Actively Recruiting

Age: 18Years +
All Genders
NCT07451106

Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics

Led by University of California, San Francisco · Updated on 2026-03-05

25

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pelvic health physical therapy (PHPT) is an evidence-based intervention for bladder dysfunction (BD) and pelvic floor disorders (PFD) in men postprostatectomy, and postpartum women. However, there is a dearth of objective outcome measures - in particular, those that can capture changes remotely, between clinic visits. In other domains, such as physical activity, wearable digital devices have started to fill this gap. The investigators aim to evaluate if commercially available wearables for the bladder (WeB) can provide valid, objective outcomes to evaluate, monitor and treat people with BD and PFD. The WeB toolkit, comprising a wearable bladder ultrasound device and an intravaginal exerciser (women only), eventually aims to provide real-world, actionable data to both users and healthcare providers, thereby improving patient outcomes through closed-loop interventions. Preliminary studies in women with multiple sclerosis have shown strong associations with gold-standard clinical measures, suggesting that WeB tools could revolutionize care for these patients. However, the effectiveness of these tools in a wider range of patient demographics, especially postpartum women, and men, has yet to be established. The investigators seeks to extend the promising pilot findings to these additional 'special' populations seen in the PHPT clinic. The investigators hypothesize that the WeB tools will retain their accuracy and utility across these diverse groups. The investigators plan to i) validate WeB in these special populations against gold-standard clinical measures for BD, ii) evaluate the responsiveness of WeB tools to changes in outcomes before and after PHPT and iii) assess user experience in these populations. By ensuring the WeB tools' broad applicability, this research seeks to close the gap in continuous care and enable objective, personalized treatment strategies. The outcomes will have significant implications for the management of BD and PFD, potentially offering a more inclusive and empowering approach to patient care in women postpartum and men post-prostatectomy.

CONDITIONS

Official Title

Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Referral for pelvic health physical therapy
  • 18 years of age or older
  • Postpartum women must be at least 8 weeks postpartum with pelvic floor muscle strength of 2/5 or greater by Modified Oxford Scale
  • Men must be post radical prostatectomy after catheter removal
Not Eligible

You will not qualify if you...

  • Severe cognitive, dexterity, or visual impairments that prevent use of the neurotechnology tool or smartphone
  • Postpartum women with unhealed childbirth tears, active vaginal infection, unresolved uterine bleeding, current pregnancy, or pelvic health physical therapy in the past 3 months
  • Men with another prostate-related surgery, catheter placement more than 1 week after prostatectomy, or post-operative infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California San Francisco Weill Institute for Neurosciences

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

V

Valerie J Block, PT, DPTSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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