Routine Probe Compression After Transrectal Prostate Biopsy(RPCAB) to Reduce Bleeding and Infectious Complications : A Randomized Controlled Trial

NCT07550985 | Recruiting

• 1 other identifier: BOHUN-2026-01-044-002
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Biopsy; Post Biopsy Bleeding; Transrectal Ultrasound-guided Prostate Biopsy

Outcome Measures

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.

  Within 7 days after biopsy

Secondary Outcomes (1)

• Incidence of infectious complications

  Within 14 days after biopsy

Study Arms (3)

Probe compression (0 minutes)

NO INTERVENTION

No probe compression is applied after completion of transrectal ultrasound-guided prostate biopsy.

Probe compression (1 minute)

ACTIVE COMPARATOR

The transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 1 minute immediately after biopsy.

Behavioral: Probe compression

Probe compression (3 minutes)

ACTIVE COMPARATOR

The transrectal ultrasound probe is used to apply continuous manual pressure to the prostate via the rectal wall for 3 minutes immediately after biopsy.

Behavioral: Probe compression

Interventions

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.

Probe compression (1 minute); Probe compression (3 minutes)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 History of severe drug allergy or hypersensitivity to medications used in the study Individuals unable to provide informed consent (e.g., cognitive impairment, medically incapacitated) or other vulnerable populations Participation in another interventional study related to prostate disease that may interfere with the outcomes of this study Severe comorbid conditions limiting study participation Inability to comply with follow-up procedures

Sponsors & Collaborators

• Veterans Health Service Medical Center, Seoul, Korea: lead

Study Sites (1)

VHS medical center

Seoul, Seoul, 05368, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

KR (1)