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

5. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

140

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.
Schein-Komparator: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
NRS Pain Score During Periprostatic Nerve Block
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
NRS Pain Score During Ultrasound Probe Insertion
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Medical University of Gdansk

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

3. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Mai 2026

Zuerst gepostet (Tatsächlich)

11. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TENS2-TPB-RCT-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

Beginning at time of publication, no end date.

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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