Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-01-23 @ 2:10 AM
Study NCT ID:
NCT03057834
Status:
COMPLETED
Last Update Posted:
2025-11-07
First Post:
2017-02-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Urinary Incontinence Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'candace.parkerautry@wfusm.edu', 'phone': '336-716-3779', 'title': 'Candace Parker-Autry, MD', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Collected from baseline through week 12', 'eventGroups': [{'id': 'EG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Urinary Incontinence Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'OG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Using a three-day voiding diary', 'unitOfMeasure': 'number of incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Urinary Incontinence Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'OG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 6', 'description': 'Using a three-day voiding diary', 'unitOfMeasure': 'number of incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Urinary Incontinence Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'OG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 12', 'description': 'Using a three-day voiding diary', 'unitOfMeasure': 'number of incontinence episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Power of Contractions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'OG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '29.3', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 12', 'description': 'measurement of strength using perineometer', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Endurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'OG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 12', 'description': 'measure of how long they can hold contraction', 'unitOfMeasure': 'time in seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Repetition of Contractions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'OG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 12', 'description': 'how many repetitions can they sustain', 'unitOfMeasure': 'number of repetitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Fast Contractions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'OG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 12', 'description': 'number of fast contractions that can be repeated', 'unitOfMeasure': 'number of fast contractions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pelvic Organ Prolapse', 'timeFrame': 'baseline, week 12', 'description': 'measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Short Physical Performance Battery (expSPPB)--Gait Speed', 'timeFrame': 'week 12', 'description': 'expSPPB scores range from zero to 12 possible points. SPPB score of 0 indicates the lowest physical performance, and a score of 12 indicates the highest performance', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '400 Meter Walk', 'timeFrame': 'week 12', 'description': 'measurement of exercise tolerance', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Isokinetic Dynamometer', 'timeFrame': 'week 12', 'description': 'maximal isokinetic knee extensor strength in the right leg will be measured at speeds of 60 degrees/sec. The left leg will be used if there is a reason not to measure the right leg.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postural Sway', 'timeFrame': 'week 12', 'description': 'Center-of-Pressure (COP) trajectory data will be collected using an Advanced Mechanical Incorporated (AMTI) AccuSway biomechanics force platform. Participants will be barefoot in an upright stance with arms raised comfortably at their sides, feet abducted, and heels separated. Four posturographic parameters (maximum antero-posterior and medio-lateral displacement, average sway velocity, and 95% confidence ellipse) and two statistical mechanics measures (stabilogram diffusion analysis and detrended fluctuation analysis) will be calculated to quantify postural sway according to our previously published methods.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Grip Strength', 'timeFrame': 'week 12', 'description': 'measure of weakness', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gait Speed', 'timeFrame': 'week 12', 'description': 'Determined based on 4-meter walk at usual speed', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Questionnaire', 'timeFrame': 'week 12', 'description': 'The SARC-F questionnaire is validated to identify adults with sarcopenia and who are at risk for adverse outcomes and may benefit from a physical function intervention. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Appendicular Lean Muscle Mass/Height', 'timeFrame': 'week 12', 'description': 'calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire', 'timeFrame': 'week 12', 'description': "a brief valid measure that assesses weekly frequency and duration of various physical activities common to older adults to evaluate the efficacy of behavioral interventions to increase levels of physical activity. Caloric expenditure (MET hours/week) will be reported.\\[8\\] 'Low activity' will be defined as \\<6.2 MET-hours/week of activity. Women with MET hr/week between 6.3 and 11.4 will be classified as low-moderate activity. Since only 23% of incontinent women had \\>11.4 MET hours/week of physical activity, this level will be defined as high activity.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Barriers to Physical Activity Questionnaire', 'timeFrame': 'week 12', 'description': 'Questions regarding attitudes towards physical activity considering UI symptoms and perceived barriers will be assessed. 21-item measure assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63 with a higher score indicating a higher amount of perceived barriers.