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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Wearables + Physical Therapy for Overactive Bladder in Multiple Sclerosis?

Research shows that pelvic floor muscle training, a key part of the treatment, can improve urinary symptoms and quality of life in people with multiple sclerosis. Additionally, pelvic floor rehabilitation, which includes exercises and sometimes electrical stimulation, has been found effective for managing bladder issues in these patients. ^{1 2 3 4 5}

Is pelvic floor physical therapy safe for people with multiple sclerosis?

Pelvic floor muscle training is generally considered safe for people with multiple sclerosis, as studies have shown it can improve quality of life and reduce symptoms like urinary incontinence without significant safety concerns. ^{1 2 4 6 7}

How is Standard Pelvic Floor Physical Therapy different from other treatments for overactive bladder in multiple sclerosis?

Standard Pelvic Floor Physical Therapy is unique because it focuses on strengthening the pelvic floor muscles, which can help control bladder function, rather than relying on medications. This approach is particularly beneficial for individuals with multiple sclerosis, as it addresses the muscle control issues that can contribute to bladder problems. ^{1 2 3 6 8}

Research Team

Valerie J Block, DPTSc

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Under treatment of overactive bladder symptoms in patients with multiple sclerosis: an ancillary analysis of the NARCOMS Patient Registry. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

A comparative study of pelvic floor muscle training in women with multiple sclerosis: its impact on lower urinary tract symptoms and quality of life. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial: outcomes of bladder rehabilitation in persons with multiple sclerosis. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training on urinary incontinence and sexual function in people with multiple sclerosis: A systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pelvic floor rehabilitation is effective in patients with multiple sclerosis. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training in the treatment of lower urinary tract dysfunction in women with multiple sclerosis. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Pelvic Floor Muscle Training and Its Benefits for Multiple Sclerosis Patients Suffering From Urinary Incontinence and Sexual Dysfunction. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Effect of Pelvic Floor Muscle Contraction on Detrusor Overactivity Pressure in Neurogenic and Nonneurogenic Women During Urodynamic Study: A Cross-Sectional Study. [2023]