TENS for Pain Relief During Fusion-Guided Prostate Biopsy

NCT07331246 | Completed

• 1 other identifier: KB/531/2023, KB/531-116/2025
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether transcutaneous electrical nerve stimulation (TENS) can reduce pain during transperineal prostate biopsy in adult male patients. It will also assess the safety and tolerability of using TENS in this setting. The main questions it aims to answer are: Does TENS lower patient-reported pain during local anesthesia and prostate biopsy sampling? Are there any side effects or complications associated with using TENS during the procedure? Researchers will compare TENS to a placebo (sham TENS with no active stimulation) and to standard care (local anesthesia alone). Participants will: Be randomly assigned to receive either TENS + local anesthesia, sham TENS + local anesthesia, or local anesthesia alone Undergo a standard transperineal prostate biopsy guided by MRI-ultrasound fusion Report their pain levels during four specific stages of the procedure Attend a follow-up visit 3-4 weeks after the biopsy to review results and assess for any side effects

Conditions

Prostate Cancer; Prostate Biopsy; Fusion Biopsy; Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain intensity during transperineal prostate biopsy

  Pain will be measured using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at four key stages of the procedure: (1) ultrasound probe insertion, (2) perineal skin infiltration, (3) peri-prostatic nerve block, and (4) biopsy sampling.

  Immediately after each procedural stage (within 30 seconds)

Secondary Outcomes (3)

• Incidence of adverse events related to biopsy or TENS application

  Up to 30 days after biopsy

• Participant perception of TENS activity (blinding assessment)

  Immediately after the procedure

• Correlation between number of biopsy cores and pain score

  Immediately after biopsy sampling

Study Arms (3)

A. Local Anesthesia Only (Control Group)

ACTIVE COMPARATOR

Participants receive standard local anesthesia for transperineal MRI-ultrasound fusion-guided prostate biopsy using 1% lignocaine (20 mL total). No additional intervention is applied.

Procedure: Local Anesthesia

B. TENS + Local Anesthesia

EXPERIMENTAL

Participants receive transcutaneous electrical nerve stimulation (TENS) applied to the perineum in addition to standard local anesthesia.

Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: Local Anesthesia

C. Sham TENS + Local Anesthesia

PLACEBO COMPARATOR

Participants receive sham (inactive) TENS with standard local anesthesia. Electrodes are applied as in Group B, but no electrical stimulation is delivered.

Device: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS); Procedure: Local Anesthesia

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Application of transcutaneous electrical nerve stimulation (TENS) using two pairs of adhesive electrodes placed in the perineal region. Electrical stimulation was initiated 3-5 minutes before local anesthetic infiltration and continued throughout the biopsy procedure. The device used symmetrical biphasic pulses at 80 Hz with a pulse width of 180 μs. Amplitude was adjusted to the maximum comfortable level for each participant. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure.

Also known as: TENS Therapy, Electrical Nerve Stimulation

B. TENS + Local Anesthesia

Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS) DEVICE

Application of sham transcutaneous electrical nerve stimulation (TENS) using identical electrode placement and device setup as the active TENS group, but without delivery of electrical current. The device was powered on but modified to prevent active stimulation. Participants were not informed of the inactive nature of the intervention. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure.

Also known as: Sham TENS, Placebo TENS, Inactive Electrical Stimulation

C. Sham TENS + Local Anesthesia

Local Anesthesia PROCEDURE

Administration of 1% lignocaine (20 mL total) using a full needle path technique for anesthesia of the perineal skin and periprostatic tissue. No TENS electrodes or placebo stimulation applied. This represents standard of care anesthesia during transperineal MRI-ultrasound fusion-guided prostate biopsy.

Also known as: Perineal Infiltration and Periprostatic Nerve Block, Standard Transperineal Local Anesthesia

A. Local Anesthesia Only (Control Group); B. TENS + Local Anesthesia; C. Sham TENS + Local Anesthesia

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Male participants only. Eligibility is limited to individuals assigned male at birth due to the requirement for a prostate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspicious lesions on multiparametric MRI, classified as PI-RADS score ≥ 3
• The indication for mpMRI was based on the presence of at least one of the following:
• Elevated serum prostate-specific antigen (PSA) levels
• Abnormal digital rectal examination (DRE)

You may not qualify if:

• Prior treatment of prostate cancer
• Contraindications to TENS, including:
• Cutaneous damage or dermatologic conditions at the TENS application sites
• Presence of cardiac pacemakers or automatic implantable cardioverter-defibrillators (AICDs)
• Uncontrolled cardiac arrhythmias or congestive heart failure
• History of epilepsy or seizure disorders
• Metal implants near the site of stimulation
• Malignancy at or near the site of stimulation
• Contraindications to transperineal biopsy, including:
• Active urinary tract infection
• Bleeding disorders or ongoing anticoagulant therapy
• Anatomical abnormalities that prevent safe access to the prostate
• Known allergy or intolerance to local anesthetics or biopsy-related materials
• Severe comorbidities or unstable medical conditions that could compromise procedural safety
• Inability to provide informed consent or refusal to sign the consent form

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; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation; Anesthesia, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: December 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and related documents will be available immediately after publication and will remain available for 5 years.
• Access Criteria: Access will be granted to researchers with methodologically sound proposals for use in meta-analyses or individual participant data analyses. Data will be shared via a secure institutional repository after review and approval by the corresponding author.

Locations

PL (1)