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

N/A

Waitlist Available

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

MS diagnosis

Assigned Female at birth and currently Female

Must not have

Current urinary tract infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 9 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple sclerosis (MS).

Select...

I was assigned female at birth and identify as female.

Select...

I have mild to moderate issues controlling my bladder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a urinary tract infection right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

Change in Bladder control scale; BLCS

Change in Heart rate variability

Change in application pelvic fitness test; control

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met