Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Shocking pain away: TENS device tested for prostate biopsy discomfort

NCT ID NCT07331246

Symptom relief Sponsor: Medical University of Gdansk Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a TENS device, which uses mild electrical pulses, can reduce pain during a prostate biopsy. 84 men were randomly assigned to receive TENS plus local anesthetic, a sham TENS device plus local anesthetic, or local anesthetic alone. Participants reported their pain levels at several points during the procedure. The goal is to find a simple, non-drug way to make biopsies more comfortable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous electrical nerve stimulation (TENS) device
What this could lead to
If it works, TENS could offer a simple, drug-free way to reduce pain during prostate biopsies.
What could go wrong
This is a small, single-center exploratory study. The results may not apply to all patients, and TENS might not provide meaningful pain relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

84 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Fusion biopsy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

agnosia prostate cancer tarsal coalition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fusion biopsy Pain management Prostate biopsy Prostate cancer

Contacts and locations

Locations

  • Department of Urology, Medical University of Gdansk

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.