Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fusion Biopsy | — | UNRESOLVED | — |
| Pain Management | — | UNRESOLVED | — |
| Prostate Biopsy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Anesthesia | Procedure | — | UNRESOLVED |
| Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS) | Device | — | UNRESOLVED |
| Transcutaneous Electrical Nerve Stimulation (TENS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A. Local Anesthesia Only (Control Group)
- description
- Participants receive standard local anesthesia for transperineal MRI-ultrasound fusion-guided prostate biopsy using 1% lignocaine (20 mL total). No additional intervention is applied.
- interventionNames
- Procedure: Local Anesthesia
- type
- EXPERIMENTAL
- label
- B. TENS + Local Anesthesia
- description
- Participants receive transcutaneous electrical nerve stimulation (TENS) applied to the perineum in addition to standard local anesthesia.
- interventionNames
- Device: Transcutaneous Electrical Nerve Stimulation (TENS)
- Procedure: Local Anesthesia
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available