NCT07451106 · University of California, San Francisco
Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics
(ClinicWeB)
What this study is about
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.
View original scientific description
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
OTHER
DFree 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.
OTHER
Perifit 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.
OTHER
Exit 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
Primary outcome measures
Comparison between in clinic and wearable post-void-residual
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.
Bladder wearables - usefulness (patient groups)
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)
Bladder wearables - usefulness (clinician)
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
Feasibility of deploying bladder wearables
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations