[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487487":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":46,"responsibleParty":79,"collaborators":50,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":50,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":50,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":50,"overallStatus":48,"whyStopped":50,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PelviSense-assisted pelvic floor muscle training group","EXPERIMENTAL","Women allocated to the PelviSense-assisted pelvic floor muscle training (PFMT) group will perform PFMT to contract their urethras while the wearable sensors are positioned close to the vagina (to measure pubococcygeus muscle activation). Exercises will be performed in antigravity (supine or side-lying) positions and will progress to against-gravity positions (sitting\u002F standing).",[13],"Device: PelviSense-assisted pelvic floor muscle training group",{"label":15,"type":16,"description":17,"interventionNames":18},"Pelvic floor muscle training (PFMT) alone group","ACTIVE_COMPARATOR","Pelvic floor muscle training (PFMT) alone group: Women allocated to the PFMT alone group will perform unassisted PFMT. Exercise parameters, technique, and progression will be similar to those for the PelviSense-assisted PFMT group, but exercises will be performed without the PelviSense.",[19],"Other: Active comparator",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The PelviSense consists of a high-precision, oval-shaped, wearable EMG sensor that displays electrical activity measured in PFMs on the user's mobile device. The reusable, wearable EMG sensor is non-invasive and can be attached to the user's perineal region. The mobile app provides real-time muscular feedback, displayed as EMG waveforms in microvolts. The mobile app can store data for up to 7 days, allowing participants to monitor their progress over the last 7 days in a graphical format.",[9],[26],"Non-invasive novel biofeedback",{"type":6,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"Active comparator",[15],[15],[32],{"name":33,"affiliation":5,"role":34},"PRIYA KANNAN, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","3400","3277","priya.kannan@polyu.edu.hk",{"name":42,"role":37,"phone":43,"phoneExt":44,"email":45},"Brigitte Kim Yook Fung, MSc","9836","4398","fungky3@ha.org.hk",[47,65],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":49,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Hong Kong",null,"999077","HK",{"type":54,"coordinates":55},"Point",[56,57],114.17469,22.27832,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":63,"email":64},"Cherrie Mok","2766","6378","cherrie.mok@polyu.edu.hk",{"facility":66,"status":48,"city":67,"state":50,"zip":50,"country":49,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Kwong Wah Hospital","Kowloon",{"type":54,"coordinates":69},[70,71],114.18333,22.31667,{"lat":71,"lon":70},[74,77],{"name":75,"role":37,"phone":76,"phoneExt":50,"email":45},"Brigitte Fung, MScPT","98364398",{"name":78,"role":37,"phone":50,"phoneExt":50,"email":50},"Brigitte Kim Yook Fung",{"type":34,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Dr. Priya Kannan","Assistant Professor","100487487","effectiveness-and-cost-effectiveness-of-pelvisense-a-novel-biofeedback-device-for-stress-urinary-incontinence-in-women-100487487",false,"NCT05627726","Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women","Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device With Wearable Sensors for Stress Urinary Incontinence in Women: a Randomised Controlled Trial Alongside Economic Evaluation","Inclusion Criteria:\n\n* non-pregnant women with stress urinary incontinence (SUI),\n* aged 35 to 65 years,\n* women who experience mild to moderate SUI, as indicated by a pad weight gain of 1-50 g during the 1-hour pad test with stress test,\n* women with a score ≥24 on the Mini-Mental State Examination.\n\nExclusion Criteria:\n\n* women \\\u003C6 months postpartum,\n* women with severe pelvic organ prolapse,\n* women with complicated SUI due to pelvic region radiation,\n* women with a body mass index (BMI) ≥30,\n* women with severe psychological problems impairing study participation,\n* women with mixed urinary incontinence (MUI) or urge urinary incontinence (UUI)","FEMALE","35 Years","65 Years",{"count":93,"type":94},142,"ESTIMATED","INTERVENTIONAL",[97],"NA","Aims: (1) Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for improving SUI symptom severity in women; (2) Compare the cost-effectiveness of the PelviSense device against PFMT alone for treating SUI in women; (3) Explore the views of women regarding the use of the PelviSense device as an adjunct to PFMT and the impacts of the PelviSense device on their lives and well-being.\n\nDesign and subjects: A sequential, embedded, experimental mixed-methods design, including a randomised controlled trial (RCT) and semi-structured focus groups, will be conducted alongside an economic evaluation. The proposed study will include 142 women with SUI or stress-predominant mixed urinary incontinence.\n\nInterventions: Women will be randomly allocated to one of two groups (PelviSense or PFMT alone \\[control\\]). The PelviSense group will perform PFMT with assistance from the PelviSense device, and the control group will perform PFMT without biofeedback (i.e., PFMT alone).\n\nOutcome measures: International Consultation on Incontinence Questionnaire-Short Form, one-hour pad test, Modified Oxford Scale, EQ-5D-5L, and electronic cost diary.\n\nData analysis and expected results: Statistical analysis will be conducted using analysis of covariance. The PelviSense group is expected to report significant improvements in primary and secondary outcomes compared with the PFMT alone group. The PelviSense group will yield cost savings and result in lower health care utility compared with the PFMT alone group.",[100],"Stress Urinary Incontinence","2025-03-12",{"date":103,"type":104},"2025-03-17","ACTUAL",{"date":106,"type":104},"2024-04-01",{"date":108,"type":94},"2026-10-26",{"name":5,"class":6},2]