This study is in progress, not accepting new patients

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

a study on Multiple Sclerosis Overactive Bladder

Summary

Eligibility
for females ages 18-80 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Valerie J Block, DPTSc

Description

Summary

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).

Official Title

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

Details

The participants baseline pelvic floor and bladder function will be assessed by a pelvic floor physical therapist as per standard care, and online MS-symptom questionnaires (i.e., quality of life, bladder bother/symptoms, falls, fatigue, depression). Participants will be trained on the maintenance and use of "wearable for the bladder" (WeB) devices. Participants will receive standard PFPT intervention care, and will be asked to further train using the WeB devices. 8-10 sessions will be conducted over telehealth or in person as per standard protocol. At 12 weeks, participants will return to clinic for pelvic floor and bladder function assessment.

A control group will receive standard PFPT intervention care as well as online MS-symptom questionnaires.

Keywords

Multiple Sclerosis, Urinary Bladder, Overactive, remote, wearables, overactive bladder, pelvic floor physical therapy, Overactive Urinary Bladder, Sclerosis, WeB

Eligibility

You can join if…

Open to females ages 18-80

  • 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.

You CAN'T join if...

  • 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

Location

  • UCSF, Weill Institute for Neurosciences
    San Francisco California 94158 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05715268
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated