TENS for Pain Relief During Fusion-Guided Prostate Biopsy

Medical University of Gdansk

Status: Completed

Conditions: Prostate Biopsy; Pain Management; Prostate Cancer; Fusion Biopsy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07331246

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

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

84 participants in 3 patient groups, including a placebo group

A. Local Anesthesia Only (Control Group)

Active Comparator group

Description:

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

Treatment:

Procedure: Local Anesthesia

B. TENS + Local Anesthesia

Experimental group

Description:

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

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Procedure: Local Anesthesia

C. Sham TENS + Local Anesthesia

Placebo Comparator group

Description:

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

Treatment:

Device: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)

Procedure: Local Anesthesia