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mobility Assessment Tool-Short Form (MAT-SF) Score', 'timeFrame': 'week 12', 'description': 'This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Abdominal Circumference', 'timeFrame': 'week 12', 'description': 'measure of abdominal circumference will be obtained to determine obesity severity', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Global Impression of Improvement (PGI)', 'timeFrame': 'week 12', 'description': 'The PGI is a single-item, 7-point scale used to assess a patient\'s overall perception of their condition\'s change after treatment. Originating from the Clinical Global Impression-Improvement (CGI-I) scale used by clinicians, the PGI-I allows patients to rate their progress from "Very Much Improved" to "Very Much Worse," providing a simple, validated, and patient-centered outcome measure for various medical and psychiatric conditions. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction Question', 'timeFrame': 'week 12', 'description': 'Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Estimated Perception of Improvement Question', 'timeFrame': 'week 12', 'description': 'Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'week 12', 'description': 'MoCA score ranges from 0 to 30 and is used as a screening tool for mild cognitive impairment. A score of 26 or over is considered to be normal.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'FG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Week 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Week 12', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Functionally Impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'BG001', 'title': 'Functionally Normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10\n\nPelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.9', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '76', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '76.9', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '70', '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': [{'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': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '30.53', 'spread': '3.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weight (kg) / Height (m)^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-05', 'size': 3032870, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-09T16:02', 'hasProtocol': True}, {'date': '2019-09-18', 'size': 214785, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-17T10:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be determined based on the score on the SPPB.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2017-02-10', 'resultsFirstSubmitDate': '2025-10-09', 'studyFirstSubmitQcDate': '2017-02-17', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-24', 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pelvic Organ Prolapse', 'timeFrame': 'baseline, week 12', 'description': 'measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system'}, {'measure': 'Short Physical Performance Battery (expSPPB)--Gait Speed', 'timeFrame': 'week 12', 'description': 'expSPPB scores range from zero to 12 possible points. SPPB score of 0 indicates the lowest physical performance, and a score of 12 indicates the highest performance'}, {'measure': '400 Meter Walk', 'timeFrame': 'week 12', 'description': 'measurement of exercise tolerance'}, {'measure': 'Isokinetic Dynamometer', 'timeFrame': 'week 12', 'description': 'maximal isokinetic knee extensor strength in the right leg will be measured at speeds of 60 degrees/sec. The left leg will be used if there is a reason not to measure the right leg.'}, {'measure': 'Postural Sway', 'timeFrame': 'week 12', 'description': 'Center-of-Pressure (COP) trajectory data will be collected using an Advanced Mechanical Incorporated (AMTI) AccuSway biomechanics force platform. Participants will be barefoot in an upright stance with arms raised comfortably at their sides, feet abducted, and heels separated. Four posturographic parameters (maximum antero-posterior and medio-lateral displacement, average sway velocity, and 95% confidence ellipse) and two statistical mechanics measures (stabilogram diffusion analysis and detrended fluctuation analysis) will be calculated to quantify postural sway according to our previously published methods.'}, {'measure': 'Grip Strength', 'timeFrame': 'week 12', 'description': 'measure of weakness'}, {'measure': 'Gait Speed', 'timeFrame': 'week 12', 'description': 'Determined based on 4-meter walk at usual speed'}, {'measure': 'Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Questionnaire', 'timeFrame': 'week 12', 'description': 'The SARC-F questionnaire is validated to identify adults with sarcopenia and who are at risk for adverse outcomes and may benefit from a physical function intervention. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.'}, {'measure': 'Appendicular Lean Muscle Mass/Height', 'timeFrame': 'week 12', 'description': 'calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit'}, {'measure': 'Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire', 'timeFrame': 'week 12', 'description': "a brief valid measure that assesses weekly frequency and duration of various physical activities common to older adults to evaluate the efficacy of behavioral interventions to increase levels of physical activity. Caloric expenditure (MET hours/week) will be reported.\\[8\\] 'Low activity' will be defined as \\<6.2 MET-hours/week of activity. Women with MET hr/week between 6.3 and 11.4 will be classified as low-moderate activity. Since only 23% of incontinent women had \\>11.4 MET hours/week of physical activity, this level will be defined as high activity."}, {'measure': 'Barriers to Physical Activity Questionnaire', 'timeFrame': 'week 12', 'description': 'Questions regarding attitudes towards physical activity considering UI symptoms and perceived barriers will be assessed. 21-item measure assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63 with a higher score indicating a higher amount of perceived barriers.'}, {'measure': 'Mobility Assessment Tool-Short Form (MAT-SF) Score', 'timeFrame': 'week 12', 'description': 'This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility.'