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Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study (WeB)

Primary Purpose

Multiple Sclerosis, Urinary Bladder, Overactive

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WeB
Standard pelvic floor physical therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, remote, wearables, overactive bladder, pelvic floor physical therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco, Weill Institute for NeurosciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WeB and pelvic floor physical therapy group

Control pelvic floor physical therapy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
Adherence as measured by percent usage
Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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))
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.
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.

Full Information

First Posted
January 26, 2023
Last Updated
May 10, 2023
Sponsor
University of California, San Francisco
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT05715268
Brief Title
Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study
Acronym
WeB
Official Title
Moving MS Bladder Dysfunction Into the 21st Century: Developing Novel and Accessible Ways to Treat Dysfunction in the Home - a Three Month Single Arm Open Label Feasibility Pilot With Waitlist Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Urinary Bladder, Overactive
Keywords
multiple sclerosis, remote, wearables, overactive bladder, pelvic floor physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three month feasibility pilot with a standard of care control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WeB and pelvic floor physical therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control pelvic floor physical therapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WeB
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard pelvic floor physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Net Promoter Score
Description
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
Title
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use
Description
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
Title
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness
Description
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
Title
System usability scale
Description
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
Title
Adherence as measured by percent usage
Description
Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Overactive bladder symptom scale; OABSS
Description
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 12 weeks
Title
Change in Overactive bladder symptom scale; OABSS
Description
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
Title
Change in the number of daily leakage episodes
Description
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
Title
Change in the number of daily leakage episodes
Description
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
Title
Change in the frequency of daily voiding episodes
Description
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
Title
Change in the frequency of daily voiding episodes
Description
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
Title
Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)
Description
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
Title
Change in the SymptoMScreen survey
Description
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
Title
Satisfaction with using WeB devices
Description
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
Other Pre-specified Outcome Measures:
Title
Change in average quality of sleep
Description
Remote monitoring devices will provide passive sleep scores rated as a percentage. Higher percentages reflect better sleep scores.
Time Frame
baseline, and 12 weeks
Title
Change in average daily step count
Description
Remote monitoring devices will provide passive daily step count as a number above 0- the daily step counts over the study will be averaged. Higher steps reflect more physical activity.
Time Frame
baseline, and 12 weeks
Title
Change in Heart rate variability
Description
Remote monitoring devices will provide passive heart rate variability (in milliseconds) - heart rate variability is the variation in the time between heartbeats, and lowering heart rate variability may indicate an increase in stress or strain.
Time Frame
baseline, and 12 weeks
Title
Change in Bladder control scale; BLCS
Description
Four-item instrument assessing the extent to which bladder problems have an impact on everyday activities over the last 4 weeks. Raw scores are summed to create a total score ranging from 0 to 22 (higher scores indicate more severe bladder bother)
Time Frame
Baseline and 12 weeks
Title
Change in application pelvic fitness test; control
Description
Change in pelvic floor muscle control - graded from 0-50
Time Frame
Baseline and 12 weeks
Title
Change in application pelvic fitness test; speed
Description
Change in pelvic floor muscle contraction speed - graded from 0-10
Time Frame
Baseline and 12 weeks
Title
Change in application pelvic fitness test; endurance
Description
Change in pelvic floor muscle endurance - graded from 0-20
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie J Block, DPTSc
Phone
‭+1 (415) 502-7208
Email
valerie.block@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie J Block, DPTSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco, Weill Institute for Neurosciences
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie J Block, DPTSc
Phone
415-502-7208
Email
valerie.block@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study

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