Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-25 @ 3:35 AM
Study NCT ID:
NCT06597994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmenting Urinary Reflex Activity: Study 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-09-13', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in absolute recharge performance', 'timeFrame': '48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months', 'description': 'Change in perceived recharge usability before and after receiving new recharge accessories and training.'}, {'measure': 'Change in relative recharge performance', 'timeFrame': '48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months', 'description': 'Relative (percentage) change in frequency and duration of recharging sessions after receiving new recharge accessories and training compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in recharge usability', 'timeFrame': '48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months', 'description': '% of time the device is fully operational and available for use after receiving new recharge accessories and training compared to baseline'}, {'measure': 'Fully adaptive mode usability', 'timeFrame': '48 hours; 2 months; 8 months', 'description': 'Change in frequency, severity and impact on quality of life of urinary incontinence episodes as assessed by Short Form version of the International Consultation on Incontinence urinary questionnaire (ICIQ-UI SF) after receiving fully adaptive firmware update and training compared to baseline. The ICIQ-UI SF is a 4 item simple questionnaire with minimum value of 0 and maximum value of 21 with higher scores indicating higher severity of UI symptoms and their impact on health-related quality of life.'}, {'measure': 'Fully adaptive mode specificity', 'timeFrame': '48 hours; 2 months; 8 months', 'description': 'Change in quality of life in relation to change in obstructive symptoms, irritative symptoms and stress symptoms as assessed by the Long Form version of the Urogenital Distress Inventory (UDI-LF) after receiving fully adaptive firmware update and training compared to baseline. The UDI-LF consists of 19 questions and total scores are converted to a score range of 0-300, with higher scores representing greater symptom distress.'}, {'measure': 'Adverse Device Events', 'timeFrame': '48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months', 'description': 'Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has exited the AURA-2 clinical investigation.\n* Participant has an implanted Amber UI system.\n* Consents to participation.\n\nExclusion Criteria:\n\n* Participant has withdrawn from AURA-2 clinical investigation.\n* Participant is pregnant.\n* A past or current condition that in the opinion of the PI contraindicates enrolment (PI discretion).'}, 'identificationModule': {'nctId': 'NCT06597994', 'acronym': 'AURA-3', 'briefTitle': 'Augmenting Urinary Reflex Activity: Study 3', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amber Therapeutics Ltd'}, 'officialTitle': 'Therapy Optimisation Study of Adaptive Pudendal Neuromodulation in Women With Urinary Incontinence Implanted With the Amber UI System.', 'orgStudyIdInfo': {'id': 'TS-01388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amber UI Therapy', 'description': 'Participants will receive optimised recharge accessories and device firmware upgrades', 'interventionNames': ['Device: Amber UI system']}], 'interventions': [{'name': 'Amber UI system', 'type': 'DEVICE', 'description': 'Upgrade of Amber UI system recharge accessories and system firmware', 'armGroupLabels': ['Amber UI Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Stefan De Wachter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amber Therapeutics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}