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.
Male patients aged 40 years or older
Indication for prostate biopsy: elevated serum PSA (as per institutional protocol and EAU guidelines) or abnormal digital rectal examination (DRE)
Suspicious lesion on multiparametric MRI classified as PI-RADS score 3 or higher (version 2.1)
Scheduled for transperineal MRI-ultrasound fusion-guided prostate biopsy under local anaesthesia
Prior treatment for prostate cancer (surgical, radiotherapy, hormonal or focal therapy)
Contraindications to TENS: cutaneous damage or dermatologic conditions at electrode application sites; cardiac pacemaker or implantable cardioverter-defibrillator (ICD); uncontrolled cardiac arrhythmia or congestive heart failure; history of epilepsy or seizure disorder; metallic implants near the stimulation site; malignancy at or near the stimulation site
Contraindications to transperineal biopsy: active urinary tract infection; bleeding disorder or ongoing anticoagulation not amendable to bridging; anatomical abnormalities preventing safe prostatic access
Known allergy or intolerance to local anaesthetic agents or biopsy-related materials
Parallel
Transcutaneous Electrical Nerve Stimulation (TENS)
DeviceCefar Rehab X2 device (Class II, Type BF). Symmetrical biphasic compensated pulse; 80 Hz; 180 µs pulse duration; amplitude individually titrated. Two pairs of 5x5 cm electrodes in perineal region. Initiated 3-5 minutes before local anaesthesia, continued throughout procedure.
Sham Transcutaneous Electrical Nerve Stimulation
DeviceIdentical electrode placement to active group. Device activated without delivering electrical current. Indistinguishable from active TENS by participant, operator, and outcome assessor.
NRS Pain Score During Periprostatic Nerve Block
Patient-reported pain intensity during periprostatic nerve block (PNB), assessed using a Numeric Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain). PNB consists of periprostatic infiltration ( 10 mL 1% lignocaine under real-time ultrasound guidance). NRS assessed verbally by an independent outcome assessor (Nurse B) within 30 seconds of completion of the PNB injection, before the next procedural stage begins. Standardised verbal NRS explanation provided to all participants before the procedure.
NRS Pain Score During Ultrasound Probe Insertion
NRS (0-10) assessed within 30 seconds of probe placement, before local anaesthesia administration begins.
NRS Pain Score During Perineal Infiltration
NRS (0-10) assessed within 30 seconds of completion of perineal skin and subcutaneous tissue local anaesthetic infiltration.
NRS Pain Score During Biopsy Sampling
NRS (0-10) assessed within 30 seconds of the last biopsy core being obtained.
Procedural Safety and Tolerability
Incidence and severity of adverse events classified per Clavien-Dindo grading system.
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