Wearables for the Bladder: an In-home Treatment Feasibility Pilot Stud

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

Running, not recruitingNot a drug-phase studyMS (type not specified)NCT05715268

What it found

Still running

No result yet.

What was tested

Treatment tested

  • WeB

Given to everyone in the trial

  • Standard pelvic floor physical therapy

What it measured

Main measures

  • Net Promoter Score

    12 weeks

  • Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use

    12 weeks

    Bladder, bowel and sexual function

  • Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness

    12 weeks

    Bladder, bowel and sexual function

  • System usability scale

    12 weeks

  • Adherence as measured by percent usage

    12 weeks

    Quality of life (reported by participants)

Other measures (9)

  • Change in Overactive bladder symptom scale; OABSS

    Baseline and 12 weeks

    Bladder, bowel and sexual function

  • Change in Overactive bladder symptom scale; OABSS

    Baseline and 9 months

    Bladder, bowel and sexual function

  • Change in the number of daily leakage episodes

    Baseline and 12 weeks

    Bladder, bowel and sexual function

  • Change in the number of daily leakage episodes

    Baseline and 9 months

    Bladder, bowel and sexual function

  • Change in the frequency of daily voiding episodes

    Baseline and 12 weeks

    Bladder, bowel and sexual function

  • Change in the frequency of daily voiding episodes

    Baseline and 9 months

    Bladder, bowel and sexual function

  • Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)

    Baseline and 12 weeks

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

  • Change in the SymptoMScreen survey

    Baseline and 9 months

    Quality of life (reported by participants)

  • Satisfaction with using WeB devices

    12 weeks

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 80

Show the full criteria

Inclusion criteria

* 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.

Exclusion criteria

* 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

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History

    1. Started

      Mar 2023

    2. Main results due

      Dec 2026

    3. Finished

      Jan 2027

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