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Postpartum Bladder DysfunctionClinicWeBNCT07451106

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

An observational study of Postpartum Bladder Dysfunction and Post-prostatectomy Bladder Dysfunction, run by University of California, San Francisco at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DFree Non-Invasive Bladder Ultrasound, Perifit Kegel Exerciser and Exit interview
How many people
25 participants
Where
1 siteUnited States
Study dates
11 Jul 2024to Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • University of California San Francisco Weill Institute for Neurosciences

    San Francisco, California, 94158

Other trials in United States

About this study

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.

Being tested
DFree Non-Invasive Bladder Ultrasound, Perifit Kegel Exerciser, Exit interview
Keywords
bladder dysfunction, pelvic health physical therapy, wearables

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DFree Non-Invasive Bladder UltrasoundOther

    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 ExerciserOther

    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 interviewOther

    All participants will be asked to complete modified Health IT Usability Evaluation Model (Health-ITUEM) surveys, to evaluate bladder wearable devices in these populations

Study groups in NCT07451106
Study groupRoleWhat they receive
Men post-prostatectomy with bladder dysfunctionNot described
Receives: Other: DFree Non-Invasive Bladder Ultrasound; Other: Exit interview
Postpartum women with bladder dysfunctionNot described
Receives: Other: DFree Non-Invasive Bladder Ultrasound; Other: Perifit Kegel Exerciser; Other: Exit interview
Women with bladder dysfunctionNot described
Receives: Other: DFree Non-Invasive Bladder Ultrasound; Other: Perifit Kegel Exerciser; Other: Exit interview
CliniciansClinicians will be interviewed at the completion of the study to assess utility of wearables for the bladder in clinical care
Receives: Other: Exit interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline

  2. 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)

    Measured: through study completion, an average of 3 months

  3. 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

    Measured: through study completion, an average of 3 month

  4. 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.

    Measured: through study completion, an average of 3 months

Secondary outcomes (6)
  1. 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.

    Measured: through study completion, an average of 3 months

  2. 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

    Measured: at study completion - an average of 1 year

  3. 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.

    Measured: at study completion - an average of 3 months post baseline

  4. Post-partum vs general women - device usability

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

    Measured: through study completion - an average of 3 months

  5. Evaluate differences between utility of in-clinic and wearable derived post-void-residual, between general and postpartum women

    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.

    Measured: through study completion, an average of 3 months

  6. effectiveness (patient groups)

    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.

    Measured: at study completion - an average of 3 months, post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start11 Jul 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451106
Sponsor's protocol ID
24-41945
Other IDs
137241F
Acronym
ClinicWeB
Status last verified
Sep 2026
First submitted
23 Feb 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Block VJ, R Henry, B Cree, J Gelfand, Bove R. The Bladder Control Scale Correlates More Robustly with Ambulatory Disability than the Bladder Functional System Score SAGE Publications Ltd STM; 2022:692-945.

  • Gopal A, Block V, Gelfand J, et al. Gaps in characterization of bladder dysfunction in clinical care and research. Poster presented at: MSVirtual2020: ECTRIMS-ACTRIMS joint conference; September 11-13, 2020 2020; Virtual. www.msvirtual2020.org

  • Kinder J, Cheuy V, Davenport TE. Integrating Pelvic Health and Orthopedic Programs to Treat Incontinence at the Community Level for Female Runners: A Pilot Study. The Journal of Women's & Pelvic Health Physical Therapy . 2023;47(3):191-202. doi:10.1097/jwh.0000000000000271

  • Block VJ, Suskind AM, Guo C-Y, Poole S, Cutter G, Bove R. WeB: A Pilot Study of WEarables for Bladder Monitoring in People with Multiple Sclerosis. Neurology online supplement; 2024

  • Sampselle CM, Miller JM, Mims BL, Delancey JO, Ashton-Miller JA, Antonakos CL. Effect of pelvic muscle exercise on transient incontinence during pregnancy and after birth. Obstet Gynecol. 1998 Mar;91(3):406-12. doi: 10.1016/s0029-7844(97)00672-8.

    PubMed 9491869
  • Kaplan TB, Gopal A, Block VJ, Suskind AM, Zhao C, Polgar-Turcsanyi M, Saraceno TJ, Gomez R, Santaniello A, Consortium S, Ayoubi NE, Cree BAC, Hauser SL, Weiner H, Chitnis T, Khoury S, Bove R. Challenges to Longitudinal Characterization of Lower Urinary Tract Dysfunction in Multiple Sclerosis. Mult Scler Relat Disord. 2022 Jun;62:103793. doi: 10.1016/j.msard.2022.103793. Epub 2022 Apr 11.

    PubMed 35461057
  • Block VJ, Mestas O, Anderson A, Singh J, Wylie L, Guo CY, Green AJ, Gelfand JM, Bove R. Underutilization of physical therapy for symptomatic women with MS during and following pregnancy. Mult Scler Relat Disord. 2021 Feb;48:102703. doi: 10.1016/j.msard.2020.102703. Epub 2020 Dec 19.

    PubMed 33387862
  • Block VJ, Lizee A, Crabtree-Hartman E, Bevan CJ, Graves JS, Bove R, Green AJ, Nourbakhsh B, Tremblay M, Gourraud PA, Ng MY, Pletcher MJ, Olgin JE, Marcus GM, Allen DD, Cree BA, Gelfand JM. Continuous daily assessment of multiple sclerosis disability using remote step count monitoring. J Neurol. 2017 Feb;264(2):316-326. doi: 10.1007/s00415-016-8334-6. Epub 2016 Nov 28.

    PubMed 27896433
  • Block VJ, Bove R, Zhao C, Garcha P, Graves J, Romeo AR, Green AJ, Allen DD, Hollenbach JA, Olgin JE, Marcus GM, Pletcher MJ, Cree BAC, Gelfand JM. Association of Continuous Assessment of Step Count by Remote Monitoring With Disability Progression Among Adults With Multiple Sclerosis. JAMA Netw Open. 2019 Mar 1;2(3):e190570. doi: 10.1001/jamanetworkopen.2019.0570.

    PubMed 30874777
  • Block VJ, McIntyre Nee Wylie L, Sisodia N, Van Kuiken ME, Suskind AM, Bove R. Wearables for the Bladder: Stakeholder Perspectives on Moving Multiple Sclerosis Bladder Dysfunction Interventions Into the 21st Century. Int J MS Care. 2024 Oct 21;26(Q4):290-301. doi: 10.7224/1537-2073.2023-108. eCollection 2024 Oct.

    PubMed 39435303

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Bladder Dysfunction and Post-prostatectomy Bladder Dysfunction, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison between in clinic and wearable post-void-residual (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07451106, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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