Prostate Cancer (Diagnosis), Prostate Biopsy, Pain, Procedural
Conditions
Keywords
Transcutaneous Electrical Nerve Stimulation, TENS, Transperineal Prostate Biopsy, Local Anaesthesia, Periprostatic Nerve Block, Pain Management, MRI-Ultrasound Fusion Biopsy, Randomized Controlled Trial
Brief summary
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
DEVICETranscutaneous 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.
Identical electrode placement to active group. Device activated without delivering electrical current. Indistinguishable from active TENS by participant, operator, and outcome assessor.
Sponsors
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Triple-blind design. Participant blinding: identical electrode placement; device produces no sound and display is not visible. Care Provider (operating urologist) blinding: amplitude titration completed before operator enters room; opaque physical screen between device and operative field throughout procedure. Outcomes Assessor (Nurse B) blinding: independent nurse with no access to randomization list records all NRS scores. Investigator blinding: statistician receives data coded A/B until analysis lock. Only Nurse A (device operator) knows allocation.
Intervention model description
Two parallel groups (1:1 allocation ratio): active TENS plus standard local anaesthesia versus sham TENS plus standard local anaesthesia.
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain Score During Periprostatic Nerve Block | Immediately after completion of periprostatic nerve block (intraoperative) | 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). NRS assessed verbally by an independent outcome assessor (Nurse B) within 30 seconds of completion of the PNB injection, before the next procedural stage begins. Standardised verbal NRS explanation provided to all participants before the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS-Anxiety | Administered before the procedure and immediately after biopsy sampling to assess pre-to-post procedural anxiety change. | 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. |
| TENS Amplitude vs Pain Reduction | Intraoperative (active group only) | Actual TENS amplitude used (mA) recorded for each participant in the active group. Spearman correlation between amplitude and NRS reduction during PNB. |
| Pain Catastrophizing Scale (PCS-13) | Before the procedure | 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. |
| Patient Satisfaction | Immediately after procedure | Single-item Likert scale (1-5, where 1 = very dissatisfied and 5 = very satisfied), recorded immediately after procedure by independent outcome assessor. |
| NRS Pain Score During Ultrasound Probe Insertion | Immediately after ultrasound probe insertion (intraoperative) | NRS (0-10) assessed within 30 seconds of probe placement, before local anaesthesia administration begins. |
| NRS Pain Score During Perineal Infiltration | Immediately after perineal infiltration (intraoperative) | NRS (0-10) assessed within 30 seconds of completion of perineal skin and subcutaneous tissue local anaesthetic infiltration. |
| NRS Pain Score During Biopsy Sampling | Immediately after fusion-targeted biopsy sampling (intraoperative) | NRS (0-10) assessed within 30 seconds of the last biopsy core being obtained. |
| Procedural Safety and Tolerability | Through 30-day follow-up | Incidence and severity of adverse events classified per Clavien-Dindo grading system. |
| Willingness to Repeat the Procedure | 30-day follow-up visit | Single question (yes/no/unsure) assessing patient willingness to undergo the same procedure in the future. |
| Blinding Integrity - James Blinding Index | Immediately after biopsy sampling, before unblinding | Participant blinding assessed by single question posed by independent outcome assessor immediately after biopsy sampling: which group the participant believes they were assigned to (active/sham/no opinion), plus certainty rating (1-5). |
| Amsterdam Preoperative Anxiety and Information Scale | Administered before the procedure. | Amsterdam Preoperative Anxiety and Information Scale (APAIS; 6 items; Moerman et al., Anesth Analg 1996;82: 445-451; Polish forward-backward translation). Administered before the procedure. Association with primary outcome assessed by Spearman correlation as covariate. |
| Operator Satisfaction | Immediately after procedure | Single-item Likert scale (1-5, where 1 = very dissatisfied and 5 = very satisfied with procedural conditions), recorded by the operating urologist immediately after the procedure, assessing overall satisfaction with procedural conditions during the biopsy. |
Countries
Poland
Contacts
CONTACTBartłomiej Marczak, MD
Outcome results
None listed