Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 3:32 PM
Study NCT ID:
NCT02336906
Status:
WITHDRAWN
Last Update Posted:
2018-04-11
First Post:
2015-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053207', 'term': 'Diurnal Enuresis'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D004775', 'term': 'Enuresis'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595212', 'term': 'polyethylene glycol 3350'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Changes in departmental staff have led to a cut in research alotments.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2015-01-01', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response in patient subgroups with fecal loading compared to those without fecal loading.', 'timeFrame': '14 weeks', 'description': 'Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response to therapy in those with radiological evidence of fecal loading on enrollment abdominal x-ray (as defined by rectal/pelvic outlet ratio, Leech score, and Barr score) compared to those who did not in the intervention group and the urotherapy group'}, {'measure': 'Sustained Response - Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response 12 weeks after intervention has ended.', 'timeFrame': '26 weeks'}, {'measure': 'Number of participants with adverse effects', 'timeFrame': '14 weeks', 'description': 'Adverse effects of interventions as reported by patients/care givers during visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lower urinary tract dysfunction', 'constipation'], 'conditions': ['Diurnal Enuresis']}, 'referencesModule': {'references': [{'pmid': '19695637', 'type': 'BACKGROUND', 'citation': 'Afshar K, Mirbagheri A, Scott H, MacNeily AE. Development of a symptom score for dysfunctional elimination syndrome. J Urol. 2009 Oct;182(4 Suppl):1939-43. doi: 10.1016/j.juro.2009.03.009. Epub 2009 Aug 20.'}, {'pmid': '22173180', 'type': 'BACKGROUND', 'citation': 'Hodges SJ, Anthony EY. Occult megarectum--a commonly unrecognized cause of enuresis. Urology. 2012 Feb;79(2):421-4. doi: 10.1016/j.urology.2011.10.015. Epub 2011 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'Constipation treatment has been found to ameliorate symptoms in some patients with lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to anti-constipation treatment with reduction of their urinary tract symptoms. Assessment of severity and response of lower urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 5-17 years at time of signing of informed consent.\n2. Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of \\>11 on the Vancouver Questionnaire .\n3. Do not meet Rome III criteria for functional constipation.\n\nExclusion Criteria:\n\n1. Inability to provide signed informed consent.\n2. Inability to comply with the study protocol.\n3. Neurogenic bladder\n4. Attention Deficit Disorder (ADD or ADHD) on medical treatment.\n5. Known significant sacral, perineal, or other congenital or surgical defect.\n6. Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)\n7. Patient taking medicinal drugs which can cause urinary incontinence or constipation.'}, 'identificationModule': {'nctId': 'NCT02336906', 'briefTitle': 'Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Lower Urinary Tract Dysfunction (LUTD) Not Meeting ROME-III Constipation Criteria', 'orgStudyIdInfo': {'id': 'rmc130348ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Urotherapy + Constipation Treatment', 'description': 'This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.', 'interventionNames': ['Drug: polyethylene glycol 3350', 'Behavioral: Constipation behavioral therapy', 'Behavioral: Urotherapy']}, {'type': 'OTHER', 'label': 'Urotherapy alone', 'description': 'This group will receive standard behavioral urotherapy alone.', 'interventionNames': ['Behavioral: Urotherapy']}], 'interventions': [{'name': 'polyethylene glycol 3350', 'type': 'DRUG', 'otherNames': ['PEG3350', 'Normalax'], 'description': 'Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and the stepped down to 0.8gr/kg subsequently tapered according to stool consistency and frequency.', 'armGroupLabels': ['Urotherapy + Constipation Treatment']}, {'name': 'Constipation behavioral therapy', 'type': 'BEHAVIORAL', 'description': 'Patients in the active group will receive dietary instruction as to fiber content, as well as behavior therapy including active sitting on the toilet to attempt defacation following meals.', 'armGroupLabels': ['Urotherapy + Constipation Treatment']}, {'name': 'Urotherapy', 'type': 'BEHAVIORAL', 'description': 'The children will be guided for appropriate drinking and toilet habits, and will start with timed voiding.', 'armGroupLabels': ['Urotherapy + Constipation Treatment', 'Urotherapy alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49202', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Institute of Gastroenterology, Nutrition, and Liver Diseases; Schneider Children's Medical Center of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Gastroenterologist', 'investigatorFullName': 'Noam Zevit', 'investigatorAffiliation': 'Rabin Medical Center'}}}}