TENS During Transperineal Prostate Biopsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorMedical University of Gdansk
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
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 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Active TENSExperimental treatment 1 intervention
Group B: Sham TENSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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). The participant self-records the score on a paper form on a clipboard, within 30 seconds of the operator announcing completion of the block in fixed wording, and before the next procedural stage begins. The operator is blinded to allocation and asks no question about pain. A standardised explanation of the NRS and of the form is given to every participant before the procedure.
Time frame
Immediately after completion of periprostatic nerve block (intraoperative)Secondary outcomes
1
NRS Pain Score During Ultrasound Probe Insertion
NRS (0-10) assessed within 30 seconds of probe placement, before local anaesthesia administration begins.
Time frame
Immediately after ultrasound probe insertion (intraoperative)2
NRS Pain Score During Perineal Infiltration
NRS (0-10) assessed within 30 seconds of completion of perineal skin and subcutaneous tissue local anaesthetic infiltration.
Time frame
Immediately after perineal infiltration (intraoperative)3
NRS Pain Score During Biopsy Sampling
NRS (0-10) assessed within 30 seconds of the last biopsy core being obtained.
Time frame
Immediately after fusion-targeted biopsy sampling (intraoperative)4
Procedural Safety and Tolerability
Incidence and severity of adverse events classified per Clavien-Dindo grading system.
Time frame
Through 30-day follow-upOther outcomes
1
Preoperative state anxiety (State-Trait Anxiety Inventory - State subscale, STAI-S)
State anxiety assessed once before the procedure using the State subscale of the State-Trait Anxiety Inventory (STAI-S; Spielberger et al., 1983; validated Polish adaptation by Wrześniewski, Sosnowski, Jaworowska \& Fecenec, Pracownia Testów Psychologicznych). The STAI-S comprises 20 items rated 1-4; total score ranges from 20 to 80, with higher scores indicating greater state anxiety. Reported as the mean score per arm.
Time frame
Administered before the procedure.2
NRS-Anxiety
NRS-Anxiety (0-10; single item: "How anxious are you right now?"). Administered before the procedure and immediately after biopsy sampling to assess pre-to-post procedural anxiety change. Pre-to-post delta reported as exploratory outcome.
Time frame
Administered before the procedure and immediately after biopsy sampling to assess pre-to-post procedural anxiety change.3
Pain Catastrophizing Scale (PCS-13)
Pain Catastrophizing Scale (Sullivan et al., Psychol Assess 1995;7:524-532). 13-item self-report questionnaire, score 0-52. Three subscales: rumination, magnification, helplessness. Polish version available. Administered before the procedure as covariate for primary outcome analysis.
Time frame
Before the procedure4
TENS Amplitude vs Pain Reduction
Actual TENS amplitude used (mA) recorded for each participant in the active group. Spearman correlation between amplitude and NRS reduction during PNB.
Time frame
Intraoperative (active group only)Sponsors and contacts
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Source ClinicalTrials.gov