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TENS During Transperineal Prostate Biopsy

Study acronym: TENS 2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jan 2027 → Apr 2027
See other at-risk trials from Medical University of Gdansk

Record History

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  1. Notable Recruitment openedv3 Show 4 more changesShow less
    • Start date changed from estimate of Aug 2026 to Aug 12, 2026
    • Secondary endpoints: 8 to 10
    • Study description expanded, about 380 words
    • Site details revised
  2. Notable Start date: Jun 2026 to Aug 2026v2 Show 4 more changesShow less
    • Primary completion pushed from Jan 2027 to Apr 2027
    • Study completion pushed from Feb 2027 to May 2027
    • Secondary endpoints: 12 to 8
    • Study title shortened, about 10 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 nor the operating urologist will know which group the participant is in. Pain scores are written down by the participant himself, so nobody asks him for a number during the procedure. Stimulation may feel strong, weak or not noticeable at all, and feeling nothing does not mean a participant is in the inactive group. 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.
Trial Details
NCT Number NCT07578324
Lead Sponsor Medical University of Gdansk
Conditions
(from sponsor)
Prostate Cancer (Diagnosis), Prostate Biopsy, Pain, Procedural
Related terms Agnosia, Disease, Procedural Pain, Prostatic Neoplasms
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov