Clinical Trial

TENS for Pain Relief During Fusion-Guided Prostate Biopsy

Completed
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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
Trial Details
NCT Number NCT07331246
Lead Sponsor Medical University of Gdansk
Conditions Prostate Cancer, Prostate Biopsy, Fusion Biopsy, Pain Management
Enrollment 84 participants
Start Date 2023-12-01
Primary Completion 2025-05-30 (estimated)
Study Completion 2025-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-09