Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics

ConditionsPostpartum Bladder Dysfunction Post-prostatectomy Bladder Dysfunction Bladder Dysfunction

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of California, San Francisco

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients seen at the University of California for pelvic health physical therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

DFree Non-Invasive Bladder Ultrasound
Other intervention
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.
Perifit Kegel Exerciser
Other intervention
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.
Exit interview
Other intervention
All participants will be asked to complete modified Health IT Usability Evaluation Model (Health-ITUEM) surveys, to evaluate bladder wearable devices in these populations

Treatment groups

25 Participants

are divided into 4 treatment groups

Group A: Men post-prostatectomy with bladder dysfunction2 interventions

Group B: Postpartum women with bladder dysfunction3 interventions

Group C: Women with bladder dysfunction3 interventions

Group D: Clinicians1 intervention

Trial outcomes

Primary outcomes

Comparison between in clinic and wearable post-void-residual

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

baseline

Bladder wearables - usefulness (patient groups)

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 months

Bladder wearables - usefulness (clinician)

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 month

Feasibility of deploying bladder wearables

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

Secondary outcomes

Evaluate utility of in-clinic and wearable derived post-void-residual

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

through study completion, an average of 3 months

Usability (clinicians)

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 1 year

effectiveness (patient)

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

at study completion - an average of 3 months post baseline

Post-partum vs general women - device usability

We will compare usability outcomes between post-partum women and general women groups

Time frame

through study completion - an average of 3 months

Other outcomes

Likability: clinicians

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 1 year

Overall satisfaction

Patients will be asked to rate perceived ease of use, perceived usefulness of the bladder devices in managing their symptoms (scale of 1-5)

Time frame

Through study completion - an average of 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov

Apply now