Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-26 @ 10:04 PM
Study NCT ID:
NCT01938092
Status:
COMPLETED
Last Update Posted:
2024-09-03
First Post:
2013-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaginal Diazepam for the Treatment of Female Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059952', 'term': 'Pelvic Floor Disorders'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D013035', 'term': 'Spasm'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003975', 'term': 'Diazepam'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drobnise@health.missouri.edu', 'phone': '573-817-3124', 'title': 'Erma Z. Drobnis, Associate Director, Research Success Center', 'organization': 'University of Missouri-Columibia, Dept. Ob/Gyn'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '1. 92% of participants Caucasian; results may differ in diverse populations\n2. participants in placebo group more likely to use vaginal estrogen\n3. Powered to detect a 20% difference if present; underpowered to detect a smaller difference.'}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Diazepam', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nDiazepam', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nPlacebo', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diazepam', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nDiazepam'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '75'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '55'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': "Ten centimeter (100 mm) linear pain scale where patients mark their self-perceived level of pain on a paper with a 10 cm line indicating that the 0 cm position indicates no pain and the 10 cm position indicates the worst pain imaginable. The score is measured as the distance between the zero position and the patient's mark is measured in cm to the nearest mm. A higher score indicates a worse outcome.\n\nThe change in pain score is calculated by from the value at baseline minus the value at 4 weeks. Potential range is -100 to 100, with a higher value indicating a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for visual analog score (VAS) for pain. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided VAS data for pain. Data from the latter group of 35 patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diazepam', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nDiazepam'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '116'}, {'value': '107', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '164'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'The Pelvic Floor Distress Inventory-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. Includes 20 questions and 3 scales. Each of the 3 scales is scored from a minimum score of 0 (least distress) to a maximum of 100 (greatest distress), thus a higher score indicates a poorer outcome. The scores from each of the 3 scales are added together to give a summary score (range 0 to 300). The PFDI-20 questionnaire was administered at baseline and at 4 weeks of treatment. The outcome was the score at 4 weeks of treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for the pelvic floor distress inventory-20 (PFDI-20) questionnaire. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided PFDI-20 questionnaire data. Data from the latter group of 35 patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'McGill Pain Questionnaire Score (PRI) at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diazepam', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nDiazepam'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '38'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '41'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'The McGilll pain questionnaire is a validated instrument that assigns quantitative value to qualitative descriptions of chosen by the patient. The minimum pain score is 0 (would not be seen in a person with true pain) and the maximum pain score: 78. The higher the pain score the greater the pain and the poorer the outcome. measured at 4 weeks.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'After randomization, 25 patients on diazepam treatment and 24 patients on placebo provided baseline values for the McGill pain questionnaire. At 4 weeks treatment, 19 patients in the diazepam group and 16 patients in the placebo group provided McGill pain questionnaire data. Data from the latter group of 35 patients were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diazepam', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nDiazepam'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'urogynecology outpatient clinic patients sequentially enrolled September 2013-August 2016. Inclusion: 18+ years of age with primary complaint of acute or chronic pelvic pain, with or without dyspareunia, and hypertonicity of the levator muscles. Exclusion: pregnant, breastfeeding, previous pelvic floor therapy, contraindication to denzodiazepines'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Diazepam', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nDiazepam'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '58'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '53.5'}, {'value': '42', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '54.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.07', 'groupId': 'BG000', 'lowerLimit': '23.79', 'upperLimit': '30.32'}, {'value': '26.99', 'groupId': 'BG001', 'lowerLimit': '24.26', 'upperLimit': '37.95'}, {'value': '27.07', 'groupId': 'BG002', 'lowerLimit': '24.14', 'upperLimit': '33.52'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gravida', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4.5'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of pregnancies', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Term Pregnancies', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0.25', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of full-term pregnancies', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Cesarean sections', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of cesarean sections', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Vaginal deliveries', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of vaginal deliveries', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Largest baby', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3713', 'groupId': 'BG000', 'lowerLimit': '3203', 'upperLimit': '4082'}, {'value': '3487', 'groupId': 'BG001', 'lowerLimit': '2821', 'upperLimit': '4068'}, {'value': '3642', 'groupId': 'BG002', 'lowerLimit': '2934', 'upperLimit': '4082'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'gm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Symptom duration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '72'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '120'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Post void residual', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '50'}, {'value': '35', 'groupId': 'BG001', 'lowerLimit': '11.25', 