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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
University of California San Francisco, Weill Institute for Neurosciences
San Francisco, California, United States
Net Promoter Score
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).
Time frame: 12 weeks
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use
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.
Time frame: 12 weeks
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness
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.
Time frame: 12 weeks
System usability scale
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.
Time frame: 12 weeks
Adherence as measured by percent usage
Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration.
Time frame: 12 weeks
Change in Overactive bladder symptom scale; OABSS
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.
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Time frame: Baseline and 12 weeks
Change in Overactive bladder symptom scale; OABSS
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.
Time frame: Baseline and 9 months
Change in the number of daily leakage episodes
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.
Time frame: Baseline and 12 weeks
Change in the number of daily leakage episodes
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.
Time frame: Baseline and 9 months
Change in the frequency of daily voiding episodes
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.
Time frame: Baseline and 12 weeks
Change in the frequency of daily voiding episodes
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.
Time frame: Baseline and 9 months
Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)
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))
Time frame: Baseline and 12 weeks
Change in the SymptoMScreen survey
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.
Time frame: Baseline and 9 months
Satisfaction with using WeB devices
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.
Time frame: 12 weeks