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OpenTrials
Active, Not Recruiting

NCT Number: NCT05715268

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco, Weill Institute for Neurosciences

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WEB

Device

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.

Standard pelvic floor physical therapy

Other

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 outcomes

  1. Net Promoter Score

    Time frame: 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).

  2. Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use

    Time frame: 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.

  3. Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness

    Time frame: 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.

  4. System usability scale

    Time frame: 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.

  5. Adherence as measured by percent usage

    Time frame: 12 weeks

    Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration.

Secondary outcomes

  1. Change in Overactive bladder symptom scale; OABSS

    Time frame: 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.

  2. Change in Overactive bladder symptom scale; OABSS

    Time frame: 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.

  3. Change in the number of daily leakage episodes

    Time frame: 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.

  4. Change in the number of daily leakage episodes

    Time frame: 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.

  5. Change in the frequency of daily voiding episodes

    Time frame: 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.

  6. Change in the frequency of daily voiding episodes

    Time frame: 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.

  7. Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)

    Time frame: 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))

  8. Change in the SymptoMScreen survey

    Time frame: 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.

  9. Satisfaction with using WeB devices

    Time frame: 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.

Other outcomes

  1. Change in average quality of sleep

    Time frame: baseline, and 12 weeks

    Remote monitoring devices will provide passive sleep scores rated as a percentage. Higher percentages reflect better sleep scores.

  2. Change in average daily step count

    Time frame: baseline, and 12 weeks

    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.

  3. Change in Heart rate variability

    Time frame: baseline, and 12 weeks

    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.

  4. Change in Bladder control scale; BLCS

    Time frame: Baseline and 12 weeks

    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)

  5. Change in application pelvic fitness test; control

    Time frame: Baseline and 12 weeks

    Change in pelvic floor muscle control - graded from 0-50

  6. Change in application pelvic fitness test; speed

    Time frame: Baseline and 12 weeks

    Change in pelvic floor muscle contraction speed - graded from 0-10

  7. Change in application pelvic fitness test; endurance

    Time frame: Baseline and 12 weeks

    Change in pelvic floor muscle endurance - graded from 0-20

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study 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

Acronym: WeB

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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