[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563554":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":22,"centralContacts":29,"locations":22,"responsibleParty":35,"collaborators":22,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":22,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":66,"whyStopped":22,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":22},{"fullName":5,"class":6},"Louisiana State University Health Sciences Center Shreveport","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"TTNS - two times per week","EXPERIMENTAL","Participants will receive transcutaneous tibial nerve stimulation for 30 minutes with a frequency of 12 Hz, pulse width of 300 microseconds, and to an intensity of the participant's tolerance under the motor threshold. This group will receive treatment two times per week.",[13],"Device: Transcutaneous tibial nerve stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"TTNS - four times per week","Participants will receive transcutaneous tibial nerve stimulation for 30 minutes with a frequency of 12 Hz, pulse width of 300 microseconds, and to an intensity of the participant's tolerance under the motor threshold. This group will receive treatment four times per week.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"No treatment group","NO_INTERVENTION","Treatment will be deferred after 12 weeks.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"DEVICE","Transcutaneous tibial nerve stimulation","Two electrodes will be place over the tibial nerve over the medial ankle. The electrical stimulation will be turned up to patient tolerance at a sensory level only.",[15,9],[30],{"name":31,"role":32,"phone":33,"phoneExt":22,"email":34},"Amanda T Mahoney, DPT, PT","CONTACT","318-813-2970","amanda.mahoney@lsuhs.edu",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Amanda Mahoney","Clinical Assistant Professor - Physical Therapy","100563554","transcutaneous-tibial-nerve-stimulation-for-overactive-bladder-syndrome-and-associated-gait-changes-in-post-menopausal-women-100563554",false,"NCT06617676","Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women","TTNS","Inclusion Criteria: Inclusion criteria include females over 60 years of age who score an 8 or greater on the OAB-V8 with no exclusion criteria.\n\n\\-\n\nExclusion Criteria: those who experience stress UI only, have a pacemaker, neurologic deficit (e.g. Parkinson\\'s disease, multiple sclerosis, spinal cord injury), current urinary tract infection, known active cancer, or current OAB medication use (Tolterdine, etc.) with consideration of a washout period, and inability to walk 30 meters.\n\n\\-","FEMALE","60 Years","85 Years",{"count":50,"type":51},60,"ESTIMATED","INTERVENTIONAL",[54],"NA","The goal of this clinical trial is to learn if surface tibial electrical stimulation (mild electrical signals on the inside of the ankle) helps women 60 years or older with urine leakage that happens on the way to the bathroom or at night time. The main questions it aims to answer are: 1). How many treatments per week over a 12-week period improve a person\\'s bladder symptoms?; 2). Is a person more confident that they will not fall and \u002F or leak urine on the way to the bathroom after the treatment with the electrical stimulation treatments; 3). Does the way a person walks when they need to go to the bathroom change after they have had the electrical stimulation? They will visit the clinic 3 times to complete several questionnaires and walk with a full bladder and empty bladder. On the first visit, the participant will be taught how to use the electrical stimulation device. Participants will either receive the treatment 2 or 4 times per week for 12 weeks or no treatment with the option to receive treatment following the 12 weeks. Participants will be given a bladder diary to complete at the start of treatment, at 6 weeks, then at 12 weeks and will be instructed in completion. They will drink water until they have a strong urge to urinate, then will walk along an electronic pathway and will go empty their bladder. After emptying, they will walk back along the electronic pathway again. They will also complete a Timed Up and Go test - stand up from a chair, walk 3 meters, then turn around, walk back, then sit down. At the 6th week follow up and the 12th week follow up, they will complete each questionnaire again and complete the walking tasks again.",[57,58,59],"Overactive Bladder Syndrome","Urinary Incontinence, Urge","Nocturia",[61,62,63,64,65,59],"Overactive bladder syndrome","Transcutaneous sacral nerve stimulation","Falls","Urinary urgency","Urinary frequency","NOT_YET_RECRUITING","2024-09-26",{"date":69,"type":70},"2024-09-27","ACTUAL",{"date":72,"type":51},"2024-10",{"date":74,"type":51},"2026-03",{"name":5,"class":6}]