AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

This study evaluates whether transcutaneous electrical nerve stimulation applied at specific acupuncture points (AcuTENS) can reduce pain and anxiety during transrectal ultrasound-guided prostate biopsy for participants suspected of prostate cancer. Many patients experience significant discomfort despite the use of periprostatic nerve block (PPNB). The aim of this study is to determine whether AcuTENS provides additional pain relief or anxiety reduction beyond standard analgesia. The findings may help identify a simple, low-risk adjunct that can improve patient comfort during prostate biopsy. AcuTENS is a non-invasive technique that delivers mild electrical stimulation through the skin, targeting acupuncture points believed to modulate pain perception. In this randomized, double-blind, placebo-controlled trial, participants are assigned to receive either active AcuTENS or a placebo TENS device that produces no therapeutic stimulation . All participants with receive routine care, including PPNB, according to institutional protocol. Pain scores, anxiety levels, vital signs, and patient satisfaction are recorded before, during, and after the biopsy.

NCT Number	NCT07292337
Lead Sponsor	University of Malaya
Conditions	Prostate Cancer, Procedural Pain Relief, TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY, Transcutaneous Electrical Nerve Stimulation
Enrollment	53 participants
Start Date	2024-12-01
Primary Completion	2025-08-30 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-24