[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547683":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":29,"locations":44,"responsibleParty":168,"collaborators":170,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":188,"sex":193,"minAge":194,"maxAge":29,"enrollmentInfo":195,"targetDuration":29,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"NICHD Pelvic Floor Disorders Network","NETWORK",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventionist-guided training","ACTIVE_COMPARATOR","Interventionist-guided training at baseline (i.e., approximately 8 weeks postpartum), followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session approximately 4 weeks later, and then continued HEP. Two exercise sets per day are encouraged between baseline and 6 months postpartum (i.e., time of the primary outcome), followed by at least 3 times-per-week exercise sets until 12 months postpartum. Home exercises will be encouraged using a PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.",[13],"Other: Interventionist-guided training",{"label":15,"type":10,"description":16,"interventionNames":17},"Home pelvic floor exercises guided by the leva® device","Home pelvic floor exercises guided by the leva® device and its accompanying app\u002Fsoftware for gradually increasing strength and duration of pelvic floor contractions. The PFDN research smartphone app will have weekly queries of whether exercises were completed.",[18],"Device: Home pelvic floor exercises guided by the leva® device",{"label":20,"type":21,"description":22,"interventionNames":23},"Education","OTHER","Education will be provided on pelvic floor muscle function and continence mechanisms. No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises.",[24],"Other: Education",[26,30,34],{"type":21,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Interventionist-guided training at baseline (i.e., approximately 6 weeks postpartum), followed by a Home Exercise Prescription (HEP), a second interventionist-guided training session approximately 4 weeks later, and then continued HEP. Two exercise sets per day are encouraged between baseline and 6 months postpartum (i.e., time of the primary outcome), followed by at least 3 times-per-week exercise sets until 12 months postpartum. Home exercises will be encouraged using a PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.",[9],null,{"type":31,"name":15,"description":32,"armGroupLabels":33,"otherNames":29},"DEVICE","Home pelvic floor exercises guided by the leva® device and its accompanying app\u002Fsoftware for gradually increasing strength and duration of pelvic floor contractions. Between baseline and 6 months postpartum, twice-daily exercise sets will be encouraged, followed by at least 3 times-per-week exercises from 6 to 12 months postpartum. As in Arm 1, the PFDN research smartphone app, resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed.",[15],{"type":21,"name":20,"description":22,"armGroupLabels":35,"otherNames":29},[20],[37,41],{"name":38,"affiliation":39,"role":40},"David Rahn, MD","UTSW","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":40},"Marie Gantz, PhD","RTI International",[45,71,84,101,118,135,152],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Kaiser Permanente -- San Diego","RECRUITING","San Diego","California","92110","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-117.16472,32.71571,{"lat":57,"lon":56},[60,65,69],{"name":61,"role":62,"phone":63,"phoneExt":29,"email":64},"Gisselle Zazueta-Damian","CONTACT","619-821-5717","gisselle.zazueta-damian@kp.org",{"name":66,"role":62,"phone":67,"phoneExt":29,"email":68},"Linda Mackinnon","619-821-6009","linda.m.mackinnon@kp.org",{"name":70,"role":40,"phone":29,"phoneExt":29,"email":29},"Shawn A Menefee, MD",{"facility":72,"status":47,"city":48,"state":49,"zip":73,"country":51,"countryCode":52,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"University of California - San Diego","92121",{"type":54,"coordinates":75},[56,57],{"lat":57,"lon":56},[78,82],{"name":79,"role":62,"phone":80,"phoneExt":29,"email":81},"Kyle Herrala","858-657-6827","UrogynRSCH@ucsd.edu",{"name":83,"role":40,"phone":29,"phoneExt":29,"email":29},"Emily Lukacz, MD",{"facility":85,"status":47,"city":86,"state":87,"zip":88,"country":51,"countryCode":52,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University