AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

Transrectal ultrasound-guided prostate biopsy is the standard diagnostic procedure for suspected prostate cancer. Despite routine analgesic strategies such as periprostatic nerve block, many patients continue to experience moderate pain and procedure-related anxiety. AcuTENS, a form of transcutaneous electrical nerve stimulation applied to acupuncture points, has shown potential benefits in chronic pain conditions, osteoarthritis, and procedural discomfort in small-scale studies. Its proposed mechanism involves activation of peripheral nerve fibers, endogenous opioid pathways, and autonomic modulation, leading to reduced pain perception and improved relaxation. However, high-quality randomized controlled data for its use during prostate biopsy are limited. This study is a randomized, double-blind, placebo-controlled clinical trial conducted at University Malaya Medical Centre. The trial consists of two arms: 1. Active AcuTENS: Electrical stimulation applied to predetermined acupuncture points before and during the biopsy. 2. Placebo TENS: Identical device with no therapeutic electrical output. An initial pilot phase involving 10 patients demonstrated that AcuTENS was feasible, safe, and potentially beneficial. This informed the development of the current definitive trial, which includes 53 participants. All participants undergo the standard TRUS-guided prostate biopsy with local anesthesia using PPNB. Pain (VAS), anxiety (standardized scales), heart rate, blood pressure, and patient satisfaction are assessed at predefined time points. The primary outcome is assessment of pain during insertion of ultrasound probe, injection of local anaesthesia and pain during collection of biopsy. Secondary outcomes include anxiety reduction, hemodynamic stability, satisfaction scores, and any adverse effects related to TENS use. This investigation aims to determine whether AcuTENS offers meaningful improvement in patient comfort during prostate biopsy. If effective, it could be incorporated into routine practice as a simple, safe, and affordable adjunct to existing analgesic measures.