[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585989":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":50,"collaborators":24,"id":52,"slug":24,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":78,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Voiding Dysfunction","EXPERIMENTAL","Patients with voiding dysfunction only and no pelvic pain symptoms will use the home pelvic floor trainer daily for 2 months.",[13],"Device: Home Pelvic Floor Trainer",{"label":15,"type":10,"description":16,"interventionNames":17},"Pelvic pain","Patients with pelvic pain with or without voiding dysfunction symptoms will use the home pelvic floor trainer daily for 2 months.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Home Pelvic Floor Trainer","The intervention utilizes a perineometer device with biofeedback features.\n\nThis device employs external electrodes to measure pelvic floor muscle strength. It then provides real-time feedback through a smartphone application during exercise sessions. The application uses gamification to engage users and track progress. Patients can choose between two games: a bird game or a space-themed game. In the bird game, patients activate their pelvic floor muscles to make the bird fly upward. In the space game, pelvic floor contractions fire a laser or activate a shield. A visual bar displays the strength of pelvic floor contractions. Games are designed to be played for 5 minutes daily, 7 days a week, with increasing difficulty as the user progresses through levels.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Kelly Harris, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","(720)777-3926","kelly.harris2@childrenscolorado.org",[35],{"facility":36,"status":24,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of Colorado Anschutz","Aurora","Colorado","80011","United States",{"type":42,"coordinates":43},"Point",[44,45],-104.83192,39.72943,{"lat":45,"lon":44},[48],{"name":27,"role":31,"phone":49,"phoneExt":24,"email":33},"720-777-3926",{"type":51,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100585989",false,"NCT06909539","HOme PElvic Floor Improvement Trainer Trial","Using a Perineometer Device With Gamification to Improve Symptom Outcomes in Pediatric Pelvic Floor Dysfunction","HoPE FIT","Inclusion Criteria:\n\n* Dysfunctional voiding symptoms without chronic pelvic pain.\n* Chronic pelvic pain with or without dysfunctional voiding symptoms.\n* Daytime enuresis, nocturnal enuresis, frequency, urgency, dysuria\n* 8 years - 18 years, no one under 8 and no one over 18.\n\nExclusion Criteria:\n\n\\- Has seen a physical therapist for traditional physical therapy of the pelvic floor due to urinary symptoms or chronic pelvic pain within the last 12 months.\n\nNote: This would include patients who begin physical therapy for their pelvic floor outside of the study while enrolled in the study.\n\n-All patients with the following conditions: severe developmental delay such as CP or wheelchair bound, cannot eat by mouth, mechanical ventilation dependence, etc.\n\n* Nonverbal or unable to effectively communicate needs and preferences.\n* Within the voiding dysfunction group, a diagnosis of a congenital GU anomaly (bladder exstrophy, cloacal anomaly, spina bifida, etc.)\n* No initial medication usage will be excluded; however, if the patient begins a new medication or treatment regimen during the study, the patient will be excluded.","ALL","8 Years","18 Years",{"count":63,"type":64},150,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study will gauge the efficacy of a home biofeedback treatment device for pelvic floor dysfunction\u002Fvoiding dysfunction and pelvic pain. Investigators will test the utility of this device as a treatment alternative and\u002For temporary treatment for a patient's symptoms prior to or perhaps in lieu of their physical therapy appointment.",[70,71,9],"Pelvic Pain","Pelvic Floor Dysfunction",[73,74,75,76,77],"voiding dysfunction","pelvic floor dysfunction","pelvic pain","perineometer","gamification","NOT_YET_RECRUITING","2025-04-21",{"date":81,"type":82},"2025-04-24","ACTUAL",{"date":84,"type":64},"2025-06-01",{"date":86,"type":64},"2027-01-01",{"name":5,"class":6},1]