[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577357":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":40,"responsibleParty":226,"collaborators":228,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":234,"sex":240,"minAge":241,"maxAge":25,"enrollmentInfo":242,"targetDuration":25,"studyType":245,"phases":246,"briefSummary":248,"conditions":249,"keywords":255,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},{"fullName":5,"class":6},"Medstar Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention - RiSolve PDTx App","EXPERIMENTAL","Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.",[13],"Device: RiSolve App",{"label":15,"type":16,"description":17,"interventionNames":18},"Control - Standard Therapy","ACTIVE_COMPARATOR","Participants randomized to the control will receive a brief explanation of behavioral therapy with details provided in the form educational handouts including the American Urogynecologic Society (AUGS) \"Overactive Bladder\" and \"Pelvic Floor Muscles and Bladder Training\" Patient Fact Sheets.",[19],"Behavioral: AUGS Patient Handouts",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","RiSolve App",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BEHAVIORAL","AUGS Patient Handouts","AUGS \"Overactive Bladder\" and \"Pelvic Floor Muscles and Bladder Training\" Patient Fact Sheets will be provided and reviewed.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Patricia Moriarty","CONTACT","202-877-0486","approvetrial@medstar.net",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":25},"Alexis Dieter, MD","202-877-6526",[41,72,89,113,130,141,158,175,192,209],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35249","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-86.80249,33.52066,{"lat":53,"lon":52},[56,60,63,66,68,70],{"name":57,"role":34,"phone":58,"phoneExt":25,"email":59},"Elizabeth Kilpatrick","205-801-5830","ekilpatrick@uabmc.edu",{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Gabriela Halder, MD","PRINCIPAL_INVESTIGATOR",{"name":64,"role":65,"phone":25,"phoneExt":25,"email":25},"Holly Richter, MD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":25,"phoneExt":25,"email":25},"Gena Dunivan, MD",{"name":69,"role":65,"phone":25,"phoneExt":25,"email":25},"David Ellington, MD",{"name":71,"role":65,"phone":25,"phoneExt":25,"email":25},"Thomas Powell, MD",{"facility":73,"status":43,"city":74,"state":75,"zip":76,"country":47,"countryCode":48,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Stanford University","Palo Alto","California","94304",{"type":50,"coordinates":78},[79,80],-122.14302,37.44188,{"lat":80,"lon":79},[83,87],{"name":84,"role":34,"phone":85,"phoneExt":25,"email":86},"Shyairra Dodd","650-497-5175","gynresearch@stanford.edu",{"name":88,"role":62,"phone":25,"phoneExt":25,"email":25},"Eric Sokol, MD",{"facility":90,"status":43,"city":91,"state":92,"zip":93,"country":47,"countryCode":48,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"MedStar Health","Washington D.C.","District of Columbia","20010",{"type":50,"coordinates":95},[96,97],-77.03637,38.89511,{"lat":97,"lon":96},[100,104,106,108,110,112],{"name":101,"role":34,"phone":102,"phoneExt":25,"email":103},"Kendra Green","(202) 997-4536","kendra.s.green@medstar.net",{"name":105,"role":62,"phone":25,"phoneExt":25,"email":25},"Robert Gutman, MD",{"name":107,"role":65,"phone":25,"phoneExt":25,"email":25},"Cheryl Iglesia, MD",{"name":109,"role":65,"phone":25,"phoneExt":25,"email":25},"Lee Ann Richter, MD",{"name":111,"role":65,"phone":25,"phoneExt":25,"email":25},"Andrew Sokol, MD",{"name":38,"role":65,"phone":25,"phoneExt":25,"email":25},{"facility":114,"status":43,"city":115,"state":116,"zip":117,"country":47,"countryCode":48,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"University of Chicago","Chicago","Illinois","60637",{"type":50,"coordinates":119},[120,121],-87.65005,41.85003,{"lat":121,"lon":120},[124,128],{"name":125,"role":34,"phone":126,"phoneExt":25,"email":127},"Samsel","773-795-8777","tara.samsel@bsd.uchicago.edu",{"name":129,"role":62,"phone":25,"phoneExt":25,"email":25},"Margaret Mueller, MD",{"facility":131,"status":132,"city":133,"state":134,"zip":135,"country":47,"countryCode":48,"cosmosGeoPoint":136,"geoPoint":140,"contacts":25},"Curavit","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02116",{"type":50,"coordinates":137},[138,139],-71.05977,42.35843,{"lat":139,"lon":138},{"facility":142,"status":43,"city":143,"state":144,"zip":145,"country":47,"countryCode":48,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Atrium