A randomized trial regarding antimicrobial prophylaxis (AMP) in transurethral resection of bladder tumor (TURB).

PURPOSE: To determine whether omitting antimicrobial prophylaxis (AMP) in TURB is safe in patients undergoing TURB without an indwelling pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture. MATERIALS AND METHODS: A multi-centered randomized controlled trial (RCT) from 17-09-2017 to 31-12-2019 in 5 hospitals. Patients with a pre-operative indwelling catheter/DJ-stent or nephrostomy and a positive pre-operative urinary culture (> 104 uropathogens/mL) were excluded. Post-operative fever was defined as body temperature ≥ 38.3 °C. A non-inferiority design with a 6% noninferiority margin and null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (AMP-group) - E (no AMP-group) ≥ Δ (6% noninferiority margin). A multivariable, logistic regression was performed for AMP and post-TURB fever with covariates: tumor size and (clot-) retention. The R Project® for statistical computing was used for statistical analysis and a p value of 0.05 was considered as statistically significant. RESULTS: 459 Patients were included and 202/459 (44.1%) received AMP vs 257/459 (55.9%) without AMP. Fever occurred in 6/202 [2.9%; 95% CI (1.2-6.6%)] patients with AMP vs 8/257 [3.1%; 95% CI (1.5%-6.1%)] without AMP (p = 0.44). Multivariable, logistic regression showed no significant harm in omitting AMP when controlled for (clot-)retention and tumor size (p = 0.85) and an adjusted risk difference in developing post-TURB fever of 0.0016; 95% CI [- 0.029; 0.032]. CONCLUSION: Our data suggest the safety of omitting AMP in patients undergoing TURB without an indwelling, pre-operative catheter/nephrostomy/DJ and a negative pre-operative urinary culture.

Antimicrobial Prophylaxis in Transurethral Resection of the Prostate: Results of a Randomized Trial.

PURPOSE: We sought to determine whether omitting antimicrobial prophylaxis is safe in patients undergoing transurethral resection of the prostate without preoperative pyuria and a preoperative catheter. MATERIALS AND METHODS: We conducted a multicenter randomized controlled trial from September 17, 2017 until December 31, 2019 in 5 hospitals. Patients with pyuria (>100 white blood cells/ml) and a preoperative indwelling catheter were excluded. Postoperative fever was defined as a body temperature ≥38.3C. A noninferiority design was used with a 6% noninferiority margin and null hypothesis (H0) that the infection risk is at least 6% higher in the experimental (E) than in the control (C) group; H0: C (antimicrobial prophylaxis group) - E (no antimicrobial prophylaxis group) ≥ Δ (6% noninferiority margin). A multivariable, logistic regression was performed regarding posttransurethral resection of the prostate fever and antimicrobial prophylaxis with co-variates: (clot-)retention and operating time. The R Project® for statistical computing was used and a p value of 0.05 was considered as statistically significant. RESULTS: Of the patients 474 were included for multivariable analysis and 211/474 (44.5%) received antimicrobial prophylaxis vs 263/474 (55.5%) patients without antimicrobial prophylaxis. Antibiotics were fluoroquinolones in 140/211 (66.4%), cephazolin in 58/211 (27.5%) and amikacin in 13/211 (6.2%) patients. Fever occurred in 9/211 (4.4%) patients with antimicrobial prophylaxis vs 13/263 (4.9%) without antimicrobial prophylaxis (p=0.8, risk difference 0.006 [95% CI -0.003-0.06, relative risk 1.16]). We were able to exclude a meaningful increase in harm associated with omitting antimicrobial prophylaxis (p=0.4; adjusted risk difference 0.016 [95% CI -0.02-0.05]). CONCLUSIONS: Our data demonstrate the safety of omitting antimicrobial prophylaxis in patients undergoing transurethral resection of the prostate without preoperative pyuria and a preoperative indwelling catheter.

Adenocarcinoma of the prostate: innovations in management.

Adenocarcinoma of the prostate (CaP) in the Western world has become the most common noncutaneous human tumor. CaP is also the second most important cause of cancer deaths among the male population in the United States. Major progress was made in the past decade in better understanding this disease process, as well as in improved diagnostic accuracy. This improved diagnostic accuracy was due to wide application of prostate-specific antigen (PSA), use of transrectal ultrasound (TRUS), and greater awareness among clinicians of CaP. The use of PSA in clinical practice has resulted in a sharp increase in the number of patients diagnosed with capsule-confined tumors. The optimal treatment for capsule-confined CaP is in the process of being defined. Radical prostatectomy in the United States is currently the most commonly applied treatment for younger patients. Excellent treatment results with a 10-year actuarial survival > 80% are readily obtainable in properly selected patients. Nerve-sparing procedures helped reduce the high incidence of impotence that occurs in patients after radical retropubic prostatectomy. Radiotherapy remains the other curative treatment method in the management of CaP patients, with long-term survival rates similar to those reported in surgical series. Due to the problem of frequent preoperative tumor understaging, a routine use of postoperative irradiation to the prostatic fossa produces an excellent (> 95%) incidence of local tumor control. Management of patients with metastatic disease has undergone a considerable evolution with the development of modern hormonal management and treatment with strontium-89 to control intractable bone pain. Newer treatment methods such as hyperthermia are currently being investigated. Major efforts are directed toward the reduction of short- and long-term treatment toxicity associated with surgery, radiotherapy, and hormonal management, thus improving patient quality of life.