Probe compression after transrectal prostate biopsy to reduce bleeding and infection
Official title: A Randomized Controlled Trial Evaluating the Effect of Routine Probe Compression After Transrectal Prostate Biopsy on Bleeding and Infectious Complications
Run by Veterans Health Service Medical Center, Seoul, Korea · NCT07550985 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 324 (estimated) |
| Sponsor | Veterans Health Service Medical Center, Seoul, Korea Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | December 20, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07550985 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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VHS medical center
Seoul, Seoul, South Korea Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.