An exploration of facilitators and barriers to patient navigator core functions with breast cancer patients: Implications for the development of a human-centered mHealth app.

Objectives: To understand the barriers to core functions and workflow among patient navigators (PN) who navigate people diagnosed with breast cancer (BC). To identify how a mobile health (mHealth) app could assist PNs in providing care to BC patients. Methods: This qualitative research study used purposive sampling to recruit stakeholders (N = 33) from January to August 2021. We conducted individual semi-structured interviews with PNs (n = 11), oncology care providers (n = 12), and BC patients (n = 10). We used conventional content analysis to analyze the interview data. Results: Participants identified the following sociotechnical systems barriers in PN workflows that negatively impact BC patient care: 1) resources, 2) insurance coverage, 3) communication challenges, and 4) impact of logistical tasks. Participants identified the user experience, app features, and interoperability customizations to enhance PNs' provision of patient care as important design elements to include in a mHealth app. Conclusion: Feedback from stakeholders provided valuable insights into key design considerations, functions, and content areas for developing a mHealth app for PN use in BC care delivery. Innovation: This is one of the first studies to incorporate the human-centered design and sociotechnical systems frameworks to understand barriers to PN workflow and provision of BC patient care across the cancer care continuum.

Influence of visual and auditory cues about bladder volume on real-time filling sensation in healthy volunteers.

Auditory/visual (A/V) cues can trigger urgency in some individuals with overactive bladder (OAB), and patient-reported bladder sensation can be characterized during non-invasive oral hydration studies. The aim of this investigation was to test the hypothesis that A/V cues of bladder volume can alter patient-perceived bladder sensation during hydration studies. Healthy volunteers without urinary symptoms based on ICIq-OAB survey scores were recruited for an oral hydration study where they completed two fill/void cycles. The study was repeated twice, one week apart. Throughout bladder filling, participants reported real-time sensation (0-100%) using a Sensation Meter, and bladder volumes were measured at 5 min intervals with both 3D ultrasound and BladderScan®. Participants were divided into a Cues(+) group that was allowed to view their ultrasound images and hear volume measurements of the BladderScan® every 5 min and a Cues(-) group that was not exposed to these A/V cues. The A/V Cues(+) group had 10 participants (5 women and 5 men) and the Cues(-) group had 10 participants (7 women and 3 men). During the second visit, the Cues(+) group demonstrated decreased sensation compared to the Cues(-) group in the slower first fill, but not the faster second fill. The results of this study demonstrate that A/V cues about bladder volume can acutely alter sensation during hydration studies in healthy individuals with normal bladder function.

Irregular bladder shapes identified in women with overactive bladder: an ultrasound nomogram.

In this study, an ultrasound-based bladder shape nomogram was developed using data from women without overactive bladder (OAB) and tested in women with OAB to identify irregular bladder shapes. The goal was development of a nomogram that can ultimately be used for non-invasive identification of a bladder shape-associated OAB phenotype. Transabdominal 3-dimensional (3D) bladder ultrasound images were collected at 1-minute intervals during urodynamics studies and at 5-10-minute intervals during oral hydration studies. These prospective studies enrolled women with and without OAB based on International Consultation on Incontinence questionnaire on OAB (ICIq-OAB) question 5a (OAB 5a≥2, without OAB 5a<2). Bladder perimeters were manually traced and refined using GE 4D-View software. Nomograms for the transverse, sagittal and coronal perimeter-volume relationships were developed for women without OAB. A power model was used to approximate upper and lower nomogram bounds with 95% confidence intervals. Nomograms were tested using data from women with OAB, and each participant was classified as having an irregular bladder shape based on the number of perimeter values outside the nomogram bounds. Nomograms were developed using 533 images from 27 women without OAB (14 from urodynamics and 13 from hydration studies) and were tested using 264 images from 24 women with OAB (16 urodynamics and 8 hydration). The sagittal perimeter nomogram provided the best results, with irregular sagittal perimeters identified in 6/24 (25%) women with OAB and 0/27 (0%) without OAB. An irregular sagittal perimeter was significantly associated with OAB (P<0.05). Ultrasound-based nomograms may enable feasible, non-invasive identification of a subgroup of women with bladder shape-associated OAB.

