Bromhexine hydrochloride; Sulfamethoxazole; Trimethoprim for Benign prostatic hyperplasia

Inclusion criteria

• {"criterion_text":"- Adult men ≥ 18 years of age\n- Person affiliated to a French social security system or equivalent\n- Written informed consent obtained from the participant\n- Scheduled to have a surgery of lower urinary Tract Symptoms (LUTS) due to BPH, (Urolift, rezum, aquabeam, monopolar or bipolar Trans-uretral resection of the prostate, enucleation of the prostate (Holep, Greenlep, bipolep), simple prostatectomy)\n- With polymicrobial pre-operative urine culture (three or more pathogens identified).\n- Able to comply with the requirements of the study\n- Patients able to understand this clinical research"}

Exclusion criteria

• {"criterion_text":"- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: persons deprived of their liberty by judicial or administrative decision and persons subject to a legal protection measure: guardianship or trusteeship)\n- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)\n- Patients already treated by antibiotic for non-urological situations\n- Concomitant participation in other pharmacological study\n- Patients in medical emergency\n- Mental state making the patient unable to understand this research\n- Patient being the investigator as well as any member of the team or close relative of the investigator directly involved in the trial, in particular assistant doctors, pharmacists, nurses, trial coordinator\n- Contraindications to antibiotic drugs administered in this study\n- Infection within 6 months before surgery\n- Hospitalisation within 6 months before surgery"}

Primary endpoints

• {"endpoint_text":"- Incidence over a one-month post-operative period of a symptomatic urinary infection defined by the presence of symptoms validated by a blinded independent adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria).","definition_or_measurement_approach":"Symptomatic urinary infection defined by presence of symptoms validated by a blinded independent adjudication committee (examples: urine burning, fever, urinary urgency) associated with significant bacteriuria; incidence measured over one month post-operatively."}

Secondary endpoints

• {"endpoint_text":"- Number of patients whose procedure is cancelled in each group","definition_or_measurement_approach":"Count of patients with cancelled procedures in each randomized group."}
• {"endpoint_text":"- Infection characteristics (type of bacteria, clinical data, hospitalization…)","definition_or_measurement_approach":"Descriptive comparison of infection characteristics including bacterial type, clinical data, and hospitalization events."}
• {"endpoint_text":"- Cost of antibiotics used to treat with antibiotics a polymicrobial UBC performed before endoscopic treatments of BPH and in the one-month post-operative surgical treatment","definition_or_measurement_approach":"Cost evaluation of antibiotics used before surgery and during the one-month post-operative period."}
• {"endpoint_text":"- Probability that the experimental strategy is clinically and economically non-inferior to the control strategy for different values of economic non-inferiority margin and for a constant clinical non-inferiority margin (10%).","definition_or_measurement_approach":"Joint clinical and economic non-inferiority analysis using a clinical non-inferiority margin of 10% and varying economic margins."}
• {"endpoint_text":"- Economic impact per year and per cumulative years of a change in prescribing practices for polymicrobial UBC before endoscopic surgery of BPH, from the French Health Insurance perspective, over a 5-year period.","definition_or_measurement_approach":"Budget impact modelling from French Health Insurance perspective over 5 years."}
• {"endpoint_text":"- Description of baseline urine microbiota in both groups (patients who developed an infection and patients who did not)","definition_or_measurement_approach":"Descriptive analysis of baseline urine microbiota comparing patients who developed post-operative infection versus those who did not."}

Methods

• Patients scheduled for lower urinary tract surgery (for BPH) who have a pre-operative urine bacterial culture (performed 7 to 10 days before surgery) showing a polymicrobial culture will be contacted to confirm willingness to be included; recruitment is site-based at participating hospitals in France.

France

Earliest CTIS Part Ii Submission Date

07-01-2025

Latest Decision Or Authorization Date

17-02-2025

Processing Time Days

41

Number Of Sites

14

Number Of Participants

380

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France