Health Wake Forest Baptist","Winston-Salem","North Carolina","27103",{"type":50,"coordinates":147},[148,149],-80.24422,36.09986,{"lat":149,"lon":148},[152,156],{"name":153,"role":34,"phone":154,"phoneExt":25,"email":155},"Vyas","3336-713-4098","svyas@wakehealth.edu",{"name":157,"role":62,"phone":25,"phoneExt":25,"email":25},"Candace Parker-Autry, MD",{"facility":159,"status":43,"city":160,"state":161,"zip":162,"country":47,"countryCode":48,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Allegheny Health","Pittsburgh","Pennsylvania","15224",{"type":50,"coordinates":164},[165,166],-79.99589,40.44062,{"lat":166,"lon":165},[169,173],{"name":170,"role":34,"phone":171,"phoneExt":25,"email":172},"Winkelman","412-578-4368","Monica.Winkelman@ahn.org",{"name":174,"role":62,"phone":25,"phoneExt":25,"email":25},"Erin Lavelle, MD",{"facility":176,"status":43,"city":177,"state":178,"zip":179,"country":47,"countryCode":48,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Medical University of South Carolina Health","Charleston","South Carolina","29425",{"type":50,"coordinates":181},[182,183],-79.93275,32.77632,{"lat":183,"lon":182},[186,190],{"name":187,"role":34,"phone":188,"phoneExt":25,"email":189},"Payne","843-792-7525","paynej@musc.edu",{"name":191,"role":62,"phone":25,"phoneExt":25,"email":25},"Amy Askew, MD",{"facility":193,"status":43,"city":194,"state":195,"zip":196,"country":47,"countryCode":48,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":50,"coordinates":198},[199,200],-96.80667,32.78306,{"lat":200,"lon":199},[203,207],{"name":204,"role":34,"phone":205,"phoneExt":25,"email":206},"Agnes Burris, RN","214-645-3833","agnes.burris@utsouthwestern.edu",{"name":208,"role":62,"phone":25,"phoneExt":25,"email":25},"Maria E. Florian-Rodriguez, MD, FACOG",{"facility":210,"status":43,"city":211,"state":212,"zip":213,"country":47,"countryCode":48,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"University of Wisconsin","Madison","Wisconsin","53715",{"type":50,"coordinates":215},[216,217],-89.40123,43.07305,{"lat":217,"lon":216},[220,224],{"name":221,"role":34,"phone":222,"phoneExt":25,"email":223},"Rosenbaum","608-263-6240","lrosenbaum2@wisc.edu",{"name":225,"role":62,"phone":25,"phoneExt":25,"email":25},"Jon Pennycuff, MD",{"type":227,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[229],{"name":230,"class":231},"Foundation for Female Health Awareness (FFHA)","UNKNOWN","100577357","approve-trial-evaluating-a-prescription-digital-therapeutic-for-treatment-of-oab-in-women-100577357",false,"NCT06797245","APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women","The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women","APPROVE","Inclusion Criteria:\n\n* Women ≥ 22 years old\n* Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)\n* English-speaking\n* Willing to forego other treatment outside of medications for the 8-week trial period\n* Use of at least one mobile App\n\nExclusion Criteria:\n\n* Stress-predominant mixed urinary incontinence (defined as QUID stress score \\> QUID urge score)\n* Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a\n* Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a\n* Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks\n* Currently using intermittent or indwelling catheter\n* History of bladder\u002Furethral, colon\u002Fanal, or cervical cancer\n* Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection\n* Currently taking antibiotics\u002Fdrugs for urinary tract infection\\^\n* Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period\n* Planning surgery for pelvic organ prolapse within 12 months of randomization\n* Pelvic surgery within the past 6 months\n* Planning to undergo pessary fitting °\n\n  * Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting\n\nhttps:\u002F\u002Fresearchdata.medstar.net\u002Fredcap\u002Fsurveys\u002F?s=MM7WN7EXACX4PNXJ","FEMALE","22 Years",{"count":243,"type":244},596,"ESTIMATED","INTERVENTIONAL",[247],"NA","The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).",[250,251,252,253,254],"Overactive Bladder (OAB)","Urinary Urgency","Urinary Urge Incontinence (UUI)","Nocturia","Urinary Frequency",[250],"2025-10-24",{"date":258,"type":259},"2025-10-27","ACTUAL",{"date":261,"type":259},"2025-03-17",{"date":263,"type":244},"2028-07",{"name":5,"class":6},10]