NCT05715268

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-04-10
• Completion: 2026-07-01
• First posted: 2023-02-06
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study