NCT Number: NCT07451106
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
San Francisco, California, 94158, United States
Location status: Recruiting
Jennifer R Kinder, PT, DPTSc
SUB_INVESTIGATOR
Jordan E LaBrec, PT, DPT
SUB_INVESTIGATOR
Leah McIntyre, PT, DPT
SUB_INVESTIGATOR
Valerie Block, PT, DPTSc
PRINCIPAL_INVESTIGATOR
Valerie J Block, PT, DPTSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
All participants will be asked to complete modified Health IT Usability Evaluation Model (Health-ITUEM) surveys, to evaluate bladder wearable devices in these populations
Time frame: baseline
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.
Time frame: 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)
Time frame: 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
Time frame: through 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.
Time frame: through study completion, an average of 3 months
Paired t-test for pre-post standard pelvic health physical therapy, individually for general and postpartum groups. Pairwise comparisons may be performed between specific outcomes of interest.
Time frame: at study completion - an average of 1 year
Clinicians will complete the Health ITUES questionnaire and asked to rate the following questions on a likert scale from 0-5: how much they think these devices will be usable for patients in their clinical practice
Time frame: at study completion - an average of 3 months post baseline
Health IT Usability Evaluation Model (Health-ITUEM) survey to evaluate bladder wearable devices (1-5 scale) - assessing patient perceived effectiveness. Asking if they found the devices helpful in managing their bladder dysfunction.
Time frame: through study completion - an average of 3 months
We will compare usability outcomes between post-partum women and general women groups
Time frame: through study completion, an average of 3 months
Paired t-test for pre-post standard pelvic health physical therapy, comparing general and postpartum groups. Pairwise comparisons may be performed between specific outcomes of interest.
Time frame: at study completion - an average of 3 months, post baseline
Health IT Usability Evaluation Model (Health-ITUEM) survey to evaluate bladder wearable devices (1-5 scale) - assessing patient perceived effectiveness. Investigators will compare measures between groups (general, post-partum and post-prostatectomy patients) to evaluate differences in perceived device helpfulness in managing bladder dysfunction.
Time frame: Through study completion - an average of 1 year
Clinicians will be asked to rate how much they like the devices to incorporate into treatment for their patients (1-5 scale)
Time frame: Through study completion - an average of 3 months
Patients will be asked to rate perceived ease of use, perceived usefulness of the bladder devices in managing their symptoms (scale of 1-5)
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Acronym: ClinicWeB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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