[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647468":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":26,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"Başakşehir Çam & Sakura City Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active TENS","EXPERIMENTAL","TENS pads are applied bilaterally to the pretibial region and the device is operated in active mode during the intravesical onabotulinumtoxinA injection. The standard intravesical BTX-A injection is performed according to routine clinical protocol.",[13],"Device: Active Pretibial TENS",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo TENS (Sham)","PLACEBO_COMPARATOR","TENS pads are applied to the same pretibial anatomical region but the device is not activated (sham). The standard intravesical BTX-A injection is performed according to routine clinical protocol, identical to the active group.",[19],"Device: Sham Pretibial TENS",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active Pretibial TENS","Transcutaneous electrical nerve stimulation delivered through pads placed bilaterally on the pretibial region, with the device turned on (active stimulation) during the intravesical onabotulinumtoxinA injection.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Pretibial TENS","Transcutaneous electrical nerve stimulation pads placed bilaterally on the pretibial region in an identical manner, but with the device not activated (no electrical stimulation delivered), during the intravesical onabotulinumtoxinA injection.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Veysel Sezgin","CONTACT","+905513895655","veyselsezgin1@gmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","SEZGIN","MD VEYSEL SEZGİN","100647468","pretibial-tens-for-pain-and-anxiety-during-intravesical-onabotulinumtoxina-injection-100647468",false,"NCT07707791","Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection","The Effect of Pretibial Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection: A Double-Blind, Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Diagnosis of overactive bladder (OAB) with an indication for intravesical onabotulinumtoxinA (BTX-A) treatment\n* No previous history of TENS application\n* Age 18 years or older\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Presence of a cardiac pacemaker or any implanted neuromodulator device\n* Impaired skin integrity in the pretibial region or peripheral neuropathy\n* Pregnancy\n* Coagulopathy that contraindicates the procedure, or active urinary tract infection","FEMALE","18 Years",{"count":51,"type":52},68,"ESTIMATED","INTERVENTIONAL",[55],"NA","Overactive bladder is a common condition that causes a frequent, urgent need to urinate and can significantly reduce quality of life. When other treatments do not work well enough, doctors can inject a medication called onabotulinumtoxinA (a form of botulinum toxin) into the bladder wall. This procedure is often done in the office and is effective, but it can cause pain and anxiety during the injection.\n\nTranscutaneous electrical nerve stimulation (TENS) is a non-invasive, drug-free method that uses mild electrical pulses delivered through pads placed on the skin. It is thought to reduce the sensation of pain and is already used to help with discomfort during some office procedures.\n\nThe purpose of this study is to find out whether applying TENS to the front of the lower legs (the pretibial area) reduces pain and anxiety in patients undergoing an intravesical onabotulinumtoxinA injection. Participants will be randomly assigned to one of two groups. In one group, the TENS device will be turned on (active). In the other group, the pads will be placed in the same location but the device will not be turned on (placebo). Neither the patient nor the doctor performing the assessment will know which group the patient is in.\n\nPain will be measured during the procedure using a visual analog scale. Anxiety will be measured before the procedure using a standard questionnaire, and patient satisfaction will be measured afterward. The study aims to enroll 68 participants in total.",[58,59,60,61],"Overactive Bladder (OAB)","Botulinum Toxin Injection","Procedural Pain Relief","Anxiety",[63,64,65,66],"Transcutaneous Electrical Nerve Stimulation","Intravesical Injection","Overactive Bladder","Procedural Pain","NOT_YET_RECRUITING","2026-07-13",{"date":70,"type":71},"2026-07-16","ACTUAL",{"date":73,"type":52},"2026-07-20",{"date":75,"type":52},"2027-03-10",{"name":5,"class":6}]