TENS During Transperineal Prostate Biopsy
Recruiting · NCT07578324 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Ability to provide written informed consent
Exclusion criteria
- 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
- Severe comorbidities or unstable medical condition compromising procedural safety
- Inability to complete questionnaires
- Participation in another interventional clinical trial within 30 days prior to enrolment
Where it is running
1 location listed.
- Department of Urology, Medical University of Gdansk - Gdansk, Pomeranian Voivodeship, Poland