TENS to Reduce Pain During Transperineal Prostate Biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-centre, prospective, randomized, sham-controlled trial comparing active TENS with sham TENS during transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. Adults aged 40 and older with elevated PSA or abnormal DRE and MRI PI-RADS 3 or higher are enrolled. Participants receive either active TENS with local anesthesia or sham stimulation, with the goal of reducing pain during the nerve block and biopsy sampling. The study builds on a prior pilot showing large pain reductions with TENS and no device-related adverse events, and uses a formal power calculation to detect a clinically meaningful difference. All procedures are performed at a single institution to minimize variability, with standardized stimulation parameters and biopsy technique.

Why it matters

Who can join: the full rules

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's running

• Department of Urology, Medical University of Gdansk
  Gdansk, Pomeranian Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Bartłomiej Marczak, MD
• Email: bartlomiej.marczak@gumed.edu.pl
• Phone: +48 790 710 909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.