TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial
NCT: NCT07578324 · NOT_YET_RECRUITING
Brief 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, the operating urologist, nor the nurse recording pain scores will know which group the participant is in. 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.
Frequently Asked Questions
What is TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial?
TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial is a clinical trial registered under NCT07578324. Current status: NOT_YET_RECRUITING.
What is the status of NCT07578324?
The current status of NCT07578324 (TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial) is: NOT_YET_RECRUITING.
When did TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial start?
TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial started on 2026-06.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.