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

A Randomized Controlled Trial Evaluating the Effect of Routine Probe Compression After Transrectal Prostate Biopsy on Bleeding and Infectious Complications

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Biopsy; Post Biopsy Bleeding; Transrectal Ultrasound-guided Prostate Biopsy
• Intervention / Treatment: Behavioral: Probe compression

Detailed Description

Hematuria (approximately 50%) and rectal bleeding (approximately 30%) are common complications following transrectal ultrasound-guided prostate biopsy [1-3]. Although most cases are self-limited, a subset of patients require additional intervention [4]. In cases of significant bleeding immediately after biopsy, ultrasound-guided probe compression has been used for hemostasis, with reported compression times ranging from 1 to 8 minutes (mean 2.9 minutes), suggesting that even short-duration compression may be effective [4].

Digital rectal compression for 5 minutes after biopsy has been shown to reduce intraprostatic hemorrhage (hematoma), thereby improving the accuracy of subsequent magnetic resonance imaging interpretation [5]. However, no randomized controlled trials have evaluated clinically significant bleeding outcomes, such as hematuria or rectal bleeding, as primary endpoints [5].

While a stepwise approach to managing moderate-to-severe rectal bleeding (initial direct compression followed by endoscopic hemostasis or embolization if needed) is generally accepted, there is no consensus regarding the optimal duration of initial compression [6].

Infectious complications following transrectal prostate biopsy occur in approximately 0.1-7.0% of patients, with sepsis reported in 0.3-3.1% [7]. Post-biopsy hematuria has been suggested as a potential clinical indicator of subsequent urinary tract infection [8]. Therefore, reducing bleeding complications may also contribute to the prevention of infectious complications.

There is a clear need for randomized evidence evaluating the effect of routine probe compression and compression duration on both bleeding and infectious outcomes. This study aims to address this gap in the current evidence.

Study Procedures

Participants will be randomly assigned in a 1:1:1 ratio immediately after transrectal ultrasound-guided prostate biopsy using a computer-generated randomization schedule to one of three groups based on probe compression duration: 0 minutes (no compression), 1 minute, or 3 minutes.

Probe compression will be performed by a designated study investigator immediately after biopsy. Blinding will be maintained as much as feasible: the operator, participants, and outcome assessors will be blinded to group allocation whenever possible.

All participants will receive standard prophylactic measures according to institutional practice, including a single dose of intravenous ceftriaxone (2 g) followed by oral levofloxacin (500 mg) for 3 days, as well as rectal disinfection prior to biopsy.

Follow-up will include a structured telephone interview within 7 days after biopsy to assess post-procedural symptoms (approximately 3 minutes in duration). In addition, participants will undergo an outpatient clinic visit between 7 and 14 days after biopsy, during which routine laboratory tests, including complete blood count (CBC), C-reactive protein (CRP), and urinalysis, will be performed.

The study intervention may increase the total procedure time by up to 3 minutes, depending on the assigned compression duration (0, 1, or 3 minutes).

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 05368
      • Recruiting
      • VHS Medical Center
      • Contact: Jaehyun Ryu, MD; Phone Number: +82-10-5234-1222; Email: ryujaehyun1@gmail.com
      • Principal Investigator: Jaehyun Ryu, MD
      • Sub-Investigator: Inseok Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Probe compression (0 minutes); No probe compression is applied after completion of transrectal ultrasound-guided prostate biopsy.
Active Comparator: Probe compression (1 minute); 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 using the transrectal ultrasound probe applied immediately after biopsy, with duration of 0, 1, or 3 minutes according to randomization.
Active Comparator: Probe compression (3 minutes); 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; Probe compression using the transrectal ultrasound probe applied immediately after biopsy, with duration of 0, 1, or 3 minutes according to randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infectious complications	Occurrence of fever, urinary tract infection, or sepsis based on patient-reported symptoms and laboratory findings.	Within 14 days after biopsy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BOHUN-2026-01-044-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No