Skip to main content
OpenTrials
Completed

NCT Number: NCT07331246

TENS for Pain Relief During Fusion-Guided Prostate Biopsy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Agnosia Fusion Biopsy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Prostate Biopsy Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: TENS Therapy, Electrical Nerve Stimulation

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.

Other names: Sham TENS, Placebo TENS, Inactive Electrical Stimulation

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.

Other names: Perineal Infiltration and Periprostatic Nerve Block, Standard Transperineal Local Anesthesia

Primary outcomes

  1. Pain intensity during transperineal prostate biopsy

    Time frame: Immediately after each procedural stage (within 30 seconds)

    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.

Secondary outcomes

  1. Incidence of adverse events related to biopsy or TENS application

    Time frame: Up to 30 days after biopsy

    All adverse events will be recorded, including skin irritation, discomfort, bleeding, urinary retention, or infection. Events will be classified using the Clavien-Dindo system.

  2. Participant perception of TENS activity (blinding assessment)

    Time frame: Immediately after the procedure

    After the procedure, participants in the TENS or sham groups will be asked whether they believed the TENS device was active. Responses will be used to evaluate the effectiveness of participant blinding.

  3. Correlation between number of biopsy cores and pain score

    Time frame: Immediately after biopsy sampling

    Spearman correlation will be used to assess whether the number of biopsy cores taken per lesion is associated with increased patient-reported pain during the sampling phase of the biopsy procedure.

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: An Exploratory Single-Center, Randomized, Placebo-Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.