Wearables + Physical Therapy for Overactive Bladder in Multiple Sclerosis

(WeB Trial)

Overseen By Valerie J Block, DPTSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Recent relapse, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding special "wearable" devices to regular pelvic floor exercises can improve bladder function in people with multiple sclerosis (MS). It aims to determine if these devices enhance outcomes compared to exercises alone. Participants will either use the wearable devices alongside standard pelvic floor physical therapy or only undergo the therapy, with an opportunity to try the devices later. The trial seeks California residents with MS who have some bladder control issues and can walk, even if they require a device like a cane.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for those with MS.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these wearables for the bladder are safe for people with multiple sclerosis?

Research has shown that wearable devices for bladder control are generally safe for people with overactive bladder symptoms. One study found these devices safe and easy to use at home, which is encouraging for people with multiple sclerosis who also have bladder issues.

Another study found similar devices effective for treating overactive bladder and related symptoms. This suggests that the wearables being tested are well-tolerated and could be a promising option for managing bladder problems.

While specific data on this exact wearable is not available, existing research indicates a good safety profile. This suggests the device is unlikely to cause harm, which should reassure anyone considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of wearables and physical therapy for overactive bladder in multiple sclerosis because it introduces a new layer of monitoring and personalization to treatment. Unlike traditional pelvic floor physical therapy, this approach integrates a wearable device, providing real-time feedback and remote monitoring of activity. This has the potential to enhance patient engagement and adherence, while also allowing for more tailored adjustments to the therapy based on individual progress. This innovative method could lead to better management of symptoms and improved quality of life for patients with MS.

What evidence suggests that wearables for the bladder and pelvic floor physical therapy are effective for overactive bladder in multiple sclerosis?

Research has shown that using wearable devices for the bladder, along with pelvic floor physical therapy (PFPT), may improve bladder function in people with multiple sclerosis (MS). In this trial, one group will receive both the WeB device and standard PFPT, while another group will receive only standard PFPT. Studies have found that wearable devices, like the Avation device, effectively treat symptoms of an overactive bladder, such as urgency and incontinence. These wearables continuously monitor bladder issues, providing more accurate information than occasional clinic visits. They might help with bladder problems that affect over 85% of people with MS. While more research is needed, early results suggest that wearables combined with PFPT could be promising for managing bladder problems in MS patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Valerie J Block, DPTSc

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

California residents

Wifi in the home and personal smartphone (using Apple operating system)

I can walk by myself or with help from a device.

Exclusion Criteria

Pregnancy

I have been treated for bladder problems in the last 3 months.

I have a urinary tract infection right now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants' baseline pelvic floor and bladder function assessed by a pelvic floor physical therapist and completion of online MS-symptom questionnaires

1 week

1 visit (in-person or virtual)

Treatment

Participants receive standard PFPT intervention care and train using WeB devices over 12 weeks

12 weeks

8-10 sessions (telehealth or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MS-symptom questionnaires at 12 weeks and 6 months post-intervention

6 months

Open-label extension (optional)

Patients will be invited to use WeB devices after the main trial period

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Standard Pelvic Floor Physical Therapy
• WeB

Trial Overview 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.

How Is the Trial Designed?

Group I: WeB and pelvic floor physical therapy group Experimental Treatment 2 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 group Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11491565/

Wearables for the Bladder: Stakeholder Perspectives on ... Bladder dysfunction (BD) is common in people with multiple sclerosis (MS) and can reduce participation in daily life.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05715268

Study Details | NCT05715268 | Wearables for the Bladder ... The goal is to investigate the feasibility and effects of adding "wearables for the bladder" devices to conventional pelvic floor physical therapy (PFPT) to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12455868/

Continuous Monitoring of Bladder Dysfunction in People ... Bladder dysfunction affects over 85% of people with multiple sclerosis (PwMS), yet current assessment methods are limited to periodic in‐clinic evaluations ...

4. goldjournal.net goldjournal.net/article/S0090-4295(23)00937-8/fulltext

A Multicenter Study Evaluating the FREquency of Use and ... The Avation device demonstrates promising efficacy in treating adults with overactive bladder and urge urinary incontinence.

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02262-z

Efficacy and safety of non-invasive low-frequency tibial nerve ... The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation. Trial registration number: NCT04999657.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01369485

NCT01369485 | Safety and Effectiveness of a Non-invasive ... Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6256042/

Feasibility of using a novel non-invasive ambulatory tibial ... This novel ambulatory transcutaneous TNS (TTNS) device is safe and acceptable for use in patients reporting OAB symptoms as a form of home-based neuromodulation ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0090429523009378

A Multicenter Study Evaluating the FREquency of Use and ... The Avation device demonstrates promising efficacy in treating adults with overactive bladder and urge urinary incontinence.