TENS During Transperineal Prostate Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Electrical Nerve Stimulation (TENS), Sham Transcutaneous Electrical Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Diagnosis), Prostate Biopsy, Pain, Procedural. Basic parameters: from 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcutaneous Electrical Nerve Stimulation as an Adjunct to Local Anaesthesia During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: A Randomized Triple-Blind Sham-Controlled Trial
Overview
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.
Detailed description
This is a single-centre, prospective, randomized, triple-blind, sham-controlled, two-parallel-group superiority trial. The study builds on a preceding pilot study (TENS 1, n=84) which demonstrated large effect sizes for TENS-associated pain reduction during transperineal prostate biopsy under local anaesthesia.
Triple-blinding is achieved through a three-component procedure: amplitude titration is completed before the operating urologist enters the procedure room; a physical opaque screen is placed between the TENS device and the operative field; and participants are instructed not to verbalise device-related sensations during the procedure.
The primary outcome is NRS pain score during periprostatic nerve block, assessed within 30 seconds of completion of bilateral periprostatic infiltration by an independent outcome assessor blinded to allocation.
Exploratory outcomes include preoperative pain catastrophizing, preoperative anxiety (STAI-S), and the effect of prior biopsy experience on procedural pain.
Interventions
- Device Transcutaneous Electrical Nerve Stimulation (TENS)
Cefar 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. - Device Sham Transcutaneous Electrical Nerve Stimulation
Identical electrode placement to active group. Device activated without delivering electrical current. Indistinguishable from active TENS by participant, operator, and outcome assessor.
Primary outcome measures
- NRS Pain Score During Periprostatic Nerve Block [Time frame: Immediately after completion of periprostatic nerve block (intraoperative)]
Secondary outcome measures (8)
- NRS Pain Score During Ultrasound Probe Insertion [Time frame: Immediately after ultrasound probe insertion (intraoperative)]
- NRS Pain Score During Perineal Infiltration [Time frame: Immediately after perineal infiltration (intraoperative)]
- NRS Pain Score During Biopsy Sampling [Time frame: Immediately after fusion-targeted biopsy sampling (intraoperative)]
- Procedural Safety and Tolerability [Time frame: Through 30-day follow-up]
- Willingness to Repeat the Procedure [Time frame: 30-day follow-up visit]
- Blinding Integrity - James Blinding Index [Time frame: Immediately after biopsy sampling, before unblinding]
- Operator Satisfaction [Time frame: Immediately after procedure]
- Patient Satisfaction [Time frame: Immediately after procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Poland · 1 center
- Department of Urology, Medical University of Gdansk — Gdansk
Identifiers
NCT: NCT07578324 · TENS2-TPB-RCT-2026