MedTrace Logo

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

NCT07578324 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-11

No results posted yet for this study

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

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

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.

DEVICE

Sham Transcutaneous Electrical Nerve Stimulation

Identical electrode placement to active group. Device activated without delivering electrical current. Indistinguishable from active TENS by participant, operator, and outcome assessor.

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578324 on ClinicalTrials.gov