Clinical Trial

Intraprostatic Anesthesia During Transperineal Prostate Biopsy

Study acronym: PRO-PAIN
Active, Not Recruiting
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Summary
Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to undergo repeat biopsy when necessary. This prospective randomized controlled study aims to evaluate whether the addition of intraprostatic local anesthesia to standard perineal local anesthesia reduces pain during transperineal prostate biopsy. Fifty patients undergoing prostate biopsy under local anesthesia will be randomized into two groups. The first group will receive standard perineal local anesthesia, while the second group will receive additional intraprostatic local anesthesia. Pain severity will be assessed before, during, and after the procedure using a visual analog scale (VAS). Anxiety and depression levels will be evaluated preoperatively using the Hospital Anxiety and Depression Scale (HADS). Patient-related factors, procedural characteristics, and post-procedural outcomes will also be recorded to identify factors associated with pain perception. The results of this study may help optimize local anesthesia techniques and improve patient comfort during transperineal prostate biopsy.
Trial Details
NCT Number NCT07683182
Lead Sponsor Marmara University
Conditions Prostate Cancer (Diagnosis), Prostate-Specific Antigen
Enrollment 50 participants
Start Date 2025-11-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-06