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

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

Male participants only. Eligibility is limited to individuals assigned male at birth due to the requirement for a prostate.

Individual participant data (IPD) to be shared will include:

De-identified participant-level data relevant to primary and secondary outcome measures

Pain score responses at each procedural stage (Numeric Rating Scale data)

Group assignment (active TENS, sham TENS, or control)

Adverse event data (Clavien-Dindo classification)

Demographic and baseline clinical data (age, PSA level, BMI, prostate volume)

No identifying information (e.g., names, birth dates, or hospital IDs) will be shared.

IPD and related documents will be available immediately after publication and will remain available for 5 years.

Access will be granted to researchers with methodologically sound proposals for use in meta-analyses or individual participant data analyses. Data will be shared via a secure institutional repository after review and approval by the corresponding author.