[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544518":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":39,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active TENS","EXPERIMENTAL","In the active treatment group, the TENS unit will remain on up to 30 minutes (10 minutes pre-procedure, during the procedure and during the questionnaires).",[13],"Procedure: TENS",{"label":15,"type":16,"description":17,"interventionNames":18},"Control TENS","SHAM_COMPARATOR","The sham stimulation group will undergo the same procedure; however, the TENS stimulation current will be reduced to a minimal detectable level and turned off after 20 seconds.",[19],"Procedure: Control TENS",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","TENS","This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (the procedure typically takes 5-15 minutes). The TENS units have pre-program settings, improving convenience, reproducibility, and reliability. Study staff will be instructed to perform TENS using an \"Acupuncture\" mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.",[9],null,{"type":22,"name":15,"description":24,"armGroupLabels":28,"otherNames":26},[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Jared M Floch, DO, MS","CONTACT","585-895-9301","jared_floch@urmc.rochester.edu",{"name":36,"role":32,"phone":37,"phoneExt":26,"email":38},"Diego Hernandez-Aranda, MD","585-487-3400","diego_hernandezaranda@urmc.rochester.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Pelvic Health and Continence Specialties","RECRUITING","Rochester","New York","14623","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-77.61556,43.15478,{"lat":52,"lon":51},[55,56,58],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},{"name":36,"role":32,"phone":57,"phoneExt":26,"email":38},"(585) 487-3400",{"name":31,"role":59,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jared Matthew Floch","Fellow","100544518","tens-analgesia-during-outpatient-urethral-bulking-for-stress-urinary-incontinence-100544518",false,"NCT06369922","TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.","Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.","TENSUB","Inclusion Criteria:\n\n* • Women, Age ≥18 years\n\n  * Diagnosis of SUI\n  * Scheduled to undergo transurethral bulking in the office\n  * Able to read\u002Fwrite English\n\nExclusion Criteria:\n\n* • Cutaneous damage such as ulcers or broken skin on target treatment area\n\n  * Currently implanted cardiac pacemaker or defibrillator\n  * Pre-procedural use of opioids for pain management, less than 8 hours from last dose\n  * Participants with altered sensation below the umbilicus","FEMALE","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.",[81,82,83,84,85],"Stress Incontinence Female","Urinary Incontinence","Urinary Incontinence,Stress","Pain","Pain Acute",[23,87,88],"pain","Transcutaneous Electrical Nerve Stimulation Analgesia","2026-05-11",{"date":91,"type":92},"2026-05-13","ACTUAL",{"date":94,"type":92},"2024-07-01",{"date":96,"type":75},"2027-06-01",{"name":5,"class":6},1]