NCT07451106 Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics
| NCT ID | NCT07451106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Postpartum Bladder Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2024-07-11 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Valerie Block, PT, DPTSc
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07451106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postpartum Bladder Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07451106 currently recruiting?
Yes, NCT07451106 is actively recruiting participants. Contact the research team at valerie.block@ucsf.edu for enrollment information.
Where is the NCT07451106 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07451106 clinical trial?
NCT07451106 is sponsored by University of California, San Francisco. The principal investigator is Valerie Block, PT, DPTSc at University of California, San Francisco. The trial plans to enroll 25 participants.