Clinical trial NCT05715268: Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Urinary Bladder, Overactive
Keywords: multiple sclerosis
remote
wearables
overactive bladder
pelvic floor physical therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2023-02-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three month feasibility pilot with a standard of care control
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Net Promoter Score
timeFrame: 12 weeks
measure: Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use
timeFrame: 12 weeks
measure: Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness
timeFrame: 12 weeks
measure: System usability scale
timeFrame: 12 weeks
measure: Adherence as measured by percent usage
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Overactive bladder symptom scale; OABSS
timeFrame: Baseline and 12 weeks
measure: Change in Overactive bladder symptom scale; OABSS
timeFrame: Baseline and 9 months
measure: Change in the number of daily leakage episodes
timeFrame: Baseline and 12 weeks
measure: Change in the number of daily leakage episodes
timeFrame: Baseline and 9 months
measure: Change in the frequency of daily voiding episodes
timeFrame: Baseline and 12 weeks
measure: Change in the frequency of daily voiding episodes
timeFrame: Baseline and 9 months
measure: Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)
timeFrame: Baseline and 12 weeks
measure: Change in the SymptoMScreen survey
timeFrame: Baseline and 9 months
measure: Satisfaction with using WeB devices
timeFrame: 12 weeks
Other outcomes:
measure: Change in average quality of sleep
timeFrame: baseline, and 12 weeks
measure: Change in average daily step count
timeFrame: baseline, and 12 weeks
measure: Change in Heart rate variability
timeFrame: baseline, and 12 weeks
measure: Change in Bladder control scale; BLCS
timeFrame: Baseline and 12 weeks
measure: Change in application pelvic fitness test; control
timeFrame: Baseline and 12 weeks
measure: Change in application pelvic fitness test; speed
timeFrame: Baseline and 12 weeks
measure: Change in application pelvic fitness test; endurance
timeFrame: Baseline and 12 weeks
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco, Weill Institute for Neurosciences
state: California
Study officials:
affiliation: University of California, San Francisco
name: Valerie J Block, DPTSc
role: PRINCIPAL_INVESTIGATOR
References: