Fusion Biopsy, Pain Management, Prostate Biopsy, Prostate Cancer
Conditions
Brief 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
Interventions
DEVICETranscutaneous Electrical Nerve Stimulation (TENS)
Application of transcutaneous electrical nerve stimulation (TENS) using two pairs of adhesive electrodes placed in the perineal region. Electrical stimulation was initiated 3-5 minutes before local anesthetic infiltration and continued throughout the biopsy procedure. The device used symmetrical biphasic pulses at 80 Hz with a pulse width of 180 μs. Amplitude was adjusted to the maximum comfortable level for each participant. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure.
Application of sham transcutaneous electrical nerve stimulation (TENS) using identical electrode placement and device setup as the active TENS group, but without delivery of electrical current. The device was powered on but modified to prevent active stimulation. Participants were not informed of the inactive nature of the intervention. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure.
PROCEDURELocal Anesthesia
Administration of 1% lignocaine (20 mL total) using a full needle path technique for anesthesia of the perineal skin and periprostatic tissue. No TENS electrodes or placebo stimulation applied. This represents standard of care anesthesia during transperineal MRI-ultrasound fusion-guided prostate biopsy.
Sponsors
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during transperineal prostate biopsy | Immediately after each procedural stage (within 30 seconds) | Pain will be measured using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at four key stages of the procedure: (1) ultrasound probe insertion, (2) perineal skin infiltration, (3) peri-prostatic nerve block, and (4) biopsy sampling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events related to biopsy or TENS application | Up to 30 days after biopsy | All adverse events will be recorded, including skin irritation, discomfort, bleeding, urinary retention, or infection. Events will be classified using the Clavien-Dindo system. |
| Participant perception of TENS activity (blinding assessment) | Immediately after the procedure | After the procedure, participants in the TENS or sham groups will be asked whether they believed the TENS device was active. Responses will be used to evaluate the effectiveness of participant blinding. |
| Correlation between number of biopsy cores and pain score | Immediately after biopsy sampling | Spearman correlation will be used to assess whether the number of biopsy cores taken per lesion is associated with increased patient-reported pain during the sampling phase of the biopsy procedure. |
Countries
Poland
Outcome results
None listed