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

Overview

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]
• Bladder wearables - usefulness (patient groups) [Time frame: through study completion, an average of 3 months]
• Bladder wearables - usefulness (clinician) [Time frame: through study completion, an average of 3 month]
• Feasibility of deploying bladder wearables [Time frame: through study completion, an average of 3 months]

Secondary outcome measures (6)

• Evaluate utility of in-clinic and wearable derived post-void-residual [Time frame: through study completion, an average of 3 months]
• Usability (clinicians) [Time frame: at study completion - an average of 1 year]
• effectiveness (patient) [Time frame: 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]
• 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]
• effectiveness (patient groups) [Time frame: at study completion - an average of 3 months, post baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• University of California San Francisco Weill Institute for Neurosciences — San Francisco

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. PMID 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. PMID 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. PMID 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. PMID 27896433

Identifiers

NCT: NCT07451106 · 24-41945 · 137241F

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