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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07451106
Status
Recruiting
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Conditions

  • Bladder Dysfunction
  • Post-prostatectomy Bladder Dysfunction
  • Postpartum Bladder Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DFree Non-Invasive Bladder Ultrasound — OTHER
    For patient participants: The DFree is used to monitor the bladder fullness and track changes in the bladder fullness over time using an application on a mobile device. It is placed over the lower abdomen using an adhesive patch.
  • Perifit Kegel Exerciser — OTHER
    For (female) patient participants: The Perifit uses a bluetooth connection with mobile devices to allow contractions and relaxation from internal pelvic floor muscles to control video games. It measures the force and duration of contractions.
  • Exit interview — OTHER
    All participants will be asked to complete modified Health IT Usability Evaluation Model (Health-ITUEM) surveys, to evaluate bladder wearable devices in these populations

Study Details

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.

Key Dates

Start date
Jul 11, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Men post-prostatectomy with bladder dysfunction
  • Arm: Postpartum women with bladder dysfunction
  • Arm: Women with bladder dysfunction
  • Arm: Clinicians
    Clinicians will be interviewed at the completion of the study to assess utility of wearables for the bladder in clinical care

Primary Outcome Measure

Comparison between in clinic and wearable post-void-residual [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Francisco Weill Institute for NeurosciencesSan FranciscoCalifornia94158
Valerie J Block, PT, DPTSc
[email protected]
619-841-8377
Valerie Block, PT, DPTSc (PRINCIPAL_INVESTIGATOR)
Jordan E LaBrec, PT, DPT (SUB_INVESTIGATOR)
Jennifer R Kinder, PT, DPTSc (SUB_INVESTIGATOR)
Leah McIntyre, PT, DPT (SUB_INVESTIGATOR)

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By research site
University of California San Francisco Weill Institute for Neurosciences· San Francisco, CA

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