Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:31 PM
Study NCT ID:
NCT07390318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bowel Continence Across the Lifespan in People With Spina Bifida
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016135', 'term': 'Spinal Dysraphism'}, {'id': 'D055496', 'term': 'Neurogenic Bowel'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 943}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel continence', 'timeFrame': 'Before starting enema program, 6 months after starting enema program, 1 year after starting enema program', 'description': 'Measured with a single question on bowel incontinence frequency in the past month, with "continence" strictly defined as answering "never": (Daily, Weekly, Monthly, Never)'}], 'secondaryOutcomes': [{'measure': 'Bowel symptoms and satisfaction', 'timeFrame': 'Before starting enema program, 6 months after starting enema program, 1 year after starting enema program', 'description': 'Measured using the Neurogenic Bowel Dysfunction (NBD) score. Scores range from 0-47, higher scores mean greater severity of bowel dysfunction.'}, {'measure': 'Disease-specific quality of life', 'timeFrame': 'Before starting enema program, 6 months after starting enema program, 1 year after starting enema program', 'description': 'Measured using the Quality of Life Assessment in Spina Bifida (QUALAS) Child, Teenager, and Adult questionnaires. Scores range from 0-100, higher scores mean better quality of life.'}, {'measure': 'Overall quality of life', 'timeFrame': 'Before starting enema program, 6 months after starting enema program, 1 year after starting enema program.', 'description': 'Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health and Pediatric Global Health 7 questionnaires. Raw scores are converted into T-scores, which range from 16.2-67.7 for PROMIS Global Health and 16-67.5 for PROMIS Pediatric Global Health 7. Higher scores mean better quality of life.'}, {'measure': 'Self-management and independence', 'timeFrame': 'Before starting enema program, 6 months after starting enema program, 1 year after starting enema program', 'description': 'Measured using the Adolescent/Young Adult Self-Management and Independence Scale (AMIS) II. Scores range from 36-252, higher scores mean higher level of self-management and independence.'}, {'measure': 'Rate of unplanned healthcare utilization related to bowel issues', 'timeFrame': 'For 1 year after starting enema program', 'description': 'Number of emergency room visits, urgent care or immediate care visits, and urgent outpatient ambulatory visits related to bowel issues.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retrograde enema', 'antegrade enema', 'bowel management program', 'bowel continence program', 'self-management', 'quality of life'], 'conditions': ['Spina Bifida', 'Neurogenic Bowel', 'Bowel Incontinence']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn how different enema programs affect bowel control in children and adults with spina bifida. An enema program involves putting liquid into the large intestine (colon) to help someone poop. The main questions it aims to answer are:\n\n1. How well do different enema programs prevent bowel accidents?\n2. How do these enema programs affect independence, bowel symptoms, and quality of life?\n\nResearchers will compare two types of enema programs to see which works better and is easier for participants to manage.\n\nParticipants starting a new enema program will answer online survey questions at 3 different timepoints over the course of 1 year.', 'detailedDescription': 'Spina bifida is a rare disease affecting an estimated 166,000 people in the United States. Because of the birth defect in the spinal cord, many organ systems do not work properly. Included among these affected organ systems are the bowels or intestines, which can lead to bowel incontinence or bowel accidents. Bowel incontinence is very disruptive to the lives of people with spina bifida by affecting their ability to have romantic relationships, find jobs, and overall enjoy their lives. The spina bifida community has recognized bowel incontinence as a top priority for research.\n\nTypically, reducing bowel incontinence and improving bowel continence occurs in a stepwise fashion. After medications by mouth such as laxatives or stool softeners, 2nd line treatments include enema programs. Two types of enema programs currently exist, those given in either a backward direction (given through the anus or end of the large intestine or colon) or in a forward direction (given through a tube that enters the start of the large intestine or colon). These two types of enema programs have different positives and negatives which have not been compared nor studied well. The lack of evidence on which is the better enema program presents a key decisional dilemma for many people with spina bifida who want to improve their bowel continence.\n\nIn the current study, the study team will compare the two types of enema programs in 943 children and adults ages 5 years old and up with spina bifida at 24 centers across the United States. The enema programs will be assigned to and started by the participants as part of usual clinical care from their local clinical team. At 6 months and 12 months over a 1-year study period, the study team will look at how the two types of enema programs compare in bowel continence (how well they work to prevent bowel accidents), quality of life (how much people enjoy their lives), bowel symptoms (how well they work to reduce bowel-related symptoms), self-management and independence (how well people can do these enema programs themselves without help), and healthcare utilization (how often these enema programs cause problems needing medical help). The study team will also ask 20 children with spina bifida, 20 adults with spina bifida, and 20 caregivers of children and adults with spina bifida more detailed interview questions about their lived experiences with managing bowel incontinence and their thoughts on how best to start and maintain a successful enema program. The expected study results will help people with spina bifida not only improve their bowel continence, but also their quality of life.\n\nThe study team is working with patient and family partners within the spina bifida community, healthcare providers across numerous disciplines, national advocacy organizations (the Spina Bifida Association), and industry partners who make enema devices to design and conduct this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children, adolescents, and adults age 5 years and older with spina bifida starting a new enema program at one of 24 participating clinical centers in the United States.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age 5 years old\n* Myelomeningocele diagnosis\n* Starting a retrograde or antegrade enema program (or switching from one enema program to the other)\n* English or Spanish speaking/literate\n\nExclusion Criteria:\n\n\\- Other types of spinal dysraphism (e.g., lipomyelomeningocele, fatty filum)'}, 'identificationModule': {'nctId': 'NCT07390318', 'acronym': 'BCALS', 'briefTitle': 'Bowel Continence Across the Lifespan in People With Spina Bifida', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Comparing Antegrade Versus Retrograde Enemas To Improve Bowel Continence Across the Lifespan in People With Spina Bifida', 'orgStudyIdInfo': {'id': 'STUDY00000320'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrograde Enema', 'description': 'Participants starting a retrograde enema program, as part of standard care prescribed by their local clinical team.', 'interventionNames': ['Procedure: Retrograde Enema']}, {'label': 'Antegrade Enema', 'description': 'Participants starting an antegrade enema program, as part of standard care prescribed by their local clinical team.', 'interventionNames': ['Procedure: Antegrade Enema']}], 'interventions': [{'name': 'Retrograde Enema', 'type': 'PROCEDURE', 'description': 'A retrograde enema is a bowel management technique in which the enema is given through the rectum (end of the colon). This includes cone enemas, foley balloon enemas, and Transanal irrigation (e.g. Peristeen, Navina).', 'armGroupLabels': ['Retrograde Enema']}, {'name': 'Antegrade Enema', 'type': 'PROCEDURE', 'description': 'An antegrade enema is a bowel management technique in which an enema is given through a surgically-created tube that enters at the start of the colon. This includes MACES, cecostomy buttons, and Chait tubes.', 'armGroupLabels': ['Antegrade Enema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital of Colorado", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Hospital", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Monroe Carell Jr. Children's Hospital at Vanderbilt", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'Scottish Rite for Children', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Josephine Hirsch', 'role': 'CONTACT', 'email': 'jahirsch@luriechildrens.org', 'phone': '312-227-6076'}, {'name': 'Ilina Rosoklija', 'role': 'CONTACT', 'email': 'irosoklija@luriechildrens.org', 'phone': '312-227-6409'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Chu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Attending Physician, Urology; Associate Professor of Urology at Northwestern University Feinberg School of Medicine', 'investigatorFullName': 'David Chu', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}