Background and Objective
Prophylactic antibiotics are routinely given at the time of catheter removal post radical prostatectomy (RP). The low rate of infectious complications entails that large sample sizes are required for randomized controlled trials (RCTs), a challenge given the cost of standard RCTs. We evaluated infectious complications associated with 1 vs 3 days of prophylactic antibiotics at the time of catheter removal post RP using a novel, clinically-integrated trial with randomization at the surgeon level.
Methods
Surgeons were cluster randomized for periods of 3 months to prescribe 1-day versus 3-day regimen of prophylactic antibiotics at the time of catheter removal. The primary endpoint was an infectious complication as routinely captured by nursing phone call within 10 days of catheter removal and defined as: positive urine cultures (≥105 CFU) and at least 1 of the following symptoms: fever (>38C), urgency, frequency, dysuria or suprapubic tenderness.
Results
A total of 824 patients were consented and underwent RP, with respectively, 389 and 435 allocated to 1-and 3-day antibiotics, predominately ciprofloxacin. Accrual was achieved within 3 years: 95% and 88% of patients received the allocated 3-day or 1-day antibiotic regimen, respectively. There was 0 UTI (0%) in the 1-day regimen and 3 UTIs (0.7%) in the 3-day regimen, meeting our prespecified criterion for declaring the 1-day regimen to be non-inferior.
Conclusion
A clinically integrated trial using cluster randomization accrued rapidly with no important logistical problems and negligible burden on surgeons. If surgeons choose to prescribe empiric prophylactic antibiotics after catheter removal following RP, then the duration should not exceed 1 day.