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Wearables + Physical Therapy for Overactive Bladder in Multiple Sclerosis (WeB Trial)

N/A
Recruiting
Led By Valerie J Block, DPTSc
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to walk with or without assistive device
MS diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 9 months
Awards & highlights

WeB Trial Summary

This trial will study how technology can help treat bladder issues in people with MS by combining physical therapy & wearables.

Who is the study for?
This trial is for California residents who were assigned female at birth, currently identify as female, have MS with mild to moderate bladder dysfunction but no recent treatments for it. Participants must be able to walk (with or without help), have a manual muscle test score of 2+, and own a smartphone with Wi-Fi at home.Check my eligibility
What is being tested?
The study tests if adding 'wearables for the bladder' (WeB) devices to standard pelvic floor physical therapy can improve bladder function in people with multiple sclerosis. It's an in-home pilot study focusing on feasibility and effects.See study design
What are the potential side effects?
Since this trial involves non-invasive wearables and physical therapy, side effects may include discomfort or skin irritation from the device, muscle soreness from exercises, and potential fatigue.

WeB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk by myself or with help from a device.
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I have been diagnosed with multiple sclerosis (MS).
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I was assigned female at birth and identify as female.
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I have mild to moderate issues controlling my bladder.
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I have mild to moderate issues controlling my bladder.

WeB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence as measured by percent usage
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness
+2 more
Secondary outcome measures
Change in Overactive bladder symptom scale; OABSS
Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)
Change in the SymptoMScreen survey
+3 more
Other outcome measures
Change in Bladder control scale; BLCS
Change in Heart rate variability
Change in application pelvic fitness test; control
+4 more

WeB Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WeB and pelvic floor physical therapy groupExperimental Treatment2 Interventions
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.
Group II: Control pelvic floor physical therapy groupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,933,829 Total Patients Enrolled
23 Trials studying Multiple Sclerosis
2,510 Patients Enrolled for Multiple Sclerosis
National Multiple Sclerosis SocietyOTHER
95 Previous Clinical Trials
9,463 Total Patients Enrolled
93 Trials studying Multiple Sclerosis
9,109 Patients Enrolled for Multiple Sclerosis
Valerie J Block, DPTScPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Standard Pelvic Floor Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05715268 — N/A
Multiple Sclerosis Research Study Groups: WeB and pelvic floor physical therapy group, Control pelvic floor physical therapy group
Multiple Sclerosis Clinical Trial 2023: Standard Pelvic Floor Physical Therapy Highlights & Side Effects. Trial Name: NCT05715268 — N/A
Standard Pelvic Floor Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715268 — N/A
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05715268 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research investigation include older adults aged 75 and above?

"This trial has an age restriction of 18 to 80 years old; any patient that falls within this range is eligible for enrollment."

Answered by AI

Is this research initiative still recruiting participants?

"According to the clinicaltrials.gov database, this particular research endeavour is not currently recruiting participants. Originally posted on March 1st 2023 and updated as recently as January 27th 2023, though there are 584 other trials that are presently seeking volunteers."

Answered by AI

How can I become involved in this research endeavor?

"This medical trial is set to accept 20 participants who are diagnosed with multiple sclerosis, aged between 18 and 80. In order to meet the minimum qualifications for eligibility, patients must be self-identified females assigned female at birth; possess mild/moderate bladder dysfunction based on functional systems scores or Bladder control scale ratings; reside in California with access to a Wifi network and an Apple OS smartphone; demonstrate manual muscle test score of 2 or more (if applicable); and have the ability to walk either independently or aided by assistive devices."

Answered by AI

What are the objectives of this medical investigation?

"The primary measure of this 12-week investigation is the Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of Use. Secondary assessments include variations in daily leakage episodes, voiding frequency, and changes to quality of life as gauged by MSQOL-29's seven multi-item subscales and four single item indices."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
What site did they apply to?
University of California San Francisco, Weill Institute for Neurosciences
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How often are screening visits?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I've had an over active bladder for most of my adulthood. I usually feel as though I have to pee but then when I do pee often not much is there. Its inconvenient and consuming to always need to be around a bathroom. I feel it is something I can train myself out of with help. I have time and am available to help with this study.
PatientReceived no prior treatments
~3 spots leftby Jun 2024