TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial

NCT07578324 | Not Yet 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, 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.

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). 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.

  Immediately after completion of periprostatic nerve block (intraoperative)

Secondary Outcomes (12)

• 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

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 pairs of 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 pairs of 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

Location

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: 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.
• 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 (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

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)