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TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial (TENS 2)

5 mei 2026 bijgewerkt door: Bartłomiej Marczak, Medical University of Gdansk

Transcutaneous Electrical Nerve Stimulation as an Adjunct to Local Anaesthesia During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: A Randomized Triple-Blind Sham-Controlled Trial

Transperineal prostate biopsy is a safe and effective method of diagnosing prostate cancer. When performed under local anaesthesia in an outpatient setting, it can cause significant pain, particularly during the periprostatic nerve block - the injection of local anaesthetic around the prostate. Better pain management during this procedure may improve patient comfort and encourage wider use of the transperineal approach.

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, low-cost method of pain relief that works by delivering mild electrical impulses through the skin. A preceding pilot study at our centre (n=84) found that TENS used alongside local anaesthesia was associated with significantly lower pain scores during periprostatic nerve block and biopsy sampling, with no device-related complications.

This study aims to confirm these findings in a larger, formally powered, triple-blind, randomized controlled trial. Participants will be randomly assigned to receive either active TENS or sham TENS (electrodes applied but no electrical current delivered) in addition to standard local anaesthesia. Neither the participant, the operating urologist, nor the nurse recording pain scores will know which group the participant is in.

Pain intensity will be assessed at four stages of the procedure using a 0-10 numeric rating scale. Participants will be followed up at 30 days after the biopsy.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a single-centre, prospective, randomized, triple-blind, sham-controlled, two-parallel-group superiority trial. The study builds on a preceding pilot study (TENS 1, n=84) which demonstrated large effect sizes for TENS-associated pain reduction during transperineal prostate biopsy under local anaesthesia.

Triple-blinding is achieved through a three-component procedure: amplitude titration is completed before the operating urologist enters the procedure room; a physical opaque screen is placed between the TENS device and the operative field; and participants are instructed not to verbalise device-related sensations during the procedure.

The primary outcome is NRS pain score during periprostatic nerve block, assessed within 30 seconds of completion of bilateral periprostatic infiltration by an independent outcome assessor blinded to allocation.

Exploratory outcomes include preoperative pain catastrophizing, preoperative anxiety (STAI-S), and the effect of prior biopsy experience on procedural pain.

Studietype

Ingrijpend

Inschrijving (Geschat)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Polen
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-214
        • Department of Urology, Medical University of Gdansk
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Male patients aged 40 years or older
  • Indication for prostate biopsy: elevated serum PSA (as per institutional protocol and EAU guidelines) or abnormal digital rectal examination (DRE)
  • Suspicious lesion on multiparametric MRI classified as PI-RADS score 3 or higher (version 2.1)
  • Scheduled for transperineal MRI-ultrasound fusion-guided prostate biopsy under local anaesthesia
  • Ability to provide written informed consent

Exclusion Criteria:

  • Prior treatment for prostate cancer (surgical, radiotherapy, hormonal or focal therapy)
  • Contraindications to TENS: cutaneous damage or dermatologic conditions at electrode application sites; cardiac pacemaker or implantable cardioverter-defibrillator (ICD); uncontrolled cardiac arrhythmia or congestive heart failure; history of epilepsy or seizure disorder; metallic implants near the stimulation site; malignancy at or near the stimulation site
  • Contraindications to transperineal biopsy: active urinary tract infection; bleeding disorder or ongoing anticoagulation not amendable to bridging; anatomical abnormalities preventing safe prostatic access
  • Known allergy or intolerance to local anaesthetic agents or biopsy-related materials
  • Severe comorbidities or unstable medical condition compromising procedural safety
  • Inability to complete questionnaires
  • Participation in another interventional clinical trial within 30 days prior to enrolment

