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NCT07550985
Routine Probe Compression After Transrectal Prostate Biopsy(RPCAB) to Reduce Bleeding and Infectious Complications
Conditions: Prostate Biopsy, Post Biopsy Bleeding, Transrectal Ultrasound-guided Prostate Biopsy
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 324
Sponsor: Veterans Health Service Medical Center, Seoul, Korea
Location: VHS medical center Seoul Seoul
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07550985). StuddyBuddy aggregates publicly available trial information.