Antimicrobial Lubricant Did Not Reduce Infection Rate in Transrectal Biopsy Patients in a Large Randomized Trial Due to Low Complication Rates.

BACKGROUND: Transrectal prostate biopsy (pbx) is the most frequent outpatient procedure in the urological field. Septic complications are a major health issue.

OBJECTIVE: To evaluate complication rates with or without an antimicrobial lubricant.

DESIGN, SETTING, AND PARTICIPANTS: A total of 1000 patients received pbx between 2013 and 2015. Information about complications was collected by a 3-wk questionnaire. Return rate was 73.2% (n=732).

INTERVENTION: Randomization for pbx with the instillation of an antimicrobial lubricant (intervention group, n=385) or the standard lubricant (control group, n=347) was performed.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable analyses assessed the association between infectious complications at biopsy and use of an antimicrobial lubricant, International Prostate Symptom Score (IPSS), history of urogenitourinary infections, and several other confounders.

RESULTS AND LIMITATIONS: The use of an antimicrobial lubricant did not reduce infection rate. Overall complication rate was very low. Of all patients, 69.3% described the procedure as pain free. Fever ≥38.5°C was reported in overall 1.9% of patients. Urinary retention with catheterization occurred in 3.1%. Most common complications were hematospermia (47.4%), macrohematuria (23.8%), and rectal bleeding (7.4%). Readmission rate was 1% (n=7). In multivariable analyses, IPSS and previous infectious complications were associated with a higher risk of infectious complications. Our results stem from a large German single center and therefore are limited to this patient group.

CONCLUSIONS: No significant reduction was shown in infectious complications in the intervention group with the antimicrobial agent. Low incidence of those complications may be the underlying cause. Severe morbidity at pbx is uncommon. Specifically, the rate of infection was very low.

PATIENT SUMMARY: Severe complications at prostate biopsy are rare. Among participants, 69.3% had no pain. Fever was rare (1.9% of patients). Voiding issues with catheterization occurred in 3.1%. Most common complications were blood in the semen (47.4%), urine (23.8%), or stool (7.4%). Men with voiding issues or previous infectious complications had a higher risk of infectious complications.