Abstract
BackgroundTransurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is recommended to reduce postoperative urinary tract infections. So far, no international recommendations for AP have been established for GL. In a survey-based study in Switzerland, Germany and Austria, urologists reported routinely extending AP primarily for 3 days after both interventions. We therefore aim to determine whether single-dose AP with cotrimoxazole is non-inferior to 3-day AP with cotrimoxazole in patients undergoing TURP or GL of the prostate.Methods/designWe will conduct an investigator-initiated, multicentre, randomised controlled trial. We plan to assess the non-inferiority of single-dose AP compared to 3-day AP. The primary outcome is the occurrence of clinically diagnosed symptomatic urinary tract infections which are treated with antimicrobial agents within 30 days after randomisation. The vast majority of collected outcomes will be assessed from routinely collected data. The sample size was estimated to be able to show the non-inferiority of single-dose AP compared to 3-day AP with at least 80% power (1 – β = 0.8) at a significance level of α = 5%, applying a 1:1 randomisation scheme. The non-inferiority margin was determined in order to preserve 70% of the effect of usual care on the primary outcome. For an assumed event rate of 9% in both treatment arms, this resulted in a non-inferiority margin of 4.4% (i.e. 13.4% to 9%). To prove non-inferiority, a total of 1574 patients should be recruited, in order to have 1416 evaluable patients. The study is supported by the Swiss National Science Foundation.DiscussionFor AP in TURP and GL, there is a large gap between usual clinical practice and evidence-based guidelines. If single-dose AP proves non-inferior to prolonged AP, our study findings may help to reduce the duration of AP in daily routine—potentially reducing the risk of emerging resistance and complications related to AP.Trial registrationClinicaltrials.gov, NCT03633643. Registered 16 August 2018.
Highlights
Transurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures
If single-dose antimicrobial prophylaxis (AP) proves non-inferior to prolonged AP, our study findings may help to reduce the duration of AP in daily routine—potentially reducing the risk of emerging resistance and complications related to AP
A systematic review and meta-analysis published in 2013 including a total of 42 clinical trials indicated that, in urological surgery, AP versus placebo substantially reduced the risk for bacteriuria (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.29 to 0.46), urinary tract infections (UTIs) (RR 0.38, 95% CI 0.28 to 0.51), bacteraemia (RR 0.43, 95% CI 0.23 to 0.82) and fever above 38.5 °C (RR 0.41, 95% CI 0.23 to 0.73)
Summary
Antimicrobial resistance is prevalent among the main pathogens of the urogenital tract [18, 19]. Non-randomised observational methods would carry a high risk of bias and would not allow one to draw causal inferences about the comparative merits of both treatment strategies In this multicentre RCT, we will investigate, in patients undergoing either TURP or GL for obstructive voiding disorders, the non-inferiority of single-dose AP with cotrimoxazole against 3-day AP with cotrimoxazole in terms of the proportion of UTIs within 30 days which require antimicrobial treatment. We would consider it acceptable when approximately four more of 100 patients (13 patients instead of 9) would have a UTI when bearing in mind that these four UTIs can be treated relatively straightforward with antibiotics and that simultaneously the use of AP can be strongly decreased in all 100 treated patients This may reduce individual adverse events and development of resistant pathogens. Additional file 2: World Health Organization Trial Registration Data Set. (DOCX 23 kb)
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