Multiple Sclerosis, Urinary Bladder Diseases
Conditions
Brief summary
This study will assess the impact of a systematic bladder health screening and disease education regimen as well as the implementation of a referral process on the quality of life of multiple sclerosis patients with bladder dysfunction.
Interventions
BEHAVIORALSystematic Screening and Education Regimen
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.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of relapsing-remitting multiple sclerosis and currently being treated by study doctor
Exclusion criteria
* Diagnosis of primary-progressive, secondary-progressive, or progressive-relapsing multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Baseline, Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | All Enrolled Patients |
|---|---|
| Age, Continuous | 50.4 Years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
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.
Time frame: Baseline, Month 6
Population: Eligible and enrolled subjects who completed the Month 6 visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Patients | 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 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Baseline (BL)-General Health Perception | 39.7 Scores on a Scale | Standard Deviation 23.1 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Chng from BL at M6-General Health Percept (N=111) | 2.5 Scores on a Scale | Standard Deviation 22.3 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | BL-Incontinence Impact | 60.7 Scores on a Scale | Standard Deviation 23.8 |
| All Enrolled Patients | 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 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | BL-Role Limitations (N=111) | 43.8 Scores on a Scale | Standard Deviation 29.6 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Chng from BL at M6-Role Limitations (N=111) | -6.9 Scores on a Scale | Standard Deviation 27.5 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | BL-Physical Limitations (N=111) | 45.3 Scores on a Scale | Standard Deviation 28 |
| All Enrolled Patients | 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 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Chng from BL at M6-Social Limitations (N=110) | -9.0 Scores on a Scale | Standard Deviation 24.5 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | BL-Personal Relations (N=85) | 25.9 Scores on a Scale | Standard Deviation 30.3 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Chng from BL at M6-Personal Relations (N=78) | -9.0 Scores on a Scale | Standard Deviation 24.9 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | BL-Emotions | 35.7 Scores on a Scale | Standard Deviation 28.4 |
| All Enrolled Patients | 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 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | BL-Sleep/Energy | 41.7 Scores on a Scale | Standard Deviation 27.8 |
| All Enrolled Patients | Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores | Chng from BL at M6-Sleep/Energy | -8.2 Scores on a Scale | Standard Deviation 25.1 |
| All Enrolled Patients | 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 |
| All Enrolled Patients | 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 |
Secondary
Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
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.
Time frame: Baseline
Population: Eligible enrolled subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Patients | Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire | Understand how MS can affect the bladder | 94.0 Percentage of Patients |
| All Enrolled Patients | Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire | How to recognize bladder symptoms | 94.0 Percentage of Patients |
| All Enrolled Patients | 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 |
| All Enrolled Patients | Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire | Understand self-help strategies | 88.9 Percentage of Patients |
| All Enrolled Patients | Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire | Better manage their bladder problems | 81.2 Percentage of Patients |