Trial Outcomes & Findings for Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns (NCT NCT01930799)
NCT ID: NCT01930799
Last Updated: 2016-05-27
Results Overview
The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.
COMPLETED
PHASE4
120 participants
Baseline, Month 6
2016-05-27
Participant Flow
Participant milestones
| Measure |
All Enrolled Patients
Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
|
|---|---|
|
Overall Study
STARTED
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120
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
8
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Reasons for withdrawal
| Measure |
All Enrolled Patients
Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
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|
Overall Study
Lost to Follow-up
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5
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Baseline Characteristics
Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
Baseline characteristics by cohort
| Measure |
All Enrolled Patients
n=120 Participants
Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
|
|---|---|
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Age, Continuous
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50.4 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
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103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Eligible and enrolled subjects who completed the Month 6 visit
The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.
Outcome measures
| Measure |
All Enrolled Patients
n=112 Participants
Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
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|---|---|
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Personal Relations (N=85)
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25.9 Scores on a Scale
Standard Deviation 30.3
|
|
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Baseline (BL)-General Health Perception
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39.7 Scores on a Scale
Standard Deviation 23.1
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-General Health Percept (N=111)
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2.5 Scores on a Scale
Standard Deviation 22.3
|
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Incontinence Impact
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60.7 Scores on a Scale
Standard Deviation 23.8
|
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Incontinence Impact (N=111)
|
1.2 Scores on a Scale
Standard Deviation 24.2
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Role Limitations (N=111)
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43.8 Scores on a Scale
Standard Deviation 29.6
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Role Limitations (N=111)
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-6.9 Scores on a Scale
Standard Deviation 27.5
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Physical Limitations (N=111)
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45.3 Scores on a Scale
Standard Deviation 28.0
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|
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Physical Limitations (N=111)
|
-9.8 Scores on a Scale
Standard Deviation 26.3
|
|
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Social Limitations (N=110)
|
31.7 Scores on a Scale
Standard Deviation 28.6
|
|
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Social Limitations (N=110)
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-9.0 Scores on a Scale
Standard Deviation 24.5
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Personal Relations (N=78)
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-9.0 Scores on a Scale
Standard Deviation 24.9
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Emotions
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35.7 Scores on a Scale
Standard Deviation 28.4
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Emotions
|
-9.0 Scores on a Scale
Standard Deviation 21.8
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Sleep/Energy
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41.7 Scores on a Scale
Standard Deviation 27.8
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Sleep/Energy
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-8.2 Scores on a Scale
Standard Deviation 25.1
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
BL-Severity Measures
|
46.9 Scores on a Scale
Standard Deviation 23.7
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Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Chng from BL at M6-Severity Measures
|
-5.7 Scores on a Scale
Standard Deviation 17.7
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SECONDARY outcome
Timeframe: BaselinePopulation: Eligible enrolled subjects
The Patient Post-Video Questionnaire was based on 5 individual questions assessing the patient's perception of the utility of the video in helping them 1) understand how MS can affect the bladder, 2) how to recognize bladder symptoms, 3) understand various treatment options, 4) understand self-help strategies, and 5) better manage their bladder problems. Percentages represent the proportion of patients who "agree/completely agree" with each question. Patients viewed the video at the Baseline visit, then completed the Patient Post-Video Questionnaire immediately after viewing the video at the Baseline visit.
Outcome measures
| Measure |
All Enrolled Patients
n=117 Participants
Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
|
|---|---|
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Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
Understand how MS can affect the bladder
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94.0 Percentage of Patients
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Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
How to recognize bladder symptoms
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94.0 Percentage of Patients
|
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Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
Understand various treatment options
|
94.0 Percentage of Patients
|
|
Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
Understand self-help strategies
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88.9 Percentage of Patients
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Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
Better manage their bladder problems
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81.2 Percentage of Patients
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Adverse Events
All Enrolled Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER