Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 2:58 PM
Study NCT ID:
NCT01848366
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Utilization of the BIOWAVE Device to Treat Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kenneth.Peters@Beaumont.org', 'phone': '248-551-0387', 'title': 'Dr. Kenneth Peters', 'organization': 'William Beaumont Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the small number of subjects enrolled, the results of this preliminary study are limited and not generalizable.'}}, 'adverseEventsModule': {'timeFrame': '13 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Biowave Treatment', 'description': 'Twelve weekly treatments\n\nBiowave Treatment: Twelve weekly treatments', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Response Assessment (GRA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biowave Treatment', 'description': 'Twelve weekly treatments\n\nBiowave Treatment: Twelve weekly treatments'}], 'classes': [{'title': 'Bladder Symptoms', 'categories': [{'measurements': [{'value': '5.25', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'Urine Leakage with Activity', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'Urge Incontinence', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}]}]}, {'title': 'Urinary Frequency', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'Urinary Urge', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}]}]}, {'title': 'IC/BPS', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Fecal Incontinence', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}]}]}, {'title': 'Irritable Bowel Symptoms', 'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biowave Treatment', 'description': 'Twelve weekly treatments\n\nBiowave Treatment: Twelve weekly treatments'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Biowave Treatment', 'description': 'Twelve weekly treatments\n\nBiowave Treatment: Twelve weekly treatments'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2013-05-02', 'resultsFirstSubmitDate': '2016-08-12', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-13', 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Response Assessment (GRA)', 'timeFrame': '3 months', 'description': 'The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Frequency', 'urgency', 'incontinence'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. The investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.', 'detailedDescription': 'Women 18 years old and over with a score of equal to or greater than 4 on the OAB-q short form for urgency and average daily urinary frequency equal to or greater than 10 times based on a 3-day voiding diary plus other inclusion criteria will be reviewed for possible enrollment in this study. Outcomes measured include Global Response Assessment (GRA) for overall bladder symptoms, a change in the 3-day voiding diary parameters and adverse events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women \\>18 years of age\n* A score of \\> 4 on the OAB-q short form for urgency (question 1)\n* Average daily urinary frequency \\> 10 times based on a 3-day voiding diary\n* Self-reported bladder symptoms present \\> 3 months\n* Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)\n* Off all antimuscarinics for at least 2 weeks prior to enrollment\n* Capable of giving informed consent\n* Ambulatory and able to use a toilet independently, without difficulty\n* Capable and willing to follow all study-related procedures\n\nExclusion Criteria:\n\n* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period\n* Neurogenic bladder\n* Botox® use in bladder or pelvic floor muscles in the past year\n* Pacemakers or implantable defibrillators\n* Primary complaint of stress urinary incontinence\n* Current urinary tract infection (UTI)\n* Current vaginal infection\n* Current use of InterStim®\n* Current use of Bion®\n* Previously been treated with Percutaneous Tibial Nerve Stimulation (PTNS)\n* Use of investigational drug/device therapy within the past 4 weeks.\n* Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function.\n* Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including skin disorders at the treatment site or peripheral neuropathy).\n* Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function."}, 'identificationModule': {'nctId': 'NCT01848366', 'acronym': 'OAB', 'briefTitle': 'Utilization of the BIOWAVE Device to Treat Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Biowave Overactive Bladder (OAB) Trial', 'orgStudyIdInfo': {'id': '2013-034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biowave Treatment', 'description': 'Twelve weekly treatments', 'interventionNames': ['Device: Biowave Treatment']}], 'interventions': [{'name': 'Biowave Treatment', 'type': 'DEVICE', 'description': 'Twelve weekly treatments', 'armGroupLabels': ['Biowave Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Kenneth M Peters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kenneth Peters, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Urology', 'investigatorFullName': 'Kenneth Peters, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}