Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 137241F | Other Grant/Funding Number | UCSF Clinical & Translational Science Institute (CTSI) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men post-prostatectomy with bladder dysfunction |
| ||
| Postpartum women with bladder dysfunction |
| ||
| Women with bladder dysfunction |
| ||
| Clinicians | Clinicians will be interviewed at the completion of the study to assess utility of wearables for the bladder in clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFree Non-Invasive Bladder Ultrasound | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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 | 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. | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Likability: clinicians | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients seen at the University of California for pelvic health physical therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie J Block, PT, DPTSc | Contact | ‪(510) 473-7514‬ | valerie.block@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Valerie Block, PT, DPTSc | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Weill Institute for Neurosciences | Recruiting | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | 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 | ||
| Background | 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 | ||
| Background | 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 | ||
| 9491869 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Perifit Kegel Exerciser | Other | 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 | All participants will be asked to complete modified Health IT Usability Evaluation Model (Health-ITUEM) surveys, to evaluate bladder wearable devices in these populations |
|
| 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 |
| 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. | 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 | 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 | 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) | 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 |
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 |
| Background |
| 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. |
| 35461057 | Background | 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. |
| 33387862 | Background | 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. |
| 27896433 | Background | 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. |
| 30874777 | Background | 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. |
| 39435303 | Background | 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. |