TENS for Pain Relief During Fusion-Guided Prostate Biopsy

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

Interventions

DEVICE

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.

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.

PROCEDURE

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.

Sponsors & Collaborators

• Medical University of Gdansk

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2025-05-30

Completion

2025-07-30

Countries

• Poland

Study Locations