Comparison of Sensation Event Descriptors in Participants with Overactive and Normal Bladders during Non-Invasive Hydration Studies.

PURPOSE: Despite the importance of alterations in bladder sensation, objective metrics to characterize sensation outside of urodynamics remain limited. A real-time sensation meter enables recording of sensation event descriptors throughout filling. The purpose of this study was to evaluate the differences in sensation event descriptor patterns between normal participants and those with OAB. METHODS: Normal and OAB participants were enrolled from responses to the ICIq-OAB survey question on urgency (Q5a: 0 vs. ≥ 3). Real-time bladder sensation on a 0%-100% scale was recorded on a validated tablet sensation meter throughout two fill-void cycles. The first and second fills were considered "slow" and "fast" respectively. After each sensation meter change (sensation event), a pop-up screen asked participants to characterize sensation with one or more of these descriptors: "tense," "pressure," "tingling," "painful," and/or "other." Oral hydration was achieved by rapid consumption of 2L G2® Gatorade. RESULTS: Data from 29 participants (12 normal/17 OAB) were analyzed. The rate of filling from bladder volume and fill duration, was greater for the fast fill in both groups. In the slow fill, "tingling" (64 ± 3% OAB vs. 77 ± 3% normal, p=0.008) and "tense" (78 ± 3% OAB vs. 94 ± 1% normal, p<0.001) occurred at lower sensations in OAB participants. CONCLUSION: During only the slow fill, OAB individuals experience the sensation descriptors of "tingling" and "tense" at earlier sensations than normal individuals. Therefore, this non-invasive method to evaluate real-time sensation descriptors during filling may identify important sensation patterns and improve understanding and phenotyping of OAB.

Use of Ultrasound Urodynamics to Identify Differences in Bladder Shape Between Individuals With and Without Overactive Bladder.

OBJECTIVES: The objective of this study was to identify differences in bladder shape changes between individuals with overactive bladder (OAB) and unaffected individuals during ultrasound urodynamics. METHODS: A prospective urodynamic study was performed with concurrent transabdominal ultrasound (ultrasound urodynamics) on individuals with and without OAB based on validated International Consultation on Incontinence Questionnaire - OAB survey scores. Three-dimensional ultrasound images were acquired at 1-minute increments during filling and used to measure bladder diameters in the height, width, and depth orientations. The engineering strain for each diameter was compared between participants with OAB and controls during urodynamic filling. The height-to-width ratio at capacity was used to determine if individuals were shape outliers. RESULTS: A total of 22 subjects were enrolled, including 11 with OAB and 11 without OAB. During urodynamic filling in both groups, the greatest degree of geometric strain was found in the height orientation, indicating that bladders generally fill in a craniocaudal shape. The mean ± SD height-to-width ratio of the control group was 1.06 ± 0.12 yielding a 95% confidence interval of 0.82 to 1.30. Five (45.5%) of 11 OAB subjects had height-to-width ratios outside this interval as compared with none of the control subjects, identifying a potential shape-mediated subgroup of OAB. CONCLUSIONS: Three-dimensional ultrasound urodynamics can be used to identify differences in bladder shape comparing individuals with and without OAB. This method may be used to identify a subset of OAB patients with abnormal bladder shapes which may play a role in the pathophysiology of their OAB symptoms.

Bladder volume correction factors measured with 3D ultrasound and BladderScan.

