NCT07292337Active, not recruiting
AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy
Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) During Transrectal Ultrasound Guided (TRUS) Prostate Biopsy: A Randomized Double-blind Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 5 Dec 2025
- Start date
- 1 Dec 2024
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- University of Malaya
- Diseases
- Prostate cancer
- NCT number
- NCT07292337
What you commit to
- Study type: Interventional
- Participants enrolled: 53
- From 1 Dec 2024 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with previous experience of TRUS biopsy
Other illness
- Patient with pacemakers or automatic cardiac defibrillator implant or implant in the upper limb
- Patient diagnosed to have epilepsy or impaired mental state or anxiety disorder
- Patient with known allergy to acupuncture patch or lidocaine spray
Other
- Patient with cutaneous skin breaks on application sites (e.g wound, burn scar)
Who the study is looking for
- Patient consented for first time TRUS prostate biopsy.
- Patient aged 18 years and above.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Malaya Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.