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TENS During Transperineal Prostate Biopsy

RecruitingNAAges 40 Years - anyMaleMedical University of Gdansk
NCT07578324 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pow

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📋 Eligibility rules (as published)
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
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What it tests

  • Transcutaneous Electrical Nerve Stimulation (TENS)
  • Sham Transcutaneous Electrical Nerve Stimulation
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Where

1 site
Department of Urology, Medical University of Gdansk
Gdansk, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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