TENS During Transperineal Prostate Biopsy
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni w wieku 40 lat lub starsi
- •Podwyższony wynik PSA we krwi lub nieprawidłowe badanie prostaty
- •Podejrzana zmiana w rezonansie magnetycznym (wynik PI-RADS 3 lub wyżej)
- •Zaplanowana biopsja prostaty pod znieczuleniem lokalnym
- •Możliwość podpisania zgody na uczestnictwo
✗ Disqualifies
- •Wcześniejsze leczenie raka prostaty (operacja, radioterapia lub hormonalna)
- •Kardiorespiratory (rozrusznik serca, zaburzenia rytmu serca)
- •Aktywne zapalenie dróg moczowych lub zaburzenia krwawienia
- •Alergia na znieczulenie lokalne
- •Poważne problemy zdrowotne zagrażające bezpieczeństwu procedury
- •Nieumiejętność wypełniania ankiet
Simplified criteria — AI translation
Trial details
- Minimum age
- 40 Years
- Last updated (source)
- August 13, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Department of Urology, Medical University of Gdansk
Gdansk, Poland
Trial contact
Bartłomiej Marczak, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/14/2026.
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