Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-28 @ 2:25 AM
Study NCT ID:
NCT02396160
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2015-03-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053158', 'term': 'Nocturia'}], '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': 'D014555', 'term': 'Urination Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'n.schoendorfer@uq.edu.au', 'phone': '0413122076', 'title': 'Dr Niikee Schoendorfer', 'organization': 'University of Queensland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations of this study include the relatively short duration and lack of long-term follow up. As a phase 2 clinical trial, there was no active comparator and a smaller sample size was also utilized.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs', 'otherNumAtRisk': 69, 'otherNumAffected': 5, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment', 'otherNumAtRisk': 73, 'otherNumAffected': 8, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Episodes of diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache and worsened asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsened memory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Halitosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsened arthritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Day Urinary Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '7.68', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': '7.91'}, {'value': '10.95', 'groupId': 'OG001', 'lowerLimit': '10.70', 'upperLimit': '11.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary', 'unitOfMeasure': 'number of diurnal micturitions per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who met the criteria for this outcome being day urination frequency ≥10 daytime micturitions per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.'}, {'type': 'SECONDARY', 'title': 'Urinary Urgency Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '1.28', 'upperLimit': '1.71'}, {'value': '3.92', 'groupId': 'OG001', 'lowerLimit': '3.65', 'upperLimit': '4.19'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary', 'unitOfMeasure': 'number of urgency episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who met the criteria for this outcome being urgency urination frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.'}, {'type': 'SECONDARY', 'title': 'Urge Incontinence Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.54'}, {'value': '2.36', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '2.66'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary', 'unitOfMeasure': 'number of urge incontinence episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who met the criteria for this outcome being urge incontinent frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.'}, {'type': 'PRIMARY', 'title': 'Nocturia Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.16', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '2.29'}, {'value': '3.11', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '3.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary", 'unitOfMeasure': 'number of nocturnal micturitions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who met the criteria for this outcome being nocturnal frequency ≥2 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.'}, {'type': 'SECONDARY', 'title': 'Stress Incontinence Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.86'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.26', 'upperLimit': '1.94'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary', 'unitOfMeasure': 'Number of stress incontinence episodes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who met the criteria for this outcome being stress incontinence frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root\n\nUrox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose\n\nPlacebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.21', 'spread': '12.11', 'groupId': 'BG000'}, {'value': '62.26', 'spread': '13.87', 'groupId': 'BG001'}, {'value': '63.23', 'spread': '13.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.90', 'spread': '18.78', 'groupId': 'BG000'}, {'value': '79.73', 'spread': '22.74', 'groupId': 'BG001'}, {'value': '79.82', 'spread': '20.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Day urinary frequency', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants ≥10 daytime micturitions per day', 'unitOfMeasure': 'participants'}, {'title': 'Night urinary frequency', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants ≥2 nocturnal micturitions per night', 'unitOfMeasure': 'participants'}, {'title': 'Urgency', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants ≥2 urgency micturitions per day', 'unitOfMeasure': 'participants'}, {'title': 'Urge incontinence', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants ≥1 urge incontinent episode per day', 'unitOfMeasure': 'participants'}, {'title': 'Stress incontinence', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants ≥1 stress incontinent episodes per day', 'unitOfMeasure': 'participants'}, {'title': 'Any incontinence', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants ≥1 any incontinence episodes per day', 'unitOfMeasure': 'participants'}, {'title': '2 symptoms', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants reporting meeting 2 symptom criteria per day', 'unitOfMeasure': 'participants'}, {'title': '3 symptoms', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants reporting meeting 3 symptom criteria per day', 'unitOfMeasure': 'participants'}, {'title': '4 symptoms', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'number of participants reporting meeting 4 symptom criteria per day', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This data includes all those who met criteria (minimum of 2 of the following symptoms per day for 6 months - Urinary Day Frequency ≥10 daytime micturitions; Nocturia ≥2 night time micturitions; Urinary Urgency ≥2 episodes and/or Incontinence ≥1 episode) and were entered into randomisation at the commencement of their enrollment into the study'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-03', 'studyFirstSubmitDate': '2015-03-17', 'resultsFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-03', 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Day Urinary Frequency', 'timeFrame': '8 weeks', 'description': 'Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary'}, {'measure': 'Nocturia Frequency', 'timeFrame': '8 weeks', 'description': "Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary"}], 'secondaryOutcomes': [{'measure': 'Urinary Urgency Frequency', 'timeFrame': '8 weeks', 'description': 'Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary'}, {'measure': 'Urge Incontinence Frequency', 'timeFrame': '8 weeks', 'description': 'Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary'}, {'measure': 'Stress Incontinence Frequency', 'timeFrame': '8 weeks', 'description': 'Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['overactive bladder', 'urinary incontinence', 'nocturia', 'urinary frequency'], 'conditions': ['Overactive Bladder', 'Urinary Incontinence', 'Urinary Frequency or Urgency Adverse Event', 'Nocturia']}, 'referencesModule': {'references': [{'pmid': '29385990', 'type': 'DERIVED', 'citation': 'Schoendorfer N, Sharp N, Seipel T, Schauss AG, Ahuja KDK. Urox containing concentrated extracts of Crataeva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root, in the treatment of symptoms of overactive bladder and urinary incontinence: a phase 2, randomised, double-blind placebo controlled trial. BMC Complement Altern Med. 2018 Jan 31;18(1):42. doi: 10.1186/s12906-018-2101-4.