Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-26 @ 10:23 AM
Study NCT ID:
NCT01167257
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2010-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
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': 'hck@tzuchi.com.tw', 'phone': '886-3-8561825', 'title': 'Dr. Hann-Chorng Kuo', 'phoneExt': '2113', 'organization': 'Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Arm', 'description': "Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A'\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day", 'otherNumAtRisk': 31, 'otherNumAffected': 10, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Arm', 'description': "Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation'\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation", 'otherNumAtRisk': 31, 'otherNumAffected': 16, 'seriousNumAtRisk': 31, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Cervical spondylosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body in conjunctival SAC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unspecified otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness and giddiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal fullness pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection upper tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Couch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unspecified local infections of skin and subcutaneous tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture of ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Traumatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture of clavicle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'notes': 'Contusion of face, scalp, neck except eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Functional disorder of stomach disturbance irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatophytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Knee osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'C-spine whiplash injury with radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change of the Total Frequency Per 3 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.64', 'groupId': 'OG000', 'lowerLimit': '-7.46', 'upperLimit': '-1.82'}, {'value': '-0.19', 'groupId': 'OG001', 'lowerLimit': '-2.98', 'upperLimit': '2.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:\n\nMean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.\n\nChange = Week 4 minus Baseline value', 'unitOfMeasure': 'Frequency per 3 days', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects'}, {'type': 'SECONDARY', 'title': 'Mean Change of the Urgency Episodes Per 3 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.43', 'groupId': 'OG000', 'lowerLimit': '-11.68', 'upperLimit': '-3.18'}, {'value': '-3.43', 'groupId': 'OG001', 'lowerLimit': '-7.30', 'upperLimit': '0.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:\n\nMean change of the Urgency episodes per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.\n\nChange = Week 4 minus Baseline value', 'unitOfMeasure': 'Frequency per 3 days', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects'}, {'type': 'SECONDARY', 'title': 'Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '-3.33', 'upperLimit': '4.19'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '-1.27', 'upperLimit': '2.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:\n\nMean change of the urgency urinary incontinence (UUI) per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.\n\nChange = Week 4 minus Baseline value', 'unitOfMeasure': 'Frequency per 3 days', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects'}, {'type': 'SECONDARY', 'title': 'Net Change of the Overactive Bladder Symptom Score (OABSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10ml in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.86', 'groupId': 'OG000', 'lowerLimit': '-2.96', 'upperLimit': '-0.76'}, {'value': '-0.75', 'groupId': 'OG001', 'lowerLimit': '-2.01', 'upperLimit': '0.51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline to 1 month) Overactive bladder symptom score (OABSS) The OABSS is a 4-item questionnaire developed to evaluate OAB symptoms. The maximal scores are 2, 3, 5 and 5 for daytime frequency, nighttime frequency, urgency and urgency in continence, respectively.\n\nThe OABSS range = 0 to 15 ((asymptomatic to very symptomatic). Change = Week 4 minus Baseline value', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range'}, {'type': 'SECONDARY', 'title': 'Net Change of the Functional Bladder Capacity (FBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.86', 'groupId': 'OG000', 'lowerLimit': '-45.79', 'upperLimit': '20.08'}, {'value': '18.15', 'groupId': 'OG001', 'lowerLimit': '-16.37', 'upperLimit': '52.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Functional bladder capacity (FBC) Change = Week 4 minus Baseline value', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'populationDescription': 'Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects'}, {'type': 'SECONDARY', 'title': 'Net Change of the Maximum Flow Rate (Qmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 Ll water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '-2.02', 'upperLimit': '2.25'}, {'value': '-0.84', 'groupId': 'OG001', 'lowerLimit': '-4.30', 'upperLimit': '2.