Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT04027335
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2019-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-18', 'studyFirstSubmitDate': '2019-07-18', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "St. Mark's Incontinence Score", 'timeFrame': 'Baseline to 10 weeks', 'description': 'Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms'}], 'secondaryOutcomes': [{'measure': 'Change in Fecal incontinence episodes', 'timeFrame': 'Baseline to 10 weeks', 'description': 'Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.'}, {'measure': 'Fecal Incontinence Quality of Life Scale (FIQoL)', 'timeFrame': 'Change in score from baseline to 10 weeks', 'description': 'Validated Survey evaluates four areas- coping, depression, lifestyle and embarrassment. Each area is scored from 1-5. Higher numbers indicate more severe symptoms. Area scores are not combined'}, {'measure': "Cumulative adherence correlation with change in St. Mark's score", 'timeFrame': 'baseline to 10 weeks', 'description': "Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fecal incontinence', 'Women'], 'conditions': ['Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women', 'detailedDescription': 'Subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the Leva pelvic digital health system.\n\nSubjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training.\n\nAdherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence.\n\nSubjects are expected to participate in at least 80% of the weekly exercises (11 weekly).\n\nSubjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. At 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training.\n\nFollowing 10 weeks of training, subjects will be free to pursue any additional therapies, but will also retain the leva device and may continue its use if desired. Adherence will be monitored for one additional year, with follow up surveys to be completed by mail or digitally at 6- and 12-months'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Subject must have a vagina', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment\n3. Ambulatory\n\nExclusion Criteria:\n\n1. Absence of a vagina\n2. Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)\n3. Current or past diagnosis of colorectal or anal malignancy\n4. Diagnosis of inflammatory bowel disease\n5. Current or history of rectovaginal fistula or cloacal defect\n6. Rectal prolapse (mucosal or full thickness)\n7. Prior removal or diversion of any portion of colon or rectum\n8. Prior pelvic floor or abdominal radiation\n9. Refusal or inability to provide written consent\n10. Inability to utilize smart phone technology ("app" use)\n11. Fecal impaction by exam\n12. Stage 3 or 4 pelvic organ prolapse\n13. Incontinence only to flatus\n14. Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.\n15. Childbirth within the last 6 months\n16. Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson\'s disease and debilitating stroke\n17. Chronic abdominal pain in the absence of diarrhea\n18. Presence of an active (turned on) sacral neuromodulator within the last 6 months\n19. Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT04027335', 'briefTitle': 'Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Renovia, Inc.'}, 'officialTitle': 'Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study', 'orgStudyIdInfo': {'id': 'REN-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leva Arm', 'description': 'Subjects will undergo training in the use of a vaginal device and its associated app, to be used twice daily to perform pelvic floor muscle exercises guided by the device/app for 10 weeks.', 'interventionNames': ['Device: leva']}], 'interventions': [{'name': 'leva', 'type': 'DEVICE', 'description': 'Vaginal device used for pelvic floor muscle exercises', 'armGroupLabels': ['Leva Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Holly Richter, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renovia, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}