Routine Probe Compression After Transrectal Prostate Biopsy(RPCAB) to Reduce Bleeding and Infectious Complications

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorVeterans Health Service Medical Center, Seoul, Korea

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Probe compression

    Behavioral

    Probe compression using the transrectal ultrasound probe applied immediately after biopsy, with duration of 0, 1, or 3 minutes according to randomization.

Treatment groups

324 Participants
are divided into 3 treatment groups
Group A: Probe compression (0 minutes)No intervention 0 interventions
Group B: Probe compression (1 minute)Active comparator 1 intervention
Group C: Probe compression (3 minutes)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 7 days after biopsy

Secondary outcomes

1

Incidence of infectious complications

Occurrence of fever, urinary tract infection, or sepsis based on patient-reported symptoms and laboratory findings.

Time frame
Within 14 days after biopsy

Other outcomes

Sponsors and contacts

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