Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT06763861
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biopsies from the external anal sphincter muscle.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of sacral neuromodulation on the external anal sphincter muscle among patients with faecal incontinence', 'timeFrame': '2 years - The biopsies will be analysed and assessed continuously.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fecal Incontinence', 'Sacral neuromodulation', 'Surgery', 'Pathology', 'Proctology', 'Quality of Life', 'Health status'], 'conditions': ['Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'This innovative project aims to investigate structures and morphology of the external anal sphincter (EAS) as well as the impact of sacral neuromodulation (SNM) on the EAS morphology and biochemistry among patients with faecal incontinence (FI).\n\nSNM is a well implemented treatment for FI and consist of electrical stimulation of sacral nerve roots to promote continence and may even contribute to total continence. It has shown a positive effects on both short- and long-term. The biologic effect of SNM on EAS is unknown.\n\nThe aim is to investigate the effect of SNM on EAS morphology, function, and biochemistry to help physicians and researchers to understand the underlying mechanisms of SNM and the anal sphincter complex to further improve and optimize treatment methods for patients with FI.\n\nThe research project consists of three phases. The first phase includes biopsies from the EAS among patients with no previous history of FI. These patients have been diagnosed with rectal cancer and will undergo surgery with abdominoperineal excision.\n\nThe second phase includes patients diagnosed with FI and subject for implantation of SNM for treatment of FI. Prior to implantation of SNM all patients will have been examined with 3D endo-anal ultrasound and anorectal manometry as well as answered questionnaires targeting general health, bowel dysfunction and FI. A biopsy of the superficial portion of the EAS is retrieved under local anaesthesia in connection to the test period for implantation of the SNM device.\n\nThe last phase, phase three, includes 3D endo-anal ultrasound, anorectal manometry, and a second biopsy of the EAS twelve months after implantation with SNM.\n\nThe histopathological analysis in all the three phases will include general morphology, distribution of cell nuclei, satellite cells, muscle fiber type, neural structures and connective tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Please see Study description.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Phase 1\n\nInclusion Criteria:\n\n* ≥ 18 years of age\n* Male or female\n* Diagnosed with rectal cancer and receive treatment with abdominoperineal resection\n* Signed an informed consent\n\nExclusion Criteria:\n\n* Previous diagnosis of FI\n* Unable to speak and/or read Swedish to ensure informed consent\n* Tumour involving the sphincter complex or is in close connection\n\nPhase 2 and 3\n\nInclusion Criteria:\n\n* Diagnosed with FI and will receive treatment with sacral neuromodulation\n* Male or female\n* Signed an informed consent\n\nExclusion Criteria:\n\n* Unable to speak and/or read Swedish to ensure informed consent'}, 'identificationModule': {'nctId': 'NCT06763861', 'acronym': 'SFINX', 'briefTitle': 'Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'SFINX - Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter', 'orgStudyIdInfo': {'id': 'Dnr 2024-04527-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without diagnosis of FI', 'description': 'Biopsies from EAS among patients diagnosed with rectal cancer and no records of previous diagnosis of FI and now receiving treatment with abdominoperineal resection.', 'interventionNames': ['Other: Biopsy']}, {'label': 'Patients diagnosed with FI', 'description': 'Biopsies from EAS among patients diagnosed with FI and recieving treatment with sacral neuromodulation before implantation of the device and 12 months postoperatively.', 'interventionNames': ['Other: Biopsy']}], 'interventions': [{'name': 'Biopsy', 'type': 'OTHER', 'description': 'Biopsies from EAS', 'armGroupLabels': ['Patients diagnosed with FI', 'Patients without diagnosis of FI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Umeå', 'state': 'Västerbotten County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Karin Strigård, Prof., Senior consultant', 'role': 'CONTACT'}], 'facility': 'Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Strigård, Prof., Senior consultant', 'role': 'CONTACT', 'email': 'karin.strigard@umu.se', 'phone': '+46(0)90 785 00 00'}, {'name': 'Louise Almkvist, MD', 'role': 'CONTACT', 'email': 'louise.almkvist@umu.se', 'phone': '+46(0)90 785 00 00'}], 'overallOfficials': [{'name': 'Karin Strigård, Prof., Senior consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Diagnostics and Interventions, Umeå University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}