AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy

NCT07292337 | Active Not Recruiting DMC

• 1 other identifier: UMG012C-2024
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Procedural Pain Relief; TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY; Transcutaneous Electrical Nerve Stimulation

Keywords

Transcutaneous electrical nerve stimulation; TRUS-guided prostate biopsy; Pain control and anxiety management during procedure

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy pain relief of application of Acu-TENS in TRUS prostate biopsy

  Pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated pain measurement tool ranging from 0 to 10, where: 0 = no pain 10 = worst pain imaginable Higher scores indicate greater pain intensity.

  VAS scores will be recorded in real time at the moment of maximal discomfort during: Insertion of the transrectal ultrasound probe Injection of periprostatic local anaesthesia Prostate biopsy sampling Time Frame: Immediately during the procedure

Secondary Outcomes (1)

• To evaluate anxiety levels of subjects undergoing TRUS biopsy with application of Acu-TENS

  STAI scores will be measured: 1. Before the biopsy 2. Immediately after completion of the biopsy Time Frame: Pre-procedure and immediately post-procedure

Study Arms (2)

Active AcuTENS

EXPERIMENTAL

Participants receive active transcutaneous electrical nerve stimulation applied to selected acupuncture points before and during TRUS-guided prostate biopsy, in addition to standard periprostatic nerve block.

Device: Active AcuTENS

Placebo TENS

PLACEBO COMPARATOR

Participants receive a identical TENS device with a placebo setting and no therapeutic electrical output, applied to the same acupuncture points before and during TRUS-guided prostate biopsy, in addition to standard periprostatic nerve block.

Device: Placebo TENS

Interventions

Active AcuTENS DEVICE

Electrical stimulation delivered via surface electrodes placed on predefined acupuncture points. Stimulation is applied before and during the biopsy using a device capable of therapeutic current output.

Active AcuTENS

Placebo TENS DEVICE

An identical TENS device set to a placebo setting with no active electrical output. Electrodes are applied to the same acupuncture points, with no therapeutic stimulation.

Placebo TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consented for first time TRUS prostate biopsy.
• Patient aged 18 years and above.

You may not qualify if:

• Patient with previous experience of TRUS biopsy
• Patient with pacemakers or automatic cardiac defibrillator implant or implant in the upper limb
• Patient with cutaneous skin breaks on application sites (e.g wound, burn scar)
• Patient diagnosed to have epilepsy or impaired mental state or anxiety disorder
• Patient with known allergy to acupuncture patch or lidocaine spray

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (2)

• Nazir B. Pain during transrectal ultrasound-guided prostate biopsy and the role of periprostatic nerve block: what radiologists should know. Korean J Radiol. 2014 Sep-Oct;15(5):543-53. doi: 10.3348/kjr.2014.15.5.543. Epub 2014 Sep 12.

  PMID: 25246816 RESULT

• Ouzounidis X, Moysidis K, Kalinderis N, Papanikolaou D, Koukourikis P, Papaefstathiou E, Hatzimouratidis K. Efficacy and safety of three different analgesic methods for patients undergoing transrectal ultrasound-guided prostate biopsy: a prospective, randomized controlled trial. Hippokratia. 2020 Oct-Dec;24(4):166-172.

  PMID: 35023892 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Novinth Kumar A/L Raja Ram, MBBS, MS (Gen Surg)

  Department of Surgery (Urology Unit), University Malaya Medical Centre, Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and all study personnel, including clinicians performing the biopsy and assessors recording outcomes, are blinded to group allocation. Intervention devices are identical in appearance.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Team member

Model Details: Randomized 1:1 parallel-group design comparing interventional group using active AcuTENS with placebo TENS during TRUS-guided prostate biopsy.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: December 1, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)