Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT03969069
Status:
UNKNOWN
Last Update Posted:
2019-05-31
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Faecal Incontinence With MAPLe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-13', 'size': 1103800, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-28T09:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Which patient groups benefit from assessment with MAPLe?', 'timeFrame': '12 months', 'description': 'Identity correlation between symptom profile and MAPLe results'}, {'measure': 'Non-inferiority testing of MAPLe against current ano-rectal physiological tests.', 'timeFrame': '12 months', 'description': 'Blank Altman analysis of MAPLE vs HRAM and MAPLe vs AUS'}], 'secondaryOutcomes': [{'measure': 'Has directed treatment been achieved?', 'timeFrame': '18 months', 'description': 'Identify EMG activity in participants who underwent treatment, compare with pre-treatment EMG'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Adult', 'Human', 'Cohort'], 'conditions': ['Faecal Incontinence', 'Fecal Incontinence', 'Faecal Incontinence With Faecal Urgency']}, 'descriptionModule': {'briefSummary': 'Faecal incontinence (FI) is the involuntary passage of gas, liquid or solid stool and is experienced by an estimated 1-10% of the population. The symptom is multifactorial and associated with many medical conditions and diseases. The symptom is investigated using structural and functional testing of the pelvic floor. Current investigation techniques have poor correlation between symptom severity and investigation results. These techniques are unable to provide prognostic outcomes, resulting in undirected referrals for treatment based on symptoms alone. This study aims to improve the assessment of FI through additional testing using Multiple Array Probe Leiden (MAPLe). This is a non-invasive medically certified device that detects the electromyography of the pelvic floor, how muscles respond to voluntary nervous stimulus, to identify areas of weakness.\n\nThe aim of this study is firstly to identify which patient groups benefit from additional testing with MAPLe, and secondly to identify if directed treatment has been achieved.\n\nThe study will take place across two NHS trusts, both with specialist pelvic floor services. Participants referred to each trust with FI who meet the inclusion/exclusion criteria will be recruited from designated pelvic floor clinics and referrals for anorectal physiology (ARP). Each participant will undergo routine anorectal physiological assessment with Anal Ultrasound (AUS) and High Resolution Anal Manometry (HRAM) and additional assessment with MAPLe. Participation is complete unless treatment has been advised, these participants will undergo repeat assessment with MAPLe at 6 months. Average participation will be 12 months.\n\nThe results will be analysed to identify non-inferiority of MAPLe vs current techniques using Bland Altman method. Regression and correlation studies will be performed to identify which groups have benefited from assessment with MAPLe. An expert panel of specialists in the field of pelvic floor will be convened to determine the clinical utilisation of MAPLe.', 'detailedDescription': "This is cohort study of participants with symptoms of faecal incontinence. The study will take place across two hospital trusts, Ashford and St Peter's NHS Foundation Trust (ASPH) and University Hospital London Hospitals NHS Foundation Trust (UCLH). These trusts have been selected as both provide specialist pelvic floor services and have the facilities required to meet the needs of the study and follow up required by the participants. The use of two sites aims to increase the yield and diversity of participants.\n\nReferrals to each trust are triaged by the overseeing consultant. Potential participants for the study will be identified. At ASPH suitable referrals will be tracked to a dedicated pelvic floor clinic run by a trial representative with medical training. Participants who meet the inclusion/exclusion criteria will be offered a patient information sheet and given an appointment in a dedicated anorectal physiology session (ARP). At UCLH suitable referrals will be contacted via telephone by the PI, should they wish to enrol they will receive a PIS and given an appointment in a dedicated ARP session. Participants will only be assessed and followed up in their recruiting trust.\n\nAll participants will complete an incontinence questionnaire and a quality of life questionnaire. Each participant will attend a designated ARP session. At ASPH this will comprise of the current gold standard, Anal Ultrasound (AUS) and High resolution manometry (HRAM) and additional assessment with MAPLe using a standardised protocol. At UCLH participants will undergo AUS in the radiology department, and HRAM and MAPLe in the GI Physiology unit. Through undertaking all three tests participants will act at their own controls. The results will be made available to their overseeing consultant and discussed at their local MDT. Participant participation will conclude following ARP assessment unless treatment is deemed necessary by their local MDT. These participants will be followed up at 6 months with interval MAPLe assessment and incontinence and quality of life questionnaire.