Exploring Wearable Devices for Bladder Dysfunction in Pelvic Health Physical Therapy
This observational study is exploring how well wearable devices can help people with bladder problems. It's looking at two devices: the DFree Non-Invasive Bladder Ultrasound, which monitors bladder fullness, and the Perifit Kegel Exerciser, which helps with pelvic floor muscle exercises. The study aims to see if these devices provide useful information for both patients and their physical therapists. You might be able to join if you are 18 or older, are receiving pelvic health physical therapy, and have bladder dysfunction after childbirth (postpartum) or prostate surgery (post-prostatectomy). The researchers want to enroll 25 participants and will assess the usefulness of these wearables over about three months.
- Study design
- This is an observational study with a planned enrollment of 25 participants. It is not a randomized or blinded study.
- What's involved
- You would use either the DFree Non-Invasive Bladder Ultrasound or the Perifit Kegel Exerciser. All participants will also complete an exit interview with surveys.
- Compensation
- Not stated in the trial record.
- Follow-up
- The usefulness of the bladder wearables will be measured through study completion, an average of 3 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics
At a glance
Conditions
NCT07451106
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of California San Francisco Weill Institute for Neurosciences
San Francisco, Californiano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Valerie Block, PT, DPTSc · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Comparison between in clinic and wearable post-void-residualbaseline
Wearable ultrasound (DFree) derived post-void-residual validation in post prostatectomy and post-partum populations. Logistic regression, to evaluate associations while controlling for potential confounding factors. Intraclass correlation coefficients (ICC) and the smallest real difference (SRD) will evaluate the smallest change that can be considered meaningful.
- Bladder wearables - usefulness (patient groups)through study completion, an average of 3 months
Qualitative (modified Health IT Usability Evaluation Model) survey evaluating bladder wearable devices in these populations - assessing patient preference, perceived usability and effectiveness (scored 1-5 on likert scale)
- Bladder wearables - usefulness (clinician)through study completion, an average of 3 month
Clinicians will complete the Health ITUES questionnaire and asked to rate the following questions on a likert scale from 0-5: 1) how useful the devices are for helping patients reach physical therapy goals
- Feasibility of deploying bladder wearablesthrough study completion, an average of 3 months
will calculate the % of participants completing pelvic health physical therapy and still using the tool(s), considering the satisfaction questionnaire feedback. Generalized linear models with Gamma variance to account for potential covariates, including age, vaginal vs cesarean delivery, time postpartum. A tool with \>75% adherence will be considered for further studies; reasons for lower adherence will be explored through exit surveys and be classified according to whether barriers to adherence can be addressed or not.