INTRODUCTION: The aim of this study was to investigate conventional 3D ultrasound and portable BladderScan volume measurements and implement correction factors to ensure accurate volume metrics. MATERIALS AND METHODS: Healthy participants without urinary urgency were recruited for a prospective hydration study in which three consecutive voids were analyzed for two separate visits. Just before and after voiding, 3D ultrasound and BladderScan volumes were measured. Estimated voided volumes were calculated as the volume immediately prior to void minus any post void residual and were compared to actual voided volumes measured using a graduated container. Percent errors were calculated, and an algebraic method was implemented to create correction factors for 3D ultrasound and BladderScan. RESULTS: Sixteen individuals completed the study, and six voids were recorded for each participant. A total of 96 volume measurements ranging from 0 mL to 1050 mL with an average of 394 +/- 26 mL were analyzed. Both 3D ultrasound and BladderScan significantly underestimated voided volumes with averages of 296 +/- 22 and 362 +/- 27, respectively. Average percent error for the 3D ultrasound group was 30.1% (pre-correction) and 20.7% (post-correction) (p < 0.01) and 22.4% (pre-correction) and 21.8% (post-correction) for the BladderScan group (p = 0.20). The voided volume correction factors for 3D ultrasound and BladderScan were 1.30 and 1.06, respectively. CONCLUSION: BladderScan and 3D ultrasound typically underestimate voided volumes. Correction factors enabled more accurate measurements of voided volumes for both 3D ultrasound and BladderScan. Accurate volume measurements will be valuable for the development of non-invasive urodynamics techniques.

Validation of a real-time bladder sensation meter during oral hydration in healthy adults: Repeatability and effects of fill rate and ultrasound probe pressure.

OBJECTIVES: A non-invasive protocol was previously developed using three-dimensional ultrasound and a sensation meter to characterize real-time bladder sensation. This study the protocol by measuring the effects of fill rateand ultrasound probe pressure during oral hydration. METHODS: Healthy volunteers with no urinary symptoms (based on International Consultation on Incontinence Questionnaire on Overactive Bladder surveys) were recruited into an oral hydration study. Throughout two complete fill-void cycles, participants drank 2 L Gatorade G2 (The Gatorade Company, Inc., Chicago, Illinois) and used a touch-screen sensation meter to record real-time bladder sensation (0%-100%). The study was repeated three times, once per week (Visits A, B, and C). In Visits A and B, ultrasound was used to measure bladder volume every 5 minutes. Ultrasound was not used in Visit C except at 100% capacity. Volume data from Visit B were used to estimate volumes throughout the fills in Visit C. Sensation-capacity curves were generated for each fill for comparative analysis. RESULTS: Ten participants completed three visits (60 total fills). Increased fill rate led to decreased sensation throughout filling, andultrasound probe pressure led to increased sensation. Participants reported higher sensation at low volumes during Fill 1 of Visit A before training with the sensation meter. Sensation curves with intermittent ultrasound showed repeatability for Fill 2 in Visits A and B. Fill rate and ultrasound probe pressure affect real-time bladder sensation during oral hydration. CONCLUSIONS: This study demonstrated repeatability of real-time bladder sensation during a two-fill oral hydration protocol with ultrasound.

An innovative, non-invasive sensation meter allows for a more comprehensive understanding of bladder sensation events: A prospective study in participants with normal bladder function.

AIMS: There is currently no standardized method of characterizing changes in bladder sensation during bladder filling outside of the urodynamics laboratory. The purpose of this investigation was to characterize real-time bladder sensation events using a sensation meter during oral hydration in individuals with normal bladder function. METHODS: Participants enrolled in an accelerated hydration study drank 2 L Gatorade-G2® and utilized a sensation meter to record real-time bladder sensation (0-100%), verbal sensory thresholds, and sensation descriptors of "tense," "pressure," "tingling," "painful," and "other" for two consecutive fill-void cycles. RESULTS: Data from 21 participants (12 females/9 males) were obtained and demonstrated an average of 8-9 sensation events (significant changes in sensation) per fill with no differences in the total number of sensation events and volume between sensation events (fill 1 vs fill 2). An increased number of sensation events occurred at higher capacity quartiles. Event descriptors of "pressure" and "tingling" were the most commonly chosen descriptors in both fills. CONCLUSIONS: The innovative sensation meter includes the sensation event descriptors of "tense," "tingling," "pressure," and "painful," to enable a more comprehensive understanding of bladder sensation as well as real-time identification, quantification, and characterization of sensation events. The study demonstrates 8-9 events per fill, acceleration of sensation during filling, and unique sensation event descriptor patterns. This technology may be helpful in the identification of novel sensation patterns associated with overactive bladder (OAB) and aging.