of Chicago","Chicago","Illinois","60637",{"type":54,"coordinates":90},[91,92],-87.65005,41.85003,{"lat":92,"lon":91},[95,99],{"name":96,"role":62,"phone":97,"phoneExt":29,"email":98},"Jinxuan (Rowena) Shi","872-724-0774","jinxuan.shi@bsd.uchicago.edu",{"name":100,"role":40,"phone":29,"phoneExt":29,"email":29},"Kimberly Kenton, MD",{"facility":102,"status":47,"city":103,"state":104,"zip":105,"country":51,"countryCode":52,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery","Durham","North Carolina","27707",{"type":54,"coordinates":107},[108,109],-78.89862,35.99403,{"lat":109,"lon":108},[112,116],{"name":113,"role":62,"phone":114,"phoneExt":29,"email":115},"Stephanie Yu","(919) 401-1016","stephanie.yu@duke.edu",{"name":117,"role":40,"phone":29,"phoneExt":29,"email":29},"Nazema Siddiqui, MD",{"facility":119,"status":47,"city":120,"state":121,"zip":122,"country":51,"countryCode":52,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":54,"coordinates":124},[125,126],-75.16362,39.95238,{"lat":126,"lon":125},[129,133],{"name":130,"role":62,"phone":131,"phoneExt":29,"email":132},"Zandra Kennedy","(215) 615-6569","zandra.kennedy@pennmedicine.upenn.edu",{"name":134,"role":40,"phone":29,"phoneExt":29,"email":29},"Heidi Harvie, MD",{"facility":136,"status":47,"city":137,"state":138,"zip":139,"country":51,"countryCode":52,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Brown\u002F Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery","Providence","Rhode Island","02903",{"type":54,"coordinates":141},[142,143],-71.41283,41.82399,{"lat":143,"lon":142},[146,150],{"name":147,"role":62,"phone":148,"phoneExt":29,"email":149},"Julia Shinnick, MD","(401) 453-7560","jshinnick@wihri.org",{"name":151,"role":40,"phone":29,"phoneExt":29,"email":29},"Vivian Sung, MD",{"facility":153,"status":47,"city":154,"state":155,"zip":156,"country":51,"countryCode":52,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":54,"coordinates":158},[159,160],-96.80667,32.78306,{"lat":160,"lon":159},[163,167],{"name":164,"role":62,"phone":165,"phoneExt":29,"email":166},"Agnes Burris","(214) 645-3833","Agnes.Burris@UTSouthwestern.edu",{"name":38,"role":40,"phone":29,"phoneExt":29,"email":29},{"type":169,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[171,174,176,178,180,181,182,183,185],{"name":172,"class":173},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":175,"class":21},"Duke University",{"name":177,"class":21},"Kaiser Permanente",{"name":179,"class":21},"University of California, San Diego",{"name":85,"class":21},{"name":119,"class":21},{"name":153,"class":21},{"name":184,"class":21},"Women and Infants Hospital of Rhode Island",{"name":43,"class":21},"100547683","training-for-urinary-leakage-improvement-after-pregnancy-100547683",false,"NCT06411158","Training for Urinary Leakage Improvement After Pregnancy","TULIP","Inclusion Criteria:\n\n1. ≥18yo primiparous patient s\u002Fp singleton vaginal delivery (\\>32 weeks), approximately 6wk postpartum\n2. At increased risk of sustained pelvic floor disorders, as defined by\n\n   1. neonate ≥3.5kg, and\u002For\n   2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and\u002For\n   3. ≥2nd-degree perineal laceration\n3. Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.\n\nExclusion Criteria:\n\n1. Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up\n2. Stillbirth or significant maternal or neonatal illness\n3. Non-English or non-Spanish speaking\n4. Perineal wound breakdown or cloaca observed on exam\n5. Severe pain with assessments of PFM integrity and\u002For strength\u002Ffunction\n6. Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor\n7. Unwilling or unable to upload and use external smartphone app(s)","FEMALE","18 Years",{"count":196,"type":197},216,"ESTIMATED","INTERVENTIONAL",[200],"NA","This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged\u002Fsustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment.\n\nTULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®).\n\nThe primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.",[203,204],"Urinary Incontinence","Delivery Complication",[203,206,207,208,209],"Pelvic Floor Disorders","Physical Therapy","Biofeedback","Anal Incontinence","2025-12-29",{"date":212,"type":213},"2025-12-31","ACTUAL",{"date":215,"type":213},"2024-11-12",{"date":217,"type":197},"2027-11-12",{"name":5,"class":6},7]