[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562911":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":46,"overallOfficials":32,"centralContacts":52,"locations":62,"responsibleParty":96,"collaborators":32,"id":98,"slug":32,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":32,"enrollmentInfo":107,"targetDuration":32,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":64,"whyStopped":32,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Feasibility","Feasibility will be assessed using participant reported discomfort with device use, ease of device use, net promotor score, patient satisfaction, and free text feedback on the device.","From enrollment to 6 months postpartum",{"measure":14,"description":15,"timeFrame":12},"Perineal Pain","Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.",[17,20,23,26,29],{"measure":18,"description":19,"timeFrame":12},"Bladder function","Participants will complete validated surveys assessing bladder function at baseline, 3 months postpartum, and 6 months postpartum.",{"measure":21,"description":22,"timeFrame":12},"Bowel Function","Participants will complete validated surveys assessing bowel function at baseline, 3 months postpartum, and 6 months postpartum.",{"measure":24,"description":25,"timeFrame":12},"Pelvic Organ Prolapse","Participants will complete validated surveys assessing pelvic organ prolapse symptoms at baseline, 3 months postpartum, and 6 months postpartum.",{"measure":27,"description":28,"timeFrame":12},"Vaginal pain","Participants will complete validated surveys assessing vaginal pain at baseline, 3 months postpartum, and 6 months postpartum.",{"measure":30,"description":31,"timeFrame":12},"Sexual function","Participants will complete validated surveys assessing sexual function at 3 months postpartum and 6 months postpartum.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"Device Arm","EXPERIMENTAL","Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training",[45],"Device: Digital therapeutic motion-based device",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":32},"DEVICE","Digital therapeutic motion-based device","This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training",[41],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":32,"email":57},"Katie Propst, MD","CONTACT","813-259-0655","katiepropst@usf.edu",{"name":59,"role":55,"phone":60,"phoneExt":32,"email":61},"Maha Al Jumaily, MBBS","813-259-8680","mahaaljumaily@usf.edu",[63,80],{"facility":5,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Tampa","Florida","33606","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-82.45843,27.94752,{"lat":74,"lon":73},[77,78],{"name":59,"role":55,"phone":60,"phoneExt":32,"email":61},{"name":54,"role":79,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"facility":81,"status":64,"city":82,"state":83,"zip":84,"country":68,"countryCode":69,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Ohio State University Wexner Medical Center","Columbus","Ohio","43210",{"type":71,"coordinates":86},[87,88],-82.99879,39.96118,{"lat":88,"lon":87},[91,95],{"name":92,"role":55,"phone":93,"phoneExt":32,"email":94},"Lisa Hickman, MD","614-293-4643","PEARLstudy@osumc.edu",{"name":92,"role":79,"phone":32,"phoneExt":32,"email":32},{"type":97,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100562911",false,"NCT06609317","Postpartum pElvic Assisted Recovery With Leva","Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population","PEARL","Inclusion Criteria:\n\n* Spontaneous vaginal delivery within the last 4-8 weeks\n* Age ≥ 18 years\n* Ambulatory\n* Willing and able to consent to participate.\n* English speaking\n* Owns a smartphone\n\nExclusion Criteria:\n\n* Operative or cesarean delivery\n* Obstetric delivery at less than 20 weeks gestation\n* Third- or fourth-degree perineal laceration\n* Episiotomy\n* Multiples","FEMALE","18 Years",{"count":108,"type":109},25,"ESTIMATED","INTERVENTIONAL",[34],"The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device.\n\nIn addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. Investigators also will assess sexual function at 3 and 6 months postpartum.\n\nParticipants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.",[114],"Postpartum Pelvic Floor Function and Symptoms",[116,117,118,119,120,121],"postpartum pelvic muscle training","postpartum pelvic floor","postpartum pelvic floor physical therapy","postpartum urinary incontinence","postpartum bowel incontinence","postpartum pelvic floor recovery","2025-07-24",{"date":124,"type":125},"2025-07-29","ACTUAL",{"date":127,"type":125},"2025-04-04",{"date":129,"type":109},"2026-02",{"name":5,"class":6},2]