[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638672":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active TENS","EXPERIMENTAL","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.",[13],"Device: Transcutaneous Electrical Nerve Stimulation (TENS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham TENS","SHAM_COMPARATOR","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.",[19],"Device: Sham Transcutaneous Electrical Nerve Stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Bartłomiej Marczak, MD","CONTACT","+48 790 710 909","bartlomiej.marczak@gumed.edu.pl",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Department of Urology, Medical University of Gdansk","Gdansk","Pomeranian Voivodeship","80-214","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],18.64912,54.35227,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Bartłomiej Marczak","Urologist, Department of Urology","100638672","tens-as-an-adjunct-to-local-anaesthesia-during-transperineal-prostate-biopsy-a-randomized-sham-controlled-trial-100638672",false,"NCT07578324","TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial","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","TENS 2","Inclusion Criteria:\n\n* Male patients aged 40 years or older\n* Indication for prostate biopsy: elevated serum PSA (as per institutional protocol and EAU guidelines) or abnormal digital rectal examination (DRE)\n* Suspicious lesion on multiparametric MRI classified as PI-RADS score 3 or higher (version 2.1)\n* Scheduled for transperineal MRI-ultrasound fusion-guided prostate biopsy under local anaesthesia\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior treatment for prostate cancer (surgical, radiotherapy, hormonal or focal therapy)\n* 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\n* Contraindications to transperineal biopsy: active urinary tract infection; bleeding disorder or ongoing anticoagulation not amendable to bridging; anatomical abnormalities preventing safe prostatic access\n* Known allergy or intolerance to local anaesthetic agents or biopsy-related materials\n* Severe comorbidities or unstable medical condition compromising procedural safety\n* Inability to complete questionnaires\n* Participation in another interventional clinical trial within 30 days prior to enrolment","MALE","40 Years",{"count":68,"type":69},140,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.\n\nTranscutaneous 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.\n\nThis 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.\n\nPain 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.",[75,76,77],"Prostate Cancer (Diagnosis)","Prostate Biopsy","Pain, Procedural",[79,80,81,82,83,84,85,86],"Transcutaneous Electrical Nerve Stimulation","TENS","Transperineal Prostate Biopsy","Local Anaesthesia","Periprostatic Nerve Block","Pain Management","MRI-Ultrasound Fusion Biopsy","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-05-05",{"date":90,"type":91},"2026-05-11","ACTUAL",{"date":93,"type":69},"2026-06",{"date":95,"type":69},"2027-02",{"name":5,"class":6},1]