Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical
Badar M Mian1, Paul J Feustel2, Asef Aziz1
1Department of Urology, Albany Medical Center, Albany, New York.
Purpose:
Transrectal prostate biopsy has come under scrutiny due to potential for postbiopsy infections and transperineal prostate biopsy is being offered as the safer alternative. However, there is a lack of randomized comparative studies. Our goal was to directly evaluate infectious and noninfectious complications following the 2 biopsy procedures.
Materials And Methods:
We conducted a prospective, pragmatic, randomized clinical study in men undergoing prostate biopsy. The participants underwent either transrectal or transperineal prostate biopsy in the office under local anesthesia. The primary outcome was a 30-day composite infectious complication rate, comprising of 1 or more components including fever, genitourinary infection, antibiotic prescriptions, office or emergency visits, hospitalization, or sepsis. Secondary outcomes included 30-day composite noninfectious complications (urinary or hemorrhagic).
Results:
Of the 763 randomized participants, 718 underwent either transrectal (351) or transperineal (367) prostate biopsy. A composite infectious complication event occurred in 9 participants (2.6%) in the transrectal and 10 participants (2.7%) in the transperineal group (odds ratio, 1.06; 95% CI, 0.43 to 2.65; P = .99). None of the participants developed sepsis in either group. There were no between-group differences in any of the individual component infectious events. A composite noninfectious complication occurred in 6 (1.7%) and 8 (2.2%) participants in the transrectal and transperineal groups, respectively (odds ratio, 1.28; 95% CI, 0.44 to 3.73; P = .79). No participants required hospitalization or other interventions.
Conclusions:
Among men undergoing transperineal or transrectal prostate biopsy, we could not demonstrate any difference in the infectious or noninfectious complications. Both biopsy approaches remain clinically viable and safe.
Insights
Transrectal and transperineal prostate biopsies showed similar infectious and noninfectious complication rates in a randomized study. Both methods are safe and clinically viable options for prostate cancer diagnosis.
Area of Science:
- Urology
- Surgical Oncology
- Infectious Diseases
Background:
- Transrectal prostate biopsy is associated with infection risks.
- Transperineal prostate biopsy is proposed as a safer alternative.
- Limited randomized comparative data exists for complication rates.
Purpose of the Study:
- To directly compare infectious and noninfectious complications of transrectal versus transperineal prostate biopsy.
- To evaluate the safety and clinical viability of both prostate biopsy techniques.
Main Methods:
- Prospective, pragmatic, randomized clinical study.
- Participants underwent transrectal or transperineal prostate biopsy under local anesthesia.
- Primary outcome: 30-day composite infectious complication rate; Secondary outcome: 30-day composite noninfectious complications.
Main Results:
- No significant difference in composite infectious complication rates between transrectal (2.6%) and transperineal (2.7%) groups (P=.99).
- No significant difference in composite noninfectious complication rates between groups.
- No sepsis or hospitalizations occurred in either group.
Conclusions:
- Transrectal and transperineal prostate biopsies demonstrate comparable safety profiles regarding infectious and noninfectious complications.
- Both biopsy approaches are clinically viable and safe for men undergoing prostate biopsy.
