Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-28 @ 9:37 PM
Study NCT ID:
NCT04547920
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FREEOAB Study for Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], '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'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'customercare@avation.com', 'phone': '(614) 591-4201', 'title': 'Clinical Operations Project Manager', 'organization': 'Avation Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Potential limitations exist in the inherent design of the trial with use of patient-reported outcomes. This trial also had no control arm and relied on placebo rates available in the published literature. The end points were refined based on FDA feedback and the data was analyzed post-hoc. The opt-in process for the long-term follow-up population may have skewed in favor of patients with better outcomes during Phase I of the study and led to low number of subjects who entered Phase II.'}}, 'adverseEventsModule': {'timeFrame': 'Length of Study (12 months)', 'eventGroups': [{'id': 'EG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 17, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pollakiuria (Frequent Urination)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot Pain / Intense Stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Spasm (Foot Cramping)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia (Tingling Sensation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicose Veins', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Responders in Voiding (Urinary Frequency) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'The percentage of responders in voiding (urinary frequency) events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total voids per day relative to an upper normal limit of 8 voids per day, or returns to normal (8 or fewer voids per day) at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Subjects with Reported Voiding Symptom (Avg \\> 8 / day) at Baseline'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders in Incontinence (Leak) Events (IE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Percentage of Responders in Incontinence (Leak) Events (IE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total incontinence events per day, or returns to normal (0 events per day), at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Subjects with Reported Urgency Symptom (Avg Daily Urges \\> 0) at Baseline'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders in Urgency Events (UE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Percentage of Responders in Urgency Events (UE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total urgency events per day, or returns to normal (0 events per day) at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Subjects with Reported Incontinence Symptom (Avg Daily Leaks \\> 0) at Baseline'}, {'type': 'SECONDARY', 'title': 'Overall Responder Rate at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Weeks', 'description': 'Overall Responder Rate at 12 Weeks, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Subjects with ≥ 50% Change in Any Symptom'}, {'type': 'SECONDARY', 'title': 'Overall Responder Rate at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'Overall Responder Rate at 12 Months, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '\\# of Subjects with ≥ 50% Change in Any Symptom'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.'}], 'periods': [{'title': 'Initial 12-Week Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}, {'title': 'Optional 12-Month Long Term Follow-Up', 'milestones': [{'type': 'STARTED', 'comment': 'The Long Term Follow-Up portion of the trial was optional so not every subject who completed the 12-Week portion opted to enter into this portion of the trial.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to complete therapy with a wearable closed-loop, continuous sensing tibial nerve stimulation device for bladder modulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy for the duration of the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White / Caucasian', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}, {'title': 'Black / African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '164', 'spread': '9.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.7', 'spread': '26.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-15', 'size': 907899, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-06T15:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2020-09-08', 'resultsFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-06', 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Responders in Voiding (Urinary Frequency) Events', 'timeFrame': '12 Weeks', 'description': 'The percentage of responders in voiding (urinary frequency) events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total voids per day relative to an upper normal limit of 8 voids per day, or returns to normal (8 or fewer voids per day) at Week 12.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders in Incontinence (Leak) Events (IE)', 'timeFrame': '12 Weeks', 'description': 'Percentage of Responders in Incontinence (Leak) Events (IE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total incontinence events per day, or returns to normal (0 events per day), at Week 12.'}, {'measure': 'Percentage of Responders in Urgency Events (UE)', 'timeFrame': '12 Weeks', 'description': 'Percentage of Responders in Urgency Events (UE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total urgency events per day, or returns to normal (0 events per day) at Week 12.'}, {'measure': 'Overall Responder Rate at 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'Overall Responder Rate at 12 Weeks, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at Week 12.'