Multiple SclerosisWeBNCT05715268
Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study
A study testing WeB and Standard pelvic floor physical therapy in people with Multiple Sclerosis and Urinary Bladder, Overactive, run by University of California, San Francisco at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Multiple Sclerosis, Urinary Bladder, Overactive
- What is being tested?
- WeB and Standard pelvic floor physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco, Weill Institute for Neurosciences
San Francisco, California, 94158
About this study
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
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).
Read the 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.
- Conditions
- Multiple Sclerosis, Urinary Bladder, Overactive
- Being tested
- WeB, Standard pelvic floor physical therapy
- Keywords
- multiple sclerosis, remote, wearables, overactive bladder, pelvic floor physical therapy
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeBDevice
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| WeB and pelvic floor physical therapy group | Experimental | 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. Receives: Device: WeB; Other: Standard pelvic floor physical therapy |
| Control pelvic floor physical therapy group | Active comparator | 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. Receives: Other: Standard pelvic floor physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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))
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start15 Mar 2023
- Primary completion21 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three month feasibility pilot with a standard of care control
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Valerie J Block, DPTSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715268
- Sponsor's protocol ID
- A137172
- Acronym
- WeB
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05715268
- Acronym / sponsor ID
- WeB / A137172
- Conditions
- Multiple Sclerosis, Urinary Bladder, Overactive
- Keywords
- multiple sclerosis, remote, wearables, overactive bladder, pelvic floor physical therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Three month feasibility pilot with a standard of care control
| Arm | Type | Receives |
|---|---|---|
| WeB and pelvic floor physical therapy group | Experimental | Device: WeB, Other: Standard pelvic floor physical therapyThis 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 | Active comparator | Other: Standard pelvic floor physical therapyThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WeBParticipants 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. | Device | WeB and pelvic floor physical therapy group |
| Standard pelvic floor physical therapyBaseline 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. | Other | Control pelvic floor physical therapy group, WeB and pelvic floor physical therapy group |
Primary outcome
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).
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.
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.
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.
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.
9 secondary outcomes
Change in Overactive bladder symptom scale; OABSS
Time frame: Baseline and 12 weeks
Change in Overactive bladder symptom scale; OABSS
Time frame: Baseline and 9 months
Change in the number of daily leakage episodes
Time frame: Baseline and 12 weeks
Change in the number of daily leakage episodes
Time frame: Baseline and 9 months
Change in the frequency of daily voiding episodes
Time frame: Baseline and 12 weeks
Change in the frequency of daily voiding episodes
Time frame: Baseline and 9 months
Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)
Time frame: Baseline and 12 weeks
Change in the SymptoMScreen survey
Time frame: Baseline and 9 months
Satisfaction with using WeB devices
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie J Block, DPTSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeB and Standard pelvic floor physical therapy in people with Multiple Sclerosis and Urinary Bladder, Overactive, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Promoter Score (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.