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PROSTABACT : Relevance of the treatment with antibiotics before endoscopic surgery of lower urinary symptoms related to prostate hypertrophy with polymicrobial bacterial culture performed before the surgery: a non-inferiority randomized trial

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510191-31-00
Acronym
DR230286
Enrollment
380
Registered
2025-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia

Brief summary

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).

Detailed description

Number of patients whose procedure is cancelled in each group, Infection characteristics (type of bacteria, clinical data, hospitalization…), 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, 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%)., 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., Description of baseline urine microbiota in both groups (patients who developed an infection and patients who did not)

Interventions

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
Number of patients whose procedure is cancelled in each group, Infection characteristics (type of bacteria, clinical data, hospitalization…), 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, 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%)., 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., Description of baseline urine microbiota in both groups (patients who developed an infection and patients who did not)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026