TENS During Transperineal Prostate Biopsy

NCT07578324 | Recruiting

• 1 other identifier: TENS2-TPB-RCT-2026
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer (Diagnosis); Prostate Biopsy; Pain, Procedural

Keywords

Transcutaneous Electrical Nerve Stimulation; TENS; Transperineal Prostate Biopsy; Local Anaesthesia; Periprostatic Nerve Block; Pain Management; MRI-Ultrasound Fusion Biopsy; Randomized Controlled Trial

Outcome Measures

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.

  Immediately after completion of periprostatic nerve block (intraoperative)

Secondary Outcomes (10)

• NRS Pain Score During Ultrasound Probe Insertion

  Immediately after ultrasound probe insertion (intraoperative)

• NRS Pain Score During Perineal Infiltration

  Immediately after perineal infiltration (intraoperative)

• NRS Pain Score During Biopsy Sampling

  Immediately after fusion-targeted biopsy sampling (intraoperative)

• Procedural Safety and Tolerability

  Through 30-day follow-up

• Willingness to Repeat the Procedure

  30-day follow-up visit

Other Outcomes (5)

• Preoperative state anxiety (State-Trait Anxiety Inventory - State subscale, STAI-S)

  Administered before the procedure.

• NRS-Anxiety

  Administered before the procedure and immediately after biopsy sampling to assess pre-to-post procedural anxiety change.

• Pain Catastrophizing Scale (PCS-13)

  Before the procedure

Study Arms (2)

Active TENS

EXPERIMENTAL

Participants receive active transcutaneous electrical nerve stimulation (TENS) initiated 3-5 minutes before local anaesthesia, using Cefar Rehab X2 device (Class II, Type BF). Parameters: symmetrical biphasic compensated pulse, 80 Hz, 180 µs pulse duration, amplitude individually titrated to highest comfortably tolerable level. Two 5x5 cm electrodes placed in the perineal region. TENS continued throughout all procedural stages and discontinued after biopsy sampling. Standard local anaesthesia administered to all participants: 10 mL 2% lignocaine gel transrectally, followed by 20 mL 1% lignocaine using full needle-path infiltration technique.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham TENS

SHAM COMPARATOR

Participants receive sham TENS. Electrodes placed identically to the active group. Device activated in identical manner but delivers no electrical current. Device display not visible to participant; device produces no sound. Standard local anaesthesia identical to active group.

Device: Sham Transcutaneous Electrical Nerve Stimulation

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Cefar 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.

Active TENS

Sham Transcutaneous Electrical Nerve Stimulation DEVICE

Identical electrode placement to active group. Device activated without delivering electrical current. Indistinguishable from active TENS by participant, operator, and outcome assessor.

Sham TENS

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Urology, Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease; Pain, Procedural; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Bartłomiej Marczak, MD

CONTACT

+48 790 710 909; bartlomiej.marczak@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded: participants; the operating urologist, who is also the PI (Care Provider, Investigator); the statistician. NRS scores are self-recorded by the participant on a paper form at moments cued by the blinded operator, so the outcome assessor is the blinded participant and no staff member asks for a score. Not blinded: one nurse, who opens the envelope and operates the device, records no outcomes and never handles the form. Participant: identical electrode placement and identical titration ritual in both arms (same dial sequence, pauses, wording; no current in sham); device silent; display not visible. Care Provider: titration completed before the operator enters the room; opaque screen between device and operative field; display taped; participants told not to comment on device sensation; the operator announces each stage in fixed wording and asks nothing about pain. Investigator: PI blinded to allocation; statistician receives data coded A/B.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist, Department of Urology

Model Details: Two parallel groups (1:1 allocation ratio): active TENS plus standard local anaesthesia versus sham TENS plus standard local anaesthesia.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 11, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning at time of publication, no end date.
• Access Criteria: Publicly available without restriction via Open Science Framework (OSF).

Locations

PL (1)