NCT07331246Completed
TENS for Pain Relief During Fusion-Guided Prostate Biopsy
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: An Exploratory Single-Center, Randomized, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 28 Dec 2025
- Start date
- 1 Dec 2023
- Primary completion date
- 30 May 2025
- Lead sponsor
- Medical University of Gdansk
- Diseases
- Prostate cancer
- NCT number
- NCT07331246
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 1 Dec 2023 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment of prostate cancer
Other illness
- 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
Other
- Inability to provide informed consent or refusal to sign the consent form
Who the study is looking for
- 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)
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Medical University of Gdansk Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.