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the efficacy of a specialized herbal formula, Urox, versus control over 8 weeks, in a double blind, placebo controlled trial. 150 participants are being recruited, randomized and administered treatment or placebo for the period of 8 weeks after initial eligibility screening. Outcome measures include previously validated tools such as the 3 day symptom diary measuring self-recorded day frequency, nocturia, urgency and incontinence episodes. Quality of life improvements are being measured using the Incontinence Impact Questionnaire, Urinary Distress Inventory and the short version of the OverActive Bladder survey.', 'detailedDescription': 'Initial consultations were held at either the Brisbane campus of the Endeavour College of Natural Medicine Naturopathic clinic or at Kelvin Grove Natural Medicine clinic, Brisbane. Follow up interviews are being conducted via telephone. To minimize dropout rates, participants are telephoned (as a reminder for the call and to complete the micturition diaries) approximately 1 week before the scheduled interview time and were intermittently called over the week following if they were unable to be reached at the scheduled interview time. Three attending clinicians interviewed trial participants, all having participated in interview training prior to any interviews being taken. The training was designed to ensure utility of a uniform and consistent approach regarding how questions were asked and how data was recorded.\n\nThe week prior to an initial consultation participants were requested to complete a micturition diary and health related quality of life surveys, to serve as baseline measures. The attending clinician then also completed a clinical data sheet, at the time of the initial consultation, containing a range of questions including demographics, exercise, health history and habits, which will be used to control and correlate data variables. Any incomplete quality of life surveys at the outset were also completed at the first interview.\n\nMicturition diaries are collected by post at 2, 4 and 8 week intervals along with the completion of quality of life surveys and follow up clinical data sheet via telephone. Participants were asked to keep the micturition diary for 3 days prior to each consultation and were provided reply paid envelopes to return the surveys and unused capsules to assess compliance.\n\nFor the primary outcome (day frequency) measure it was calculated that 90 participants equally divided into placebo and control were required to detect a difference of 1.6 urinary frequency episodes per day (2.7SD) between treatment and placebo groups, with a two-tailed alpha of 0.05 and a power of 80%. For total incontinence, 53 participants were required equally divided into each group to detect a difference of 1.2 episodes per day (2.2SD), while for urgency 54 was required in each group to detect a difference of 2 per day (3.7SD). To account for potential drop-outs and variations in presenting symptoms, a total of 150 participants were recruited.\n\nData for the two treatments will be compared using mixed effects ordered logistic regression adjusted for repeated measures (Stata, version 13.1, StataCorp, TX, USA). GraphPad Prism (version 6.00 for Windows, GraphPad Software, La Jolla California, USA) will be used to plot the data. Data (day frequency, night frequency, urgency and incontinence) will be evaluated by intention to treat analysis, with the last result brought forward for people who dropped out or were lost to follow-up. Variables selected for adjustment using backward stepwise regression from list including age, sex, water intake and diuretic use (p\\<0.22 for covariate inclusion). Holm estimation test will be used to adjust p-values for repeated measures. Each analysis will only included participants who are symptomatic at baseline. For example, in relation to daytime urinary frequency - only participants with baseline of ≥10 will be included in the analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria include symptoms of urinary frequency (at least ten times per day) and/or incontinence (at least nine episodes per week), provided they have experienced symptoms of OAB for at least 6 months.\n\nExclusion Criteria:\n\n1. Recent surgery particularly hysterectomy or prolapse repair (within the last 12 months)\n2. Recently undergone childbirth (within the last 12 months), or currently pregnant.\n3. Use of any natural therapies for bladder symptoms in the last month.\n4. Concomitant health conditions such as uncontrolled diabetes mellitus, heart disease, pancreatic, hepatic or renal disease, recurrent urinary tract infections, and chronic inflammatory conditions, which may otherwise affect outcomes.\n5. Currently being treated for mental health issues or psychiatric disturbances.\n6. Any individuals who are presently taking prescribed medication for incontinence or OAB.'}, 'identificationModule': {'nctId': 'NCT02396160', 'briefTitle': 'The Effect of Urox™ in the Treatment of Overactive Bladder and Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'The University of Queensland'}, 'officialTitle': 'The Effect of Urox™(Crateva, Horsetail and Lindera Combination) in the Treatment of Overactive Bladder and Urinary Incontinence', 'orgStudyIdInfo': {'id': 'SG-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': '2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root', 'interventionNames': ['Dietary Supplement: Urox']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'identical placebo vegetarian capsule containing color-matched cellulose', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Urox', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Niikee Schoendorfer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As data was analysed de-identified, it is not possible to have individual participant data available associated with their name and details.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Queensland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tasmania', 'class': 'OTHER'}, {'name': 'Seipel Group Pty Ltd', 'class': 'INDUSTRY'}, {'name': 'Endeavour College of Natural Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Dr Niikee Schoendorfer', 'investigatorAffiliation': 'The University of Queensland'}}}}