RecruitingNot ApplicableNCT07578324

TENS During Transperineal Prostate Biopsy

Transcutaneous Electrical Nerve Stimulation as an Adjunct to Local Anaesthesia During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: A Randomized Triple-Blind Sham-Controlled Trial


Sponsor

Medical University of Gdansk

Enrollment

140 participants

Start Date

Aug 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Transperineal prostate biopsy is a safe and effective method of diagnosing prostate cancer. When performed under local anaesthesia in an outpatient setting, it can cause significant pain, particularly during the periprostatic nerve block - the injection of local anaesthetic around the prostate. Better pain management during this procedure may improve patient comfort and encourage wider use of the transperineal approach. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, low-cost method of pain relief that works by delivering mild electrical impulses through the skin. A preceding pilot study at our centre (n=84) found that TENS used alongside local anaesthesia was associated with significantly lower pain scores during periprostatic nerve block and biopsy sampling, with no device-related complications. This study aims to confirm these findings in a larger, formally powered, triple-blind, randomized controlled trial. Participants will be randomly assigned to receive either active TENS or sham TENS (electrodes applied but no electrical current delivered) in addition to standard local anaesthesia. Neither the participant nor the operating urologist will know which group the participant is in. Pain scores are written down by the participant himself, so nobody asks him for a number during the procedure. Stimulation may feel strong, weak or not noticeable at all, and feeling nothing does not mean a participant is in the inactive group. Pain intensity will be assessed at four stages of the procedure using a 0-10 numeric rating scale. Participants will be followed up at 30 days after the biopsy.


Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham Transcutaneous Electrical Nerve Stimulation and a medical device called Transcutaneous Electrical Nerve Stimulation (TENS) for people with pain, procedural, prostate biopsy, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous Electrical Nerve Stimulation (TENS)

Cefar Rehab X2 device (Class II, Type BF). Symmetrical biphasic compensated pulse; 80 Hz; 180 µs pulse duration; amplitude individually titrated. Two 5x5 cm electrodes in perineal region. Initiated 3-5 minutes before local anaesthesia, continued throughout procedure.

DEVICESham Transcutaneous Electrical Nerve Stimulation

Identical electrode placement to active group. Device activated without delivering electrical current. Indistinguishable from active TENS by participant, operator, and outcome assessor.


Locations(1)

Department of Urology, Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, Poland

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NCT07578324


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