\n\nThe results will undergo statistical analysis to determine non-inferiority of MAPLe in assessing FI. For analysis participants will be allocated to the following groups: fistula/chronic perianal conditions, obstetric injury \\<12 months, obstetric injury \\>12months, neurogenic. Each group will be analysed using symptoms profile and MAPLe results to identify correlation. Comparison of MAPle results pre and post treatment will determine if targeted treatment has been achieved.\n\nAn expert panel of pelvic floor specialists will be formed to determine the additional benefit of MAPLe in a clinical context. The panel will consist of 3-6 specialists within the field. To reduce bias, each specialist will be provided with literature on the background of MAPLe and how to analyse the results. The panellists will receive up to date guideline on the management of FI. The panel will be provided with cases and ARP results to answer the following questions:\n\nQuestion 1: What is the additional benefit of MAPLe?\n\n* Panellists will be provided with clinical history HRAM and AUS results\n\n ▪ What is the diagnosis and how will you manage this patient?\n* MAPLe results provided\n\n * Has the management changed?\n * How beneficial on scale 1-10 has the addition been? Question 2 : HRAM and AUS vs MAPLe and AUS\n* Panellists will be provided with a series of paired histories set one with HRAM and AUS results, set two with MAPLe and AUS results\n\n * What is the diagnosis and treatment?\n * How confident do you feel in your diagnosis and treatment for set two? Question 3: MAPLe alone\n* Panellists will be provided with history and MAPLe results\n* What is the diagnosis and treatment?\n* Do you feel enough information is provided by the MAPLe to allow for a management plan?\n\nThe outcomes of the expert panel will undergo statistical analysis. determine if there is a perceived benefit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All persons symptomatic of faecal incontinence with the capacity to consent and participate who meet the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of faecal incontinence\n* Capacity to consent\n\nExclusion criteria:\n\n* Anal surgery in the last 3 months\n* Anal cancer\n* Acute/painful perianal disease'}, 'identificationModule': {'nctId': 'NCT03969069', 'briefTitle': 'Assessment of Faecal Incontinence With MAPLe', 'organization': {'class': 'OTHER', 'fullName': 'University College London Hospitals'}, 'officialTitle': 'Improving the Assessment of Faecal Incontinence: Which Patient Groups Would Benefit From Assessment With Multiple Array Probe Leiden (MAPLe)?', 'orgStudyIdInfo': {'id': '119731'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fistula/chronic perianal conditions', 'description': 'Participants symptomatic of FI with chronic perianal disease', 'interventionNames': ['Device: MAPLe']}, {'label': 'Obstetric injury <12 months', 'description': 'Participants symptomatic of FI \\< 12 months following obstetric injury.', 'interventionNames': ['Device: MAPLe']}, {'label': 'Obstetric injury >12 months', 'description': 'Participants symptomatic of FI \\>12 months following obstetric injury.', 'interventionNames': ['Device: MAPLe']}, {'label': 'Neurogenic', 'description': 'Participants symptomatic of FI with evidence/history of neurological condition.', 'interventionNames': ['Device: MAPLe']}], 'interventions': [{'name': 'MAPLe', 'type': 'DEVICE', 'description': 'Additional assessment with MAPLe', 'armGroupLabels': ['Fistula/chronic perianal conditions', 'Neurogenic', 'Obstetric injury <12 months', 'Obstetric injury >12 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT16 0PZ', 'city': 'Chertsey', 'state': 'Surrrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rachael C Weatherburn, MBChB, MRCS', 'role': 'CONTACT', 'email': 'rweatherburn@nhs.net', 'phone': '01932872000'}, {'name': 'Prateesh Trivedi, MBBS, FRCS', 'role': 'CONTACT', 'email': 'prateesh.trivedi@nhs.net', 'phone': '01932872000'}], 'facility': "St Peter's Hospital", 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}, {'zip': 'NW1 1BU', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rachael C Weatherburn, MBChB, MRCS', 'role': 'CONTACT', 'email': 'rweatherburn@nhs.net', 'phone': '020 3447 9130'}, {'name': 'Anton V Emmanuel, BSc,MD,FRCP', 'role': 'CONTACT', 'email': 'a.emmanuel@ucl.ac.uk', 'phone': '020 3447 9130'}], 'facility': 'University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Rachael C Weatherburn, MBChB MRCS', 'role': 'CONTACT', 'email': 'rweatherburn@nhs.net', 'phone': '020 3447 9130'}, {'name': 'Anton V Emmanuel, BSc, MD, FRCP', 'role': 'CONTACT', 'email': 'a.emmanuel@ucl.ac.uk', 'phone': '020 3447 9130'}], 'overallOfficials': [{'name': 'Rachael C Weatherburn, MBChB MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Fellow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Student research project, data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College London Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Rachael Weatherburn', 'investigatorAffiliation': 'University College London Hospitals'}}}}