Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 9:00 PM
Study NCT ID:
NCT05211193
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of severe urgency episodes', 'timeFrame': 'baseline and end of study (6weeks treatment)', 'description': 'The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder (OAB)', 'Failed Any OAB Pharmacotherapy']}, 'descriptionModule': {'briefSummary': 'Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.', 'detailedDescription': 'Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'females age 18 years or older. The women had a diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms. The women were dissatisfied with current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women 18 years or older, inclusive\n* Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms\n* Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months\n* Treatment Satisfaction VAS \\<50\n* Ability to understand and sign ICF\n* Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests\n* Subject agreed not to participate in another research study from the time of screening until the final study visit\n* Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit\n\nExclusion Criteria:\n\n* Prior treatment with botulotoxin for OAB\n* Previous pharmacotherapy for OAB if \\>12 months ago\n* Urinary retention with post void residual \\> 150ml\n* Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs\n* History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant"}, 'identificationModule': {'nctId': 'NCT05211193', 'briefTitle': 'Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stimvia s.r.o.'}, 'officialTitle': 'Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).', 'orgStudyIdInfo': {'id': 'TS003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'eTNM arm', 'description': "eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1- 42.", 'interventionNames': ['Device: eTNM delivered by URIS I nerve stimulation device']}], 'interventions': [{'name': 'eTNM delivered by URIS I nerve stimulation device', 'type': 'DEVICE', 'description': "eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1-42.", 'armGroupLabels': ['eTNM arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '261 01', 'city': 'Příbram', 'state': 'Czech', 'country': 'Czechia', 'facility': 'MUDr. Michal Rejchrt', 'geoPoint': {'lat': 49.68988, 'lon': 14.01043}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stimvia s.r.o.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}