Probe compression after transrectal prostate biopsy to reduce bleeding and infection
A Randomized Controlled Trial Evaluating the Effect of Routine Probe Compression After Transrectal Prostate Biopsy on Bleeding and Infectious Complications
This trial will test whether briefly pressing the ultrasound probe after a first-time transrectal prostate biopsy lowers bleeding and infection risk in adult men.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Veterans Health Service Medical Center, Seoul, Korea Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT07550985 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares routine probe compression and different compression durations applied immediately after transrectal ultrasound-guided prostate biopsy to measure rates of hematuria, rectal bleeding, and infectious complications. Eligible men are age 18 or older undergoing their first transrectal biopsy who can provide informed consent and appropriately manage anticoagulation; key exclusions include uncorrectable coagulopathy, active urinary tract infection, or acute anorectal conditions. The intervention uses short-duration ultrasound-guided rectal probe compression (with predefined time intervals) versus usual care, and participants are followed for clinically significant bleeding events and post-biopsy infections. The trial is conducted at Veterans Health Service Medical Center in Seoul with randomized allocation and standardized outcome monitoring.
Who should consider this trial
Good fit: Adult men (≥18 years) scheduled for their first transrectal ultrasound-guided prostate biopsy who can consent and manage anticoagulant/antiplatelet therapy as required are ideal candidates.
Not a fit: Patients with uncorrectable bleeding disorders, active urinary tract infection, acute anorectal conditions, or inability to stop/adjust anticoagulation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, routine short probe compression could reduce rates of post-biopsy hematuria, rectal bleeding, and possibly lower subsequent infection risk.
How similar studies have performed: Small case series and nonrandomized reports suggest short probe compression can achieve hemostasis and one randomized report showed reduced intraprostatic hematoma on MRI after five minutes of digital rectal compression, but no randomized trials have focused on clinical bleeding or infection outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul, Seoul
- VHS medical center — Seoul, Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.