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

NCT ID: NCT05715268

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-09-25

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.

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WeB and pelvic floor physical therapy group

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 Type: EXPERIMENTAL

WeB

Intervention Type: 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.

Standard pelvic floor physical therapy

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Standard pelvic floor physical therapy

Intervention Type: 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.

Interventions

WeB

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.

Intervention Type: DEVICE

Standard pelvic floor physical therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie J Block, DPTSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco, Weill Institute for Neurosciences

San Francisco, California, United States

Countries

United States

Other Identifiers

A137172

Identifier Type: -

Identifier Source: org_study_id