Multiple Sclerosis, Urinary Bladder, Overactive
Conditions
Keywords
multiple sclerosis, remote, wearables, overactive bladder, pelvic floor physical therapy
Brief summary
The goal is to investigate the feasibility and effects of adding "wearables for the bladder" devices to conventional pelvic floor physical therapy (PFPT) to bladder function, in people with multiple sclerosis (MS).
Detailed description
The participants baseline pelvic floor and bladder function will be assessed by a pelvic floor physical therapist as per standard care, and online MS-symptom questionnaires (i.e., quality of life, bladder bother/symptoms, falls, fatigue, depression). Participants will be trained on the maintenance and use of "wearable for the bladder" (WeB) devices. Participants will receive standard PFPT intervention care, and will be asked to further train using the WeB devices. 8-10 sessions will be conducted over telehealth or in person as per standard protocol. At 12 weeks, participants will return to clinic for pelvic floor and bladder function assessment. A control group will receive standard PFPT intervention care as well as online MS-symptom questionnaires.
Interventions
DEVICEWeB
Participants will be given WeB devices and trained on the use of these devices for home therapy, including the associated mobile applications. Participants will be given home programs and given a schedule to use the WeB devices at home on their own time. At their standard visit participants will have their WeB device use checked and progressed as the therapist deems appropriate. An in-person visit will be scheduled to re-evaluated participants at the 12 week study completion.
OTHERStandard pelvic floor physical therapy
Baseline will consist of a standard PFPT evaluation. Regular visits (tele-video visits or in-person depending on the patients preference) will be scheduled every week for the first 4 weeks and then every other week at the discretion of the therapist. A total of 8-10 visits will be scheduled over the 12 weeks of the study. Participants will be given home exercise programs (as per standard PFPT). An in-person visit will be scheduled to re-evaluated participants at the 12 week study completion.
Sponsors
University of California, San Francisco
National Multiple Sclerosis Society
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three month feasibility pilot with a standard of care control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* MS diagnosis * Assigned Female at birth and whose sex is currently Female * Mild/moderate bladder dysfunction (bowel/bladder functional systems scores = 0-2 or Bladder control scale \>0) * California residents * Wifi in the home and personal smartphone (using Apple operating system) * Able to walk with or without assistive device * Manual muscle test score of 2 or more.
Exclusion criteria
* Undergone treatment for bladder dysfunction symptoms within 3 months * Current urinary tract infection * Recent (\~30 days) relapse * Any cognitive, dexterity or visual impairment so severe that it precludes use of the wearables for the bladder tool or ability to use a smartphone * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Promoter Score | 12 weeks | This is a response to a single question: "How likely would you be to recommend \[participation in a study or treatment like this\] to a friend or family member with Multiple Sclerosis?" Net promoter scores range from 0 (would not recommend) to 10 (would definitely recommend). |
| Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use | 12 weeks | In response to four statements about the ease of use for the wearables for the bladder (WeB): ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 5-20. Lower scores relate to less ease of use. |
| Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness | 12 weeks | In response to nine statements about the Perceived usefulness of the wearables for the bladder (WeB) ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 5-20. Lower scores relate to less perceived usefulness. |
| System usability scale | 12 weeks | It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (5) to Strongly disagree (1) - ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 10-100. Lower scores relate to less usability. |
| Adherence as measured by percent usage | 12 weeks | Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overactive bladder symptom scale; OABSS | Baseline and 12 weeks | The questionnaire consists of 4 questions on overactive bladder symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and urge urinary incontinence (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity. |
| Change in the number of daily leakage episodes | Baseline and 12 weeks | Change in number of leaks per day as measured by the wearables for the bladder application. The patient will manually enter the number of leaks into the application. |
| Change in the frequency of daily voiding episodes | Baseline and 12 weeks | Change in the frequency of voids per day as measured by the wearables for the bladder application. The patient will manually enter voids into the application. |
| Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29) | Baseline and 12 weeks | Measurement of changes in quality of life via the MSQOL-29: consists of seven multi-item subscales: 'physical function' (six items); 'sexual function' (four items); 'bodily pain', 'emotional well-being', 'energy', 'cognitive function' and 'health distress' (three items); and four single-item subscales ('social function', 'health perceptions', 'overall quality of life', and 'change in health') which form two composite scores (Physical Health Composite, (PHC) and Mental Health Composite, (MHC)) |
| Change in the SymptoMScreen survey | Baseline and 9 months | Measurement of changes in quality of life via the SymptoMScreen - a 12 question survey asking about MS symptoms affecting everyday life. Each question is graded on a scale of 0 - not affected at all, to 6 - Total limitation. Scores are summed and range from 0 -72. |
| Satisfaction with using WeB devices | 12 weeks | Using a single question ("Do you like this tool?") graded on a Likert scale (0, do not like at all, 100, like very much). Higher scores indicate higher satisfaction. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORValerie J Block, DPTSc
University of California, San Francisco
Outcome results
None listed