: Within 30 days following the TURB surgery

  6. Proportion of patients with systemic UTI among patients with hospital readmission

    Systemic UTI is defined as UTI complicated by sepsis (corresponding to a qSOFA \> 1)

    Time frame: Within 30 days following the TURB surgery

  7. Proportion of patients with pre-operative antibiotic prescription for preoperative colonization before the TURB surgery

    Time frame: Between Visit 0 (pre-operative consultation) and Visit 1(TURB surgery)

  8. Proportion of patients with post-operative antibiotic prescription

    Time frame: Within 30 days following the TURB surgery

  9. Time to post-TURB infection diagnosis

    Time to post-TURB infection diagnosis (in days), defined by the time between TURB surgery and the infection diagnosis date (truncated at day 30)

    Time frame: Between the TURB surgery and the infection diagnosis date (truncated at day 30)

  10. Overall survival time

    Overall survival time (in days), defined by the time between TURB surgery and the date of death (censored at day 30).

    Time frame: Between TURB surgery and the date of death (censored at day 30)

07

Study locations

3 of 15 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jul 2030, 49 months after the start.

Of 235 non-industry interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's planned 49 months is above that.

Counting every sponsor, half of 244 studies reached it within 39 months; a quarter within 20 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2026
First posted
Mar 11, 2026
StartActual
Jun 29, 2026
Primary completionEst.
Jul 29, 2030
CompletionEst.
Aug 15, 2030
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07463963
Responsible party
Sponsor
First posted
Mar 11, 2026
Start date
Jun 29, 2026
Primary completion
Jul 29, 2030 (estimated)
Completion
Aug 15, 2030 (estimated)
Last update
Sep 4, 2026

Study contacts

Maxime VALLEE, MD
Contact
maxime.vallee@chu-poitiers.fr
+33 5 16 60 42 22

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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