}, {'measure': 'Abdominal Circumference', 'timeFrame': 'week 12', 'description': 'measure of abdominal circumference will be obtained to determine obesity severity'}, {'measure': 'Patient Global Impression of Improvement (PGI)', 'timeFrame': 'week 12', 'description': 'The PGI is a single-item, 7-point scale used to assess a patient\'s overall perception of their condition\'s change after treatment. Originating from the Clinical Global Impression-Improvement (CGI-I) scale used by clinicians, the PGI-I allows patients to rate their progress from "Very Much Improved" to "Very Much Worse," providing a simple, validated, and patient-centered outcome measure for various medical and psychiatric conditions. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse).'}, {'measure': 'Patient Satisfaction Question', 'timeFrame': 'week 12', 'description': 'Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all)'}, {'measure': 'Estimated Perception of Improvement Question', 'timeFrame': 'week 12', 'description': 'Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better).'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'week 12', 'description': 'MoCA score ranges from 0 to 30 and is used as a screening tool for mild cognitive impairment. A score of 26 or over is considered to be normal.'}], 'primaryOutcomes': [{'measure': 'Number of Urinary Incontinence Episodes', 'timeFrame': 'Baseline', 'description': 'Using a three-day voiding diary'}, {'measure': 'Number of Urinary Incontinence Episodes', 'timeFrame': 'week 6', 'description': 'Using a three-day voiding diary'}, {'measure': 'Number of Urinary Incontinence Episodes', 'timeFrame': 'week 12', 'description': 'Using a three-day voiding diary'}], 'secondaryOutcomes': [{'measure': 'Power of Contractions', 'timeFrame': 'week 12', 'description': 'measurement of strength using perineometer'}, {'measure': 'Endurance', 'timeFrame': 'week 12', 'description': 'measure of how long they can hold contraction'}, {'measure': 'Repetition of Contractions', 'timeFrame': 'week 12', 'description': 'how many repetitions can they sustain'}, {'measure': 'Number of Fast Contractions', 'timeFrame': 'week 12', 'description': 'number of fast contractions that can be repeated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '35852275', 'type': 'DERIVED', 'citation': 'Parker-Autry C, Neiberg R, Leng XI, Matthews CA, Dumoulin C, Kuchel G, Kritchevsky SB. Examining the Role of Nonsurgical Therapy in the Treatment of Geriatric Urinary Incontinence. Obstet Gynecol. 2022 Aug 1;140(2):243-251. doi: 10.1097/AOG.0000000000004852. Epub 2022 Jul 6.'}]}, 'descriptionModule': {'briefSummary': "Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If investigators find unequal numbers, they will adapt recruit strategies based on a woman's functional status.", 'detailedDescription': "Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If they find unequal numbers, they will adapt recruit strategies based on a woman's functional status.\n\nInvestigators will compare changes in outcome measures within and between groups after 6 and 12 weeks of pelvic floor muscle exercises (PFME). The change in pelvic floor strength/efficiency will be assessed by repeating the pelvic floor PERFECT assessment and will be compared between groups. Changes in UI symptoms, symptom severity, and impact of UI symptoms on quality of life will be determined using standardized measures described above. Data analysis will define associations between changes in PERFECT measures and the change in UI episodes (based on 3-day voiding diary), severity, and type (based on QUID-7), and impact on quality of life (PFIQ-7) within and between groups. Objective measurement of lower-extremity strength will inform the relationship between lower-extremity strength, pelvic floor strength, and UI symptoms at baseline and the 6-week visit."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'genderBased': True, 'genderDescription': 'Must be born a woman due to the nature of the intervention investigators are studying.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women, age 70 years or older\n* Diagnosis of Urinary Incontinence (defined by the QUID assessment as having subscale score for stress ≥4, and/or urge score ≥ 6)\n* Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance\n* Willing and able to undergo an extensive physical function evaluation\n\nExclusion Criteria:\n\n* Prior surgical intervention for urinary incontinence within the past 12 months\n* Hysterectomy within 12 months\n* Diagnosis of:\n* Pelvic Organ Prolapse beyond the hymenal ring\n* Urogenital Fistula\n* Neurogenic Overactive Bladder (associated with a diagnosis of Multiple -Sclerosis or Stroke within past 12 months)\n* Incomplete Bladder Emptying/Urinary Retention with PVR \\>150 ml (measured by bladder scan)\n* Requires assisted device (4 point cane, walker) for ambulation all /most of the time or wheelchair bound\n* Having significant cognitive impairment or dementia\n* Unsafe to exercise (severe cardiopulmonary disease)\n* Unable/unwilling to provide informed consent\n* Determined otherwise ineligible by the principal investigator'}, 'identificationModule': {'nctId': 'NCT03057834', 'acronym': 'UNITS', 'briefTitle': 'The Urinary Incontinence Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Exploring the Role of Sarcopenia and Functional Impairment on the Non-Surgical Management of Urinary Incontinence in Older Women', 'orgStudyIdInfo': {'id': 'IRB00038710'}, 'secondaryIdInfos': [{'id': 'R03AG056460', 'link': 'https://reporter.nih.gov/quickSearch/R03AG056460', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Functionally impaired', 'description': 'Women with urinary incontinence and short physical performance battery score of \\<9', 'interventionNames': ['Behavioral: Pelvic floor muscle exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Functionally normal', 'description': 'Women with urinary incontinence and short physical performance battery score of \\> 10', 'interventionNames': ['Behavioral: Pelvic floor muscle exercise']}], 'interventions': [{'name': 'Pelvic floor muscle exercise', 'type': 'BEHAVIORAL', 'description': 'Standardized pelvic floor muscle exercise regimen', 'armGroupLabels': ['Functionally impaired', 'Functionally normal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Candace Parker-Autry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}