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

NCT05715268 | Active Not Recruiting FDA Device

• 1 other identifier: A137172
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive

Keywords

multiple sclerosis; remote; wearables; overactive bladder; pelvic floor physical therapy

Outcome Measures

Primary Outcomes (5)

• Net Promoter Score

  This is a response to a single question: "How likely would you be to recommend \[participation in a study or treatment like this\] to a friend or family member with Multiple Sclerosis?" Net promoter scores range from 0 (would not recommend) to 10 (would definitely recommend).

  12 weeks

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

  In response to four statements about the ease of use for the wearables for the bladder (WeB): ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 5-20. Lower scores relate to less ease of use.

  12 weeks

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

  In response to nine statements about the Perceived usefulness of the wearables for the bladder (WeB) ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 5-20. Lower scores relate to less perceived usefulness.

  12 weeks

• System usability scale

  It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (5) to Strongly disagree (1) - ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 10-100. Lower scores relate to less usability.

  12 weeks

• Adherence as measured by percent usage

  Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration.

  12 weeks

Secondary Outcomes (9)

• Change in Overactive bladder symptom scale; OABSS

  Baseline and 12 weeks

• Change in Overactive bladder symptom scale; OABSS

  Baseline and 9 months

• Change in the number of daily leakage episodes

  Baseline and 12 weeks

• Change in the number of daily leakage episodes

  Baseline and 9 months

• Change in the frequency of daily voiding episodes

  Baseline and 12 weeks

Other Outcomes (7)

• Change in average quality of sleep

  baseline, and 12 weeks

• Change in average daily step count

  baseline, and 12 weeks

• Change in Heart rate variability

  baseline, and 12 weeks

Study Arms (2)

WeB and pelvic floor physical therapy group

EXPERIMENTAL

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.

Device: WeB; Other: Standard pelvic floor physical therapy

Control pelvic floor physical therapy group

ACTIVE COMPARATOR

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.

Other: Standard pelvic floor physical therapy

Interventions

WeB DEVICE

Participants will be given WeB devices and trained on the use of these devices for home therapy, including the associated mobile applications. Participants will be given home programs and given a schedule to use the WeB devices at home on their own time. At their standard visit participants will have their WeB device use checked and progressed as the therapist deems appropriate. An in-person visit will be scheduled to re-evaluated participants at the 12 week study completion.

WeB and pelvic floor physical therapy group

Standard pelvic floor physical therapy OTHER

Baseline will consist of a standard PFPT evaluation. Regular visits (tele-video visits or in-person depending on the patients preference) will be scheduled every week for the first 4 weeks and then every other week at the discretion of the therapist. A total of 8-10 visits will be scheduled over the 12 weeks of the study. Participants will be given home exercise programs (as per standard PFPT). An in-person visit will be scheduled to re-evaluated participants at the 12 week study completion.

Control pelvic floor physical therapy group; WeB and pelvic floor physical therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of California San Francisco, Weill Institute for Neurosciences

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valerie J Block, DPTSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three month feasibility pilot with a standard of care control

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: March 15, 2023
• Primary Completion: April 10, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)