TENS for Pain Relief During Fusion-Guided Prostate Biopsy

NCT ID: NCT07331246

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

A. Local Anesthesia Only (Control Group)

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

Group Type: ACTIVE_COMPARATOR

Local Anesthesia

Intervention Type: 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.

B. TENS + Local Anesthesia

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

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: 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.

Local Anesthesia

Intervention Type: 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.

C. Sham TENS + Local Anesthesia

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

Group Type: PLACEBO_COMPARATOR

Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)

Intervention Type: 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.

Local Anesthesia

Intervention Type: 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.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS)

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.

Intervention Type: DEVICE

Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)

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.

Intervention Type: DEVICE

Local Anesthesia

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.

Intervention Type: PROCEDURE

Other Intervention Names

TENS Therapy; Electrical Nerve Stimulation; Sham TENS; Placebo TENS; Inactive Electrical Stimulation; Perineal Infiltration and Periprostatic Nerve Block; Standard Transperineal Local Anesthesia

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Bartłomiej Marczak

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Urology, Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, Poland

Countries

Poland

Other Identifiers

KB/531/2023, KB/531-116/2025

Identifier Type: -

Identifier Source: org_study_id