Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study
- Conditions
- Urinary Bladder, OveractiveMultiple Sclerosis
- Interventions
- Device: WeBOther: Standard pelvic floor physical therapy
- Registration Number
- NCT05715268
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 20
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WeB and pelvic floor physical therapy group WeB This group will receive standard PFPT as well as WeB device for 12 weeks, and MS-symptom (including bladder bother) related questionnaires at baseline, 12 weeks and 6 months post intervention. Participants will also be provided with a remote activity monitor to use during the study. Control pelvic floor physical therapy group Standard pelvic floor physical therapy This group will receive standard PFPT for 12 weeks. MS-symptom (including bladder bother) related questionnaires at baseline, 12 weeks and 6 months after the last PFPT visit. Patients will be invited to use WeB devices after this time. WeB and pelvic floor physical therapy group Standard pelvic floor physical therapy This group will receive standard PFPT as well as WeB device for 12 weeks, and MS-symptom (including bladder bother) related questionnaires at baseline, 12 weeks and 6 months post intervention. Participants will also be provided with a remote activity monitor to use during the study.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Change in the number of daily leakage episodes Baseline and 9 months 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 Overactive bladder symptom scale; OABSS Baseline and 9 months 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 frequency of daily voiding episodes Baseline and 9 months 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 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.
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))
Trial Locations
- Locations (1)
University of California San Francisco, Weill Institute for Neurosciences
🇺🇸San Francisco, California, United States