[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458713":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":31,"collaborators":20,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":20,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":20,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":20,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Use of Foley Catheter Assistive Device","EXPERIMENTAL","All participants will use Foley Catheter Assistive Device",[13],"Device: Use of the foley catheter assistive device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Use of the foley catheter assistive device","All participants will use the foley catheter assistive device when performing their daily enema",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jill Ketzer","CONTACT","720-777-4960","Jill.Ketzer@childrenscolorado.org",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Andrea Bischoff, MD","720-777-9448","andrea.bischoff@childrenscolorado.org",{"type":32,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100458713","enema-device-for-children-with-spina-bifida-100458713",false,"NCT05253196","Enema Device for Children With Spina Bifida","Inclusion Criteria:\n\n* Poor sphincter tone\n* Perform regular enemas for bowel management (due to fecal incontinence)\n* 2 - 30 years old\n\nExclusion Criteria:\n\n* Non English speakers\n* Prisoners\n* Pregnant women\n* Wards of state\n* Decisionally challenged adults","ALL","2 Years","30 Years",{"count":43,"type":44},20,"ESTIMATED","INTERVENTIONAL",[47],"NA","The International Center for Colorectal and Urogenital Care at Children's Hospital Colorado treats patients who suffer from many different colorectal issues such as anorectal malformation, Hirschsprung disease, and severe constipation. Many of these patients suffer from fecal incontinence. The investigators have developed a week long bowel management program (BMP) that is offered every month to help these kids stay clean of stool in the underwear, by finding the perfect enema recipe to clean the colon for 24 hours. This allows one to perform an enema once every day, clean their colon, and remain free of 'accidents'. Many spina bifida patients also suffer from fecal incontinence and are referred to this BMP. The overall success rate for all patients who suffer from fecal incontinence is 95%, however the success rate for spina bifida patients is only 77%. The reason for this decrease in success is due to the lack of anal sphincter tone in spina bifida patients, which leads to inadvertent leakage and spillage of enema fluid and bowel content during enema administration. The purpose of this study is to create and test an enema administration device that improves upon current methods.",[50,51],"Spina Bifida","Fecal Incontinence","NOT_YET_RECRUITING","2024-10-10",{"date":55,"type":56},"2024-10-15","ACTUAL",{"date":58,"type":44},"2025-06",{"date":60,"type":44},"2027-06",{"name":5,"class":6}]