Wearables for the Bladder: Stakeholder Perspectives on Moving Multiple Sclerosis Bladder Dysfunction Interventions Into the 21st Century

A mbulatory disability is 1 of the most prominent and visible symptoms in multiple sclerosis (MS) and serves as the foundation for many rating scales, including the Expanded Disability Status Scale (EDSS)¹  and the Timed 25-Foot Walk.²  However, other less visible symptoms, including bladder dysfunction (BD), significantly impact people with MS. BD typically emerges within a decade of diagnosis and progressively worsens over time, and is distinct from acute relapse-related BD.^3,4  BD may encompass symptoms such as both frequent and urgent urination, frequent nighttime urination (nocturia), and incomplete bladder emptying, which can also lead to significant urinary incontinence. It not only impacts primary functioning but also leads to secondary consequences, such as reduced physical activity, increased fatigue (presumably from interrupted sleep if nocturia is present), physical deconditioning, and reduced quality of life (QOL).^5-8  BD poses health and safety risks, including recurrent urinary tract infections, falls,^4,9  and significant health care costs, yet it remains largely underresearched.^10,11 

Barriers to the prompt detection of BD include a lack of time among clinicians, discomfort in managing BD if it was not emphasized during neurological training, and the level of detail in patient reporting. Patients often perceive BD as embarrassing, sensitive, or tied to aging, leading to the belief that nothing can be done to improve or maintain the symptoms. This can lead to a lack of communication regarding available BD treatment options.^12,13  Frequently, patients only bring up bladder issues with their clinician once symptoms have progressed to a point where invasive treatments like surgery are the only viable option.⁴  Identifying BD early would allow for noninvasive, prevention-based treatments, such as pelvic floor physical therapy (PT),^14,15  to be effective.

The integration of neurotechnology and patient-reported outcomes (PROs) for remote monitoring would represent a substantial improvement in monitoring and treating BD. The current evaluation of BD severity relies on intrusive in-clinic assessments (eg, post-void residuals, urodynamic testing) and extended monitoring predominantly hinges on PROs. Although PROs are critical for documenting the patient experience, they may be less accurate due to recollection inconsistency and variations in deficit perception. To ensure successful adoption of novel technologies in clinical care and research, it is crucial to involve users, including clinicians and patients, in the development process and device selection. Therefore, our overall objective was to engage stakeholders in a human-centered design (HCD) process to develop a wearables for the bladder (WeB) kit with the goal of enhancing the evaluation, monitoring, and treatment of BD in people with MS. Subsequently, the WeB kit will be validated against gold-standard evaluation metrics, and its utility and effectiveness to improve the intensity, duration, and frequency of pelvic floor PT interventions will be tested in a clinical trial.

The study was based on the theories and stages of HCD, prioritizing the usability and requirements of a tool’s intended users (in this case, patients and clinicians). The development process consisted of extensive stakeholder engagement and evaluation of tool usability utilizing the Health Information Technology Usability Evaluation Model (Health-ITUEM) and Scoring (Health ITUES).¹⁶ 

The HCD model is a problem-solving approach that places individual users at the core of the development process, creating solutions customized to their specific needs.¹⁷  Although wearable technologies for bladder monitoring are commercially available, to our knowledge, they have not been tested individually or in combination in people with MS. To