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

February 27, 2026 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco Weill Institute for Neurosciences
        • Contact:
        • Principal Investigator:
          • Valerie Block, PT, DPTSc
        • Sub-Investigator:
          • Jordan E LaBrec, PT, DPT
        • Sub-Investigator:
          • Jennifer R Kinder, PT, DPTSc
        • Sub-Investigator:
          • Leah McIntyre, PT, DPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Men post-prostatectomy with bladder dysfunction
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: 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
Postpartum women with bladder dysfunction
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: 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
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.
Women with bladder dysfunction
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: 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
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.
Clinicians
Clinicians will be interviewed at the completion of the study to assess utility of wearables for the bladder in clinical care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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)
through study completion, an average of 3 months
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
through study completion, an average of 3 month
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.
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate utility of in-clinic and wearable derived post-void-residual
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.
through study completion, an average of 3 months
Usability (clinicians)
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
at study completion - an average of 1 year
effectiveness (patient)
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.
at study completion - an average of 3 months post baseline
Post-partum vs general women - device usability
Time Frame: through study completion - an average of 3 months
We will compare usability outcomes between post-partum women and general women groups
through study completion - an average of 3 months
Evaluate differences between utility of in-clinic and wearable derived post-void-residual, between general and postpartum women
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.
through study completion, an average of 3 months
effectiveness (patient groups)
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.
at study completion - an average of 3 months, post baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likability: clinicians
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)
Through study completion - an average of 1 year
Overall satisfaction
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)
Through study completion - an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Valerie Block, PT, DPTSc, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-41945
  • 137241F (Other Grant/Funding Number: UCSF Clinical & Translational Science Institute (CTSI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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