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NCT07451106 · ClinicalTrials.gov registry record
Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics
A clinical trial of Bladder Dysfunction and Postpartum Bladder Dysfunction, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- 25
- Enrollment target
- 1
- Study location
NCT07451106 is a study of Bladder Dysfunction and Postpartum Bladder Dysfunction that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 25 participants, below the 553-participant average among 4 other Bladder Dysfunction trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07451106, a study of Bladder Dysfunction and Postpartum Bladder Dysfunction, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- 25 participants
- Enrollment target
- 1
- Study location
Study 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 mo
Conditions Studied
Interventions
- OTHER DFree Non-Invasive Bladder Ultrasound
- OTHER Perifit Kegel Exerciser
- OTHER Exit interview
Study Locations (1)
California
- University of California San Francisco Weill Institute for Neurosciences - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2026-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07451106
The ClinicalTrials.gov registry entry for NCT07451106 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 553-participant average among 4 other Bladder Dysfunction trials with a reported enrollment target (95% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Bladder Dysfunction appearing as the primary indexed condition, and to 3 interventions - of which DFree Non-Invasive Bladder Ultrasound is the first listed.
NCT07451106 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT07451106 about?
NCT07451106 is a clinical study titled "Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics". 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, bet...
What is the current status of trial NCT07451106?
This trial is currently recruiting. The enrollment target is 25 participants. The study started on 2024-07-11. Estimated completion is 2026-07.
What conditions does trial NCT07451106 study?
This clinical trial studies the following conditions: Bladder Dysfunction, Postpartum Bladder Dysfunction, Post-prostatectomy Bladder Dysfunction.
What interventions are being tested in trial NCT07451106?
The interventions under investigation include: DFree Non-Invasive Bladder Ultrasound (OTHER), Perifit Kegel Exerciser (OTHER), Exit interview (OTHER).
Who is sponsoring clinical trial NCT07451106?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07451106 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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