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

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715268
• Other study ID #: A137172
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: Valerie J Block, DPTSc
• Phone: ?+1 (415) 502-7208
• Email: valerie.block[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Urinary Bladder, Overactive

Intervention

Device:
• WeB
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.

Other:
• Standard 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.

Locations

Country	Name	City	State
United States	University of California San Francisco, Weill Institute for Neurosciences	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in average quality of sleep	Remote monitoring devices will provide passive sleep scores rated as a percentage. Higher percentages reflect better sleep scores.	baseline, and 12 weeks
Other	Change in average daily step count	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.	baseline, and 12 weeks
Other	Change in Heart rate variability	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.	baseline, and 12 weeks
Other	Change in Bladder control scale; BLCS	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)	Baseline and 12 weeks
Other	Change in application pelvic fitness test; control	Change in pelvic floor muscle control - graded from 0-50	Baseline and 12 weeks
Other	Change in application pelvic fitness test; speed	Change in pelvic floor muscle contraction speed - graded from 0-10	Baseline and 12 weeks
Other	Change in application pelvic fitness test; endurance	Change in pelvic floor muscle endurance - graded from 0-20	Baseline and 12 weeks
Primary	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).	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	Adherence as measured by percent usage	Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration.	12 weeks
Secondary	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.	Baseline and 12 weeks
Secondary	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.	Baseline and 9 months
Secondary	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.	Baseline and 12 weeks
Secondary	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.	Baseline and 9 months
Secondary	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.	Baseline and 12 weeks
Secondary	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.	Baseline and 9 months
Secondary	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))	Baseline and 12 weeks
Secondary	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.	Baseline and 9 months
Secondary	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.	12 weeks