Postpartum Bladder Dysfunction, Post-prostatectomy Bladder Dysfunction, Bladder Dysfunction
Conditions
Keywords
bladder dysfunction, pelvic health physical therapy, wearables
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.
Interventions
OTHERDFree Non-Invasive Bladder Ultrasound
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.
OTHERPerifit Kegel Exerciser
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.
OTHERExit interview
All participants will be asked to complete modified Health IT Usability Evaluation Model (Health-ITUEM) surveys, to evaluate bladder wearable devices in these populations
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison between in clinic and wearable post-void-residual | 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. |
| 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 wearables | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate utility of in-clinic and wearable derived post-void-residual | 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. |
| Usability (clinicians) | 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 |
| effectiveness (patient) | 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. |
| Post-partum vs general women - device usability | through study completion - an average of 3 months | We will compare usability outcomes between post-partum women and general women groups |
| Evaluate differences between utility of in-clinic and wearable derived post-void-residual, between general and postpartum women | 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. |
| effectiveness (patient groups) | 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. |
Countries
United States
Contacts
CONTACTValerie J Block, PT, DPTSc
PRINCIPAL_INVESTIGATORValerie Block, PT, DPTSc
University of California, San Francisco
Outcome results
None listed