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

5 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Polonia
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polonia, 80-214
        • Department of Urology, Medical University of Gdansk
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Comparatore fittizio: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
NRS Pain Score During Periprostatic Nerve Block
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
NRS Pain Score During Ultrasound Probe Insertion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medical University of Gdansk

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

3 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TENS2-TPB-RCT-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Beginning at time of publication, no end date.

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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