}, {'measure': 'Overall Responder Rate at 12 Months', 'timeFrame': '12 Months', 'description': 'Overall Responder Rate at 12 Months, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at 6 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Neuromodulation', 'Closed-Loop Neuromodulation', 'Wearable Neuromodulation', 'Tibial Nerve Stimulation', 'Continuous Sensing', 'Automatic Adjustment'], 'conditions': ['Overactive Bladder', 'Urinary Frequency', 'Urinary Incontinence, Urge', 'Urinary Urgency']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female and 18 years of age or older at the time of enrollment\n2. Willing and capable of giving informed consent\n3. Willing and able to comply with study-related requirements and procedures\n4. Are an appropriate candidate for the system required in this study based on the clinical judgment of the Investigator.\n5. Have been diagnosed or have symptoms of OAB for at least 3 months Page 8 of 30 Version 1.0 dated July 06, 2020 prior to enrollment\n6. Have an average of 10 or more frequency events per day in a 3-Day Voiding Diary\n7. Able to provide clear, thoughtful responses to questions and questionnaires\n8. Able to toilet self and have and maintain personal hygiene\n9. Able to don and doff the bladder modulation garment on their ankle area, replace Gel Pads and use the controller\n10. Have ankle and foot anatomy that allows the garment to fit properly, including having the hook and loop closures close and without excessive gapping and allowing the electrodes to fit firmly on the skin.\n11. Able to sense and tolerate stimulation for the entire 30-minute therapy session\n12. Has detectable EMG signal in response to modulation system stimulation during an investigator supervised screening session\n13. If currently on medications that may affect their OAB symptoms, is on a stable dose (no new, discontinued, or change in dose) of all prescribed medication for at least 4 weeks prior to enrollment\n14. Female subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline\n15. Have access to Wi-Fi at least weekly\n16. Are capable of using the tablet-based controlling app\n\nExclusion Criteria:\n\n1. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes, in the opinion of the investigator.\n2. Allergic, or have shown hypersensitivity, to any materials of the system which come into contact with the body\n3. Have a pacemaker or implanted defibrillator\n4. Have a documented current or reoccurring Urinary Tract Infection (3 or more in the 12months prior to enrollment)\n5. Current use of a marketed device for treatment of their OAB or incontinence (including but not limited to Interstim®)\n6. Have had Botox treatment for their OAB in the previous 8 months\n7. Current use of transcutaneous electric nerve stimulation (TENS) in pelvic region, back or legs\n8. Had PTNS treatment within 6 months prior to enrollment\n9. Use of investigational drug/device therapy within past 12 weeks\n10. Is concomitantly participating in another clinical study\n11. Had within 6 months of enrollment a significant untreated substance abuse disorder or polysubstance abuse disorder stemming from dependency producing medications, alcohol, and/or illicit drugs\n12. Pregnant or planning to become pregnant within the next 12 weeks\n13. Has scar tissue, metal, or other implant in the target ankle that would interfere with stimulation\n14. Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia)\n15. Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas.\n16. Has a skin condition in the area of the ankle stimulation location that would preclude them from using surface stimulation\n17. Has been diagnosed with incontinence due to neurogenic bladder\n18. Have failed a third line treatment for their OAB because of lack of effectiveness in the last 2 years (PTNS, Botox, or SNS)\n19. Urge incontinence due to stress predominant mixed urinary incontinence (greater that 60% of the time)\n20. Have polyuria (\\>2500 cc urine output per day)\n21. Has urinary retention or incomplete bladder emptying\n22. Has symptoms of benign prostatic hyperplasia (BPH -weak stream, straining, hesitancy or intermittency)'}, 'identificationModule': {'nctId': 'NCT04547920', 'briefTitle': 'FREEOAB Study for Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avation Medical, Inc.'}, 'officialTitle': 'A Prospective Efficacy Study Comparing FREquency of Use and Efficacy of a Personalized Surgery-free Wearable and Personalized Bladder Modulation System With Objective Confirmation of Nerve Activation for Use in the Home by Subjects With OverActive Bladder Syndrome', 'orgStudyIdInfo': {'id': 'AMHOAB2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12 Weeks Followed by Optional 12 Month Continuation', 'description': 'Initial 12 Weeks: Patients were instructed to therapy using a wearable closed-loop, continuous sensing tibial nerve stimulation.\n\nOptional Months 4-12: Subjects who qualified for the long-term follow up and elected to enroll, signed a new informed consent and continued therapy sessions for the duration of the trial.', 'interventionNames': ['Device: Wearable Bladder Modulation System']}], 'interventions': [{'name': 'Wearable Bladder Modulation System', 'type': 'DEVICE', 'description': 'Wearable Closed-Loop, Continuous Sensing Tibial Nerve Stimulation Device', 'armGroupLabels': ['12 Weeks Followed by Optional 12 Month Continuation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Pelvic Solutions Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Pelvic Floor Consultants', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': "Women's Health Institute", 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46143', 'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Urology of Indiana', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48092', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute of Urology', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Tranquil Medical Rsearch', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avation Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}