Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Valerie Block, PT, DPTSc (ucsf)
Headshot of Valerie Block
Valerie Block

Description

Summary

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.

Keywords

Postpartum Bladder Dysfunction, Post-prostatectomy Bladder Dysfunction, Bladder Dysfunction, pelvic health physical therapy, wearables, DFree Non-Invasive Bladder Ultrasound, Perifit Kegel Exerciser, Exit interview

Eligibility

You can join if…

Open to people ages 18 years and up

  • Referral for pelvic health physical therapy
  • 18 years of age or older
  • Postpartum women: 8 or more weeks postpartum, manual muscle test greater than or equal to 2/5 pelvic floor muscle strength via Modified Oxford Scale
  • Men: status post radical prostatectomy after catheter removal

You CAN'T join if...

  • cognitive, dexterity or visual impairment so severe that it precludes use of the neurotechnology tool or ability to use a smartphone
  • Postpartum women: any unhealed tears from childbirth, active vaginal infection or unresolved uterine bleeding, currently pregnant, have seen a pelvic health physical therapist in the past 3 months
  • Men: status post another surgery related to prostate, catheter placement more than 1 week after radical prostatectomy, post-op infection

Location

  • University of California San Francisco Weill Institute for Neurosciences accepting new patients
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • Valerie Block, PT, DPTSc (ucsf)
    Assistant Professor, Physical Therapy, School of Medicine. Authored (or co-authored) 30 research publications. Research interests: Rehabilitation · Neurology · Neuro-rehabilitation · Multiple sclerosis · Physical Therapy · Remote monitoring · Tele-rehabilitation

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07451106
Study Type
Observational
Participants
Expecting 25 study participants
Last Updated