TENS for Pain Relief During Fusion-Guided Prostate Biopsy (NCT07331246) | Clinical Trial Compass
CompletedNot Applicable
TENS for Pain Relief During Fusion-Guided Prostate Biopsy
Poland84 participantsStarted 2023-12-01
Plain-language 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
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity during transperineal prostate biopsy
Timeframe: Immediately after each procedural stage (within 30 seconds)