Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 7:43 PM
Study NCT ID:
NCT04710433
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2021-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071056', 'term': 'Anorectal Malformations'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-18', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms: Change in defecation frequency', 'timeFrame': 'Baseline and 12 weeks after start of therapy', 'description': 'Defecation frequency is measured by bowel movements per week.'}, {'measure': 'Symptoms: Change in defecation consistency', 'timeFrame': 'Baseline and 12 weeks after start of therapy', 'description': 'Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency).'}, {'measure': 'Symptoms: Change of encopresis/soiling', 'timeFrame': 'Baseline and 12 weeks after start of therapy', 'description': 'Episodes of encopresis/soiling are evaluated per day.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline and 12 weeks after start of therapy', 'description': "The quality of life is classified via the 'Revised Children's Quality of Life Questionnaire' (KINDLR). It consists of 24 5-point Likert-scale items, covering 6 quality of life dimensions: physical well-being, emotional well-being, self-esteem, family, friends and daily functioning (school or nursery school/kindergarten). Items are partially reverse scored and linearly transformed to a 0 to 100 scale according to the manual. Higher scores indicate a better quality of life."}], 'secondaryOutcomes': [{'measure': 'Symptoms: Change of abdominal pain', 'timeFrame': 'Baseline and 12 weeks after start of therapy', 'description': 'Abdominal pain is recorded in episodes per week and its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sacral Nerve Stimulation', 'Neuromodulation'], 'conditions': ['Chronic Constipation With Overflow', 'Encopresis With Constipation and Overflow Incontinence', "Hirschprung's Disease", 'Anorectal Malformations']}, 'referencesModule': {'references': [{'pmid': '32373563', 'type': 'BACKGROUND', 'citation': 'Besendorfer M, Kohl M, Schellerer V, Carbon R, Diez S. A Pilot Study of Non-invasive Sacral Nerve Stimulation in Treatment of Constipation in Childhood and Adolescence. Front Pediatr. 2020 Apr 16;8:169. doi: 10.3389/fped.2020.00169. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients', 'detailedDescription': 'Patients are selected according to the eligibility requirements. After being informed about the study and potential risks of neuromodulation, all included patients and next of kin give written informed consent to the study.\n\nAt baseline, patients are classified to one of the two predefined subgroups: either medical and behavioral therapy is extended and optimized or neuromodulatory treatment is started with non-invasive sacral nerve stimulation via single current and two external adhesive electrodes. Within 12 weeks, treatment success is evaluated in routine clinical check-ups (week 4/8/12) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age between 2-17 years\n* informed consent\n* chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling\n* refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training)\n* exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism)\n* in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies\n* in cases of anorectal malformation: post-surgical status\n\nExclusion Criteria:\n\n* metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options\n* toxic megacolon or further emergencies, which must be treated surgically\n* fractures or substantial differences in the sacral anatomy\n* inflammatory bowel disorders\n* rectal prolapse\n* neuronal malignancies under medical and radiation therapy\n* seizures"}, 'identificationModule': {'nctId': 'NCT04710433', 'briefTitle': 'Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}, 'officialTitle': 'Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment', 'orgStudyIdInfo': {'id': '18_20B1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-invasive Neuromodulation', 'description': 'Application of non-invasive sacral nerve stimulation for 12 weeks, at least 8 hours per day.\n\nTwo adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field with a 15 Hz frequency for a duration of 210µs. Stimulation intensity is individually determined to achieve an effective and comfortable stimulation beyond the pain threshold (adjustable amplitude between 0-10mA).\n\nMedical and behavioral therapy is to be continued as started before intervention.', 'interventionNames': ['Device: Non-invasive Neuromodulation']}, {'type': 'OTHER', 'label': 'Medical/behavioral Therapy', 'description': 'Patients receive an optimized conventional treatment for 12 weeks, including lifestyle changes, toilet training and weight-adjusted medication. Conventional medical options include oral laxative medication with polyethyleneglycol or rectal medication with saline enemas in possible combination with a stimulant laxative (glycerin or bisacodyl).', 'interventionNames': ['Other: Medical and Behavioral Therapy']}], 'interventions': [{'name': 'Non-invasive Neuromodulation', 'type': 'DEVICE', 'description': 'Sacral nerve stimulation via two adhesive electrodes (single current).', 'armGroupLabels': ['Non-invasive Neuromodulation']}, {'name': 'Medical and Behavioral Therapy', 'type': 'OTHER', 'description': 'Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.', 'armGroupLabels': ['Medical/behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Sonja Diez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}, {'name': 'Manuel Besendörfer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Dr. med. Sonja Diez', 'investigatorAffiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}}}}