Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT02995967
Status:
TERMINATED
Last Update Posted:
2019-03-13
First Post:
2016-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmalek@uabmc.edu', 'phone': '2059965466', 'title': 'Joseph Malek', 'organization': 'UAB'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptom Bother', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '12 weeks', 'description': 'The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Urge Urinary Incontinence Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '12 weeks', 'description': 'Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Total Number of Voids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Just the intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '12 weeks', 'description': 'Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Subjects Requiring Clean Intermittent Self-catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '2 weeks', 'description': 'Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of \\> 300 mL or \\> 150 mL in the presence of bothersome retention symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Post Void Residual Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '2 weeks', 'description': 'Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Rate of UTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '2 weeks', 'description': 'Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Quality of Life Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '12 weeks', 'description': 'Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Patient Impression of Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '12 weeks', 'description': 'Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '12 weeks', 'description': 'Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}, {'type': 'SECONDARY', 'title': 'Quality of Life Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'OG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'timeFrame': '24 weeks', 'description': 'Subjective outcome at 24 weeks using the OAB-q', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis done due to study being stopped for poor enrollment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'FG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Although 3 participants completed the study, no analysis done due to study being stopped for poor enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin A Alone Group', 'description': 'Intradetrusor injection of 100 units of botulinum toxin A alone\n\nBotulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a'}, {'id': 'BG001', 'title': 'Hydrodistention Group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A\n\nHydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'age over 50 yrs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'age uner 50 yrs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or AlaskaNative', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-09', 'size': 291731, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-14T18:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-15', 'studyFirstSubmitDate': '2016-12-09', 'resultsFirstSubmitDate': '2018-06-23', 'studyFirstSubmitQcDate': '2016-12-14', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-19', 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Bother', 'timeFrame': '12 weeks', 'description': 'The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.'}], 'secondaryOutcomes': [{'measure': 'Urge Urinary Incontinence Episodes', 'timeFrame': '12 weeks', 'description': 'Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.'}, {'measure': 'Total Number of Voids', 'timeFrame': '12 weeks', 'description': 'Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.'}, {'measure': 'Subjects Requiring Clean Intermittent Self-catheterization', 'timeFrame': '2 weeks', 'description': 'Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of \\> 300 mL or \\> 150 mL in the presence of bothersome retention symptoms.'}, {'measure': 'Post Void Residual Volume', 'timeFrame': '2 weeks', 'description': 'Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.'}, {'measure': 'Rate of UTI', 'timeFrame': '2 weeks', 'description': 'Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.'}, {'measure': 'Quality of Life Measures', 'timeFrame': '12 weeks', 'description': 'Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.'}, {'measure': 'Patient Impression of Improvement', 'timeFrame': '12 weeks', 'description': 'Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).'}, {'measure': 'Patient Satisfaction', 'timeFrame': '12 weeks', 'description': 'Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).'}, {'measure': 'Quality of Life Measures', 'timeFrame': '24 weeks', 'description': 'Subjective outcome at 24 weeks using the OAB-q'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin A has additional benefit in patients with refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection of botulinum toxin A alone.\n\nConsented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone (botulinum toxin A alone group).\n\nThe primary aim will be subjective improvement measured as change from baseline at 12 weeks using the OAB-q bother subscale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with refractory overactive bladder symptoms, failing a credible behavioral therapy intervention and medical therapy or not tolerating medical therapy. Patients who are on medical therapy will stop the medical therapy for at least 2 weeks prior to botulinum toxin A treatment in the study\n* Female ≥ 18 years old\n* Desires further treatment for OAB symptoms.\n* Express understanding and ability to perform clean intermittent self-catheterization (CISC) if required.\n* Ability to consent\n* Ability to complete all study related items and interviews\n\nExclusion Criteria:\n\n* Post void residual urine volume \\> 150 mL as assessed by catheter or ultrasound\n* History of intradetrusor botulinum toxin A injection\n* History of or current cancer of the genitourinary or gynecology tract\n* Neurogenic bladder\n* Interstitial cystitis\n* Current urinary tract infection (can be treated and re-considered for study)\n* Current active sacral neuromodulation device\n* Non-English speaking\n* History of chronic pelvic pain\n* Hematuria not previously evaluated'}, 'identificationModule': {'nctId': 'NCT02995967', 'acronym': 'HydrA', 'briefTitle': 'Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder', 'orgStudyIdInfo': {'id': 'F160629005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum toxin A alone group', 'description': 'Just the intradetrusor injection of 100 units of botulinum toxin A alone', 'interventionNames': ['Drug: Botulinum toxin-A']}, {'type': 'EXPERIMENTAL', 'label': 'Hydrodistention group', 'description': 'Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A', 'interventionNames': ['Procedure: Hydrodistention']}], 'interventions': [{'name': 'Hydrodistention', 'type': 'PROCEDURE', 'description': 'The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.', 'armGroupLabels': ['Hydrodistention group']}, {'name': 'Botulinum toxin-A', 'type': 'DRUG', 'description': 'Intradetrusor injection of 100 units of botulinum toxin a', 'armGroupLabels': ['Botulinum toxin A alone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joseph Malek', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}