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

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Urinary Bladder, Overactive; Multiple Sclerosis

Treatments: Other: Standard pelvic floor physical therapy; Device: WeB

Study type: Interventional

Funder types: Other

Identifiers

NCT05715268

A137172

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

WeB and pelvic floor physical therapy group

Experimental group

Description:

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.

Treatment:

Device: WeB

Other: Standard pelvic floor physical therapy

Control pelvic floor physical therapy group

Active Comparator group

Description:

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.

Treatment:

Other: Standard pelvic floor physical therapy