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active TENS
Participants receive active transcutaneous electrical nerve stimulation (TENS) initiated 3-5 minutes before local anaesthesia, using Cefar Rehab X2 device (Class II, Type BF). Parameters: symmetrical biphasic compensated pulse, 80 Hz, 180 µs pulse duration, amplitude individually titrated to highest comfortably tolerable level. Two pairs of 5x5 cm electrodes placed in the perineal region. TENS continued throughout all procedural stages and discontinued after biopsy sampling. Standard local anaesthesia administered to all participants: 10 mL 2% lignocaine gel transrectally, followed by 20 mL 1% lignocaine using full needle-path infiltration technique.
Apparaat: Transcutaneous Electrical Nerve Stimulation (TENS)
Cefar Rehab X2 device (Class II, Type BF). Symmetrical biphasic compensated pulse; 80 Hz; 180 µs pulse duration; amplitude individually titrated. Two pairs of 5x5 cm electrodes in perineal region. Initiated 3-5 minutes before local anaesthesia, continued throughout procedure.
Sham-vergelijker: Sham TENS
Participants receive sham TENS. Electrodes placed identically to the active group. Device activated in identical manner but delivers no electrical current. Device display not visible to participant; device produces no sound. Standard local anaesthesia identical to active group.
Apparaat: Sham Transcutaneous Electrical Nerve Stimulation
Identical electrode placement to active group. Device activated without delivering electrical current. Indistinguishable from active TENS by participant, operator, and outcome assessor.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
NRS Pain Score During Periprostatic Nerve Block
Tijdsspanne: Immediately after completion of periprostatic nerve block (intraoperative)
Patient-reported pain intensity during periprostatic nerve block (PNB), assessed using a Numeric Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain). PNB consists of periprostatic infiltration ( 10 mL 1% lignocaine under real-time ultrasound guidance). NRS assessed verbally by an independent outcome assessor (Nurse B) within 30 seconds of completion of the PNB injection, before the next procedural stage begins. Standardised verbal NRS explanation provided to all participants before the procedure.
Immediately after completion of periprostatic nerve block (intraoperative)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
NRS Pain Score During Ultrasound Probe Insertion
Tijdsspanne: Immediately after ultrasound probe insertion (intraoperative)
NRS (0-10) assessed within 30 seconds of probe placement, before local anaesthesia administration begins.
Immediately after ultrasound probe insertion (intraoperative)
NRS Pain Score During Perineal Infiltration
Tijdsspanne: Immediately after perineal infiltration (intraoperative)
NRS (0-10) assessed within 30 seconds of completion of perineal skin and subcutaneous tissue local anaesthetic infiltration.
Immediately after perineal infiltration (intraoperative)
NRS Pain Score During Biopsy Sampling
Tijdsspanne: Immediately after fusion-targeted biopsy sampling (intraoperative)
NRS (0-10) assessed within 30 seconds of the last biopsy core being obtained.
Immediately after fusion-targeted biopsy sampling (intraoperative)
Procedural Safety and Tolerability
Tijdsspanne: Through 30-day follow-up
Incidence and severity of adverse events classified per Clavien-Dindo grading system.
Through 30-day follow-up
Willingness to Repeat the Procedure
Tijdsspanne: 30-day follow-up visit
Single question (yes/no/unsure) assessing patient willingness to undergo the same procedure in the future.
30-day follow-up visit
Blinding Integrity - James Blinding Index
Tijdsspanne: Immediately after biopsy sampling, before unblinding
Participant blinding assessed by single question posed by independent outcome assessor immediately after biopsy sampling: which group the participant believes they were assigned to (active/sham/no opinion), plus certainty rating (1-5).
Immediately after biopsy sampling, before unblinding
Operator Satisfaction
Tijdsspanne: Immediately after procedure
Single-item Likert scale (1-5, where 1 = very dissatisfied and 5 = very satisfied with procedural conditions), recorded by the operating urologist immediately after the procedure, assessing overall satisfaction with procedural conditions during the biopsy.
Immediately after procedure
Patient Satisfaction
Tijdsspanne: Immediately after procedure
Single-item Likert scale (1-5, where 1 = very dissatisfied and 5 = very satisfied), recorded immediately after procedure by independent outcome assessor.
Immediately after procedure
Amsterdam Preoperative Anxiety and Information Scale
Tijdsspanne: Administered before the procedure.
Amsterdam Preoperative Anxiety and Information Scale (APAIS; 6 items; Moerman et al., Anesth Analg 1996;82: 445-451; Polish forward-backward translation). Administered before the procedure. Association with primary outcome assessed by Spearman correlation as covariate.
Administered before the procedure.
NRS-Anxiety
Tijdsspanne: Administered before the procedure and immediately after biopsy sampling to assess pre-to-post procedural anxiety change.
NRS-Anxiety (0-10; single item: "How anxious are you right now?"). Administered before the procedure and immediately after biopsy sampling to assess pre-to-post procedural anxiety change. Pre-to-post delta reported as exploratory outcome.
Administered before the procedure and immediately after biopsy sampling to assess pre-to-post procedural anxiety change.
TENS Amplitude vs Pain Reduction
Tijdsspanne: Intraoperative (active group only)
Actual TENS amplitude used (mA) recorded for each participant in the active group. Spearman correlation between amplitude and NRS reduction during PNB.
Intraoperative (active group only)
Pain Catastrophizing Scale (PCS-13)
Tijdsspanne: Before the procedure
Pain Catastrophizing Scale (Sullivan et al., Psychol Assess 1995;7:524-532). 13-item self-report questionnaire, score 0-52. Three subscales: rumination, magnification, helplessness. Polish version available. Administered before the procedure as covariate for primary outcome analysis.
Before the procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medical University of Gdansk

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

3 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

11 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TENS2-TPB-RCT-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data underlying the results reported in the primary publication will be made publicly available at the Open Science Framework (OSF) at the time of publication.

IPD-tijdsbestek voor delen

Beginning at time of publication, no end date.

IPD-toegangscriteria voor delen

Publicly available without restriction via Open Science Framework (OSF).

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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