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Maximum flow rate (Qmax) Change = Week 4 minus Baseline value', 'unitOfMeasure': 'mL/s', 'dispersionType': 'Inter-Quartile Range', 'populationDescription': 'Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects'}, {'type': 'SECONDARY', 'title': 'Net Change of the Postvoid Residual Volume (PVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.65', 'groupId': 'OG000', 'lowerLimit': '-20.13', 'upperLimit': '14.84'}, {'value': '-2.31', 'groupId': 'OG001', 'lowerLimit': '-19.43', 'upperLimit': '14.81'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 1 month after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Postvoid residual volume (PVR) Change = Week 4 minus Baseline value', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range'}, {'type': 'SECONDARY', 'title': 'Net Change of the Urgency Severity Score (USS) Within 3 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Worsen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Urgency severity score (USS) within 3 days. The USS have 1-point scale ranging from 0 to 4. The USS grades urgency per toilet void as none, mild, moderate or severe.', 'unitOfMeasure': 'participants'}, {'type': 'SECONDARY', 'title': 'Net Change of the Global Response Assessment (GRA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) The Global response assessment (GRA) have seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.', 'unitOfMeasure': 'participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Normal saline 50ml in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Arm', 'description': 'Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80mg/40ml) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.43', 'spread': '12.49', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '82'}, {'value': '65.81', 'spread': '14.48', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '73'}, {'value': '65.12', 'spread': '13.49', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Associated medical conditions', 'classes': [{'title': 'Diabetes Mellitus', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Pelvic surgery', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Non disease', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Background or Prior disease', 'classes': [{'title': 'Any prior disease', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior therapy', 'classes': [{'title': 'Prior therapy taken', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-19', 'studyFirstSubmitDate': '2010-07-20', 'resultsFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-19', 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change of the Total Frequency Per 3 Days', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:\n\nMean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.\n\nChange = Week 4 minus Baseline value'}], 'secondaryOutcomes': [{'measure': 'Mean Change of the Urgency Episodes Per 3 Days', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:\n\nMean change of the Urgency episodes per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.\n\nChange = Week 4 minus Baseline value'}, {'measure': 'Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:\n\nMean change of the urgency urinary incontinence (UUI) per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.\n\nChange = Week 4 minus Baseline value'}, {'measure': 'Net Change of the Overactive Bladder Symptom Score (OABSS)', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline to 1 month) Overactive bladder symptom score (OABSS) The OABSS is a 4-item questionnaire developed to evaluate OAB symptoms. The maximal scores are 2, 3, 5 and 5 for daytime frequency, nighttime frequency, urgency and urgency in continence, respectively.\n\nThe OABSS range = 0 to 15 ((asymptomatic to very symptomatic). Change = Week 4 minus Baseline value'}, {'measure': 'Net Change of the Functional Bladder Capacity (FBC)', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Functional bladder capacity (FBC) Change = Week 4 minus Baseline value'}, {'measure': 'Net Change of the Maximum Flow Rate (Qmax)', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Maximum flow rate (Qmax) Change = Week 4 minus Baseline value'}, {'measure': 'Net Change of the Postvoid Residual Volume (PVR)', 'timeFrame': 'Baseline and 1 month after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Postvoid residual volume (PVR) Change = Week 4 minus Baseline value'}, {'measure': 'Net Change of the Urgency Severity Score (USS) Within 3 Days', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) Urgency severity score (USS) within 3 days. The USS have 1-point scale ranging from 0 to 4. The USS grades urgency per toilet void as none, mild, moderate or severe.'}, {'measure': 'Net Change of the Global Response Assessment (GRA)', 'timeFrame': 'Baseline to 4 weeks after initial treatment', 'description': 'Efficacy:(measured the net change of variables from baseline and 1 month) The Global response assessment (GRA) have seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overactive bladder', 'Detrusor overactivity', 'Liposome', 'Botulinum toxin A'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided needle injection for refractory OAB.', 'detailedDescription': 'Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urgency incontinence, usually no metabolic or anatomical disorders can be found and it may have great impact on quality of life. Traditional medication for OAB is antimuscarinic agent which targets at the muscarinic receptors. There are several adverse events such as dry mouth, constipation, blurred vision, and dizziness related to antimuscarinics, therefore, some patients cannot tolerated this treatment. Intravesical botulinum toxin A (BoNT-A) has recently emerged as novel treatment for OAB refractory to antimuscarinics, however, BoNT-A injection can cause acute urinary retention and large postvoid residual. Urinary tract infection usually occurred following large postvoid residual and urinary retention. If we can deliver BoNT-A through the urothelium to the suburothelial space, but not into the detrusor layer, we might have therapeutic effects on the urothelial sensory nerves without compromising the detrusor contractility. This treatment will enable us to prevent the undesired detrusor underactivity after BoNT-A injection, especially in the elderly patients who had impaired detrusor contractility and OAB. Liposomes are vesicles, composed of concentric phospholipid bilayers separated by aqueous compartments. Because liposomes adsorb to cell surfaces and fuse with cells, they are being used as vehicles for drug delivery and gene therapy. In this grant we will evaluate liquid liposome delivery of BoNT-A (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided needle injection for refractory OAB, and study the mechanism of action of intravesical liposomal drug delivery. If successful, we will leverage our technology transfer expertise and bring the science from the bench top to the bed side to apply for a physician sponsored Investigational New Drug (IND) trial using liposome-BoNT in patients with OAB or DO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults with age of 20 years old or above\n2. Patients with symptoms of urgency frequency and/or urge incontinence and a urgency severity scale (USS) of at least 2, with or without urodynamically proven detrusor overactivity (DO) (defined by the International Continence Society (ICS) recommendation as: spontaneous detrusor contraction occurring during bladder filling phase or occurring before uninhibited detrusor contraction voiding at bladder capacity in the urodynamic study)\n3. Free of active urinary tract infection\n4. Free of bladder outlet obstruction on enrollment\n5. Free of overt neurogenic bladder dysfunction\n6. Having been treated with antimuscarinic agents for at least 4 weeks without effect or with intolerable adverse effects\n7. Patient has not been treated with bladder surgery for OAB, such as enterocystoplasty, that might affect the therapeutic effect of test drug\n8. Patient can record voiding diary for the urinary frequency and urgency\n9. Patient or his/her legally acceptable representative has signed the written informed consent form\n\nExclusion Criteria:\n\n1. Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms\n2. Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up\n3. Patients with bladder outlet obstruction on enrollment\n4. Patients with postvoid residual \\>150 mL\n5. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection\n6. Patients have laboratory abnormalities at screening including:\n\n Alanine aminotransferase (ALT) \\>3 x upper limit of normal range Aspartate aminotransferase (AST) \\>3 x upper limit of normal range Patients have abnormal serum creatinine level \\>2 x upper limit of normal range\n7. Patients with any contraindication to be urethral catheterization during treatment\n8. Female patients who is pregnant, lactating, or with child-bearing potential without contraception.\n9. Myasthenia gravis, Eaton Lambert syndrome.\n10. Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial\n11. Patients participated investigational drug trial within 1 month before entering this study'}, 'identificationModule': {'nctId': 'NCT01167257', 'briefTitle': 'Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': 'Comparative Study of the Efficacy and Safety of Liposome Encapsulated Botulinum Toxin-A (Lipotoxin) Versus Normal Saline Instillation in Treatment of Patients With Refractory Overactive Bladder Syndrome', 'orgStudyIdInfo': {'id': 'TCGHUROL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': "Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation\n\nLiposome encapsulated botulinum toxin A'", 'interventionNames': ['Drug: Liposome encapsulated botulinum toxin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': "Normal saline 50 mL in single intravesical instillation\n\nNormal saline instillation'", 'interventionNames': ['Drug: Normal saline instillation']}], 'interventions': [{'name': 'Liposome encapsulated botulinum toxin A', 'type': 'DRUG', 'otherNames': ['Lipotoxin'], 'description': 'Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day', 'armGroupLabels': ['Experimental arm']}, {'name': 'Normal saline instillation', 'type': 'DRUG', 'otherNames': ['N/S'], 'description': 'Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Buddhist Tzu Chi General Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'overallOfficials': [{'name': 'Hann-Chorng Kuo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University'}, {'name': 'Yao-Chi Chuang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Urology', 'investigatorFullName': 'Hann-Chorng Kuo', 'investigatorAffiliation': 'Buddhist Tzu Chi General Hospital'}}}}