About this trial
Hematuria (up to 50%) and rectal bleeding (up to 30%) are common complications following transrectal ultrasound-guided prostate biopsy. Although most cases are mild, some require additional intervention. Short-duration compression has been shown to achieve hemostasis in cases of post-biopsy bleeding, suggesting that routine probe compression may reduce bleeding complications. Post-biopsy bleeding may also be associated with an increased risk of subsequent infection.
This randomized controlled trial aims to evaluate the effect of routine probe compression and compression duration after transrectal prostate biopsy on bleeding and infectious complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged ≥18 years
Scheduled to undergo transrectal ultrasound-guided prostate biopsy
Biopsy-naïve patients (first-time prostate biopsy)
Able to provide written informed consent
Disqualifiers
Uncorrectable coagulopathy or bleeding disorder
Active urinary tract infection at the time of biopsy
Acute anorectal conditions (e.g., hemorrhoidal bleeding, anal fissure, proctitis)
Inability to discontinue or appropriately manage anticoagulant or antiplatelet therapy
Trial design
Parallel
Treatments tested in this trial
Probe compression
BehavioralProbe compression using the transrectal ultrasound probe applied immediately after biopsy, with duration of 0, 1, or 3 minutes according to randomization.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of clinically significant bleeding after transrectal prostate biopsy
Proportion of patients reporting hematuria or rectal bleeding within 7 days after biopsy, assessed by structured telephone interview. Clinically significant bleeding is defined as bleeding associated with patient-reported symptoms, prolonged duration, or requiring medical attention.
Secondary outcomes
Incidence of infectious complications
Occurrence of fever, urinary tract infection, or sepsis based on patient-reported symptoms and laboratory findings.
Sponsors and contacts
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