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NCT Number: NCT07463963

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Urine bacterial Culture (UC)

Diagnostic Test

Performing a systematic UC before the TURB surgery

No intervention before TURB surgery

Other

No Urine Culture before TURB Surgery

Primary outcomes

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

    Time frame: During the 30 days following TURB surgery.

    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

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 (in days), defined by 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

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

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

  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

    Time frame: Within 30 days following the TURB surgery

    Proportion of patients with systemic UTI among patients with hospital readmission, defined as UTI complicated by sepsis (corresponding to a qSOFA > 1)

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

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

  10. Overall survival time

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maxime VALLEE, MD

CONTACT

[email protected]

+33 5 16 60 42 22

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: RUPTURE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 11, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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