'upperLimit': '90'}, {'value': '25', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Prolapse', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Prolapse data unavailable for 1 diazepam and 2 placebo participants'}, {'title': 'diabetes mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiovascular disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lung disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low back pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gastrointestinal disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Headache', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neurological disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anxiety', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Depression', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bipolar disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Obsterical trauma', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menopausal', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current hormone replacement therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal estrogen use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hysterectomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mesh surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heavy lifting', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-18', 'size': 280852, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-14T17:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2013-08-30', 'resultsFirstSubmitDate': '2018-07-25', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-29', 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) for Pain', 'timeFrame': 'Baseline and 4 weeks', 'description': "Ten centimeter (100 mm) linear pain scale where patients mark their self-perceived level of pain on a paper with a 10 cm line indicating that the 0 cm position indicates no pain and the 10 cm position indicates the worst pain imaginable. The score is measured as the distance between the zero position and the patient's mark is measured in cm to the nearest mm. A higher score indicates a worse outcome.\n\nThe change in pain score is calculated by from the value at baseline minus the value at 4 weeks. Potential range is -100 to 100, with a higher value indicating a better outcome."}], 'secondaryOutcomes': [{'measure': 'Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks.', 'timeFrame': '4 weeks', 'description': 'The Pelvic Floor Distress Inventory-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. Includes 20 questions and 3 scales. Each of the 3 scales is scored from a minimum score of 0 (least distress) to a maximum of 100 (greatest distress), thus a higher score indicates a poorer outcome. The scores from each of the 3 scales are added together to give a summary score (range 0 to 300). The PFDI-20 questionnaire was administered at baseline and at 4 weeks of treatment. The outcome was the score at 4 weeks of treatment.'}, {'measure': 'McGill Pain Questionnaire Score (PRI) at 4 Weeks', 'timeFrame': '4 weeks', 'description': 'The McGilll pain questionnaire is a validated instrument that assigns quantitative value to qualitative descriptions of chosen by the patient. The minimum pain score is 0 (would not be seen in a person with true pain) and the maximum pain score: 78. The higher the pain score the greater the pain and the poorer the outcome. measured at 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High-tone pelvic floor dysfunction', 'Spasm', 'Pelvic pain', 'Diazepam', 'Female', 'Randomized trial'], 'conditions': ['Pelvic Floor Disorders', 'Pelvic Pain']}, 'referencesModule': {'references': [{'pmid': '29280763', 'type': 'DERIVED', 'citation': 'Holland MA, Joyce JS, Brennaman LM, Drobnis EZ, Starr JA, Foster RT Sr. Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2019 Jan/Feb;25(1):76-81. doi: 10.1097/SPV.0000000000000514.'}]}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.', 'detailedDescription': 'Women who are asked to participate will already be receiving a standard conservative therapy consisting of a psyllium-based bowel regimen, heat therapy, pelvic stretching exercises, and Kegel exercises. Participants will randomly be assigned by a computer-derived random number sequence (after pregnancy is ruled out) to either the treatment group (intravaginal diazepam) or the placebo group Investigators and patients will be blinded to group assignment. The placebo or diazepam tablet will be distributed to the participant in the examining room on the day of allocation. The participant will be instructed to insert the diazepam or placebo tablet into her vagina at home. The treatment group will insert the diazepam 10 mg vaginal tablet 1-2 times daily as needed in addition to the standard conservative therapy. The placebo group will receive the standard conservative therapy, and an intravaginal tablet (visually indistinguishable from diazepam) commercially produced by the university pharmacy. After 4 weeks, patients from either group will have the option of enrolling into a standard routine program (not research) of comprehensive pelvic floor rehabilitation therapy. The Visual Analog Pain Scale, Pelvic Floor Distress Inventory-20 Questionnaire, McGill Pain Questionnaire and Global Response Assessment will be completed by the participant at the initial visit, 4 weeks, 8 weeks and 12 weeks. Participants will be given the option of choosing one or more methods for returning questionnaires: electronic mail, self-addressed home envelope, or telephone call.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years old\n* Primary complaint of acute or chronic pelvic pain with or without dyspareunia\n* Physical exam findings consistent with levator muscle spasm\n* Capable of inserting tablet in vagina without use of applicator.\n\nExclusion Criteria:\n\n* Chronic narcotic use\n* Non-English speaking\n* Currently serving a prison sentence\n* Stage III or greater vaginal prolapse\n* Allergies or contraindications to benzodiazepines\n* Pregnant or breastfeeding\n* Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal valium therapy\n* Unwilling or incapable of inserting tablet in vagina without applicator.'}, 'identificationModule': {'nctId': 'NCT01938092', 'briefTitle': 'Vaginal Diazepam for the Treatment of Female Pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '1208827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diazepam', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.', 'interventionNames': ['Drug: Diazepam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participated will be instructed to insert one 10mg tablet vaginally 1-2 times per day as needed for pain.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Diazepam', 'type': 'DRUG', 'otherNames': ['Valium'], 'armGroupLabels': ['Diazepam']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Center for Female Continence and Advanced Pelvic Surgery, University of Missouri Health System', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Raymond T Foster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raymond Foster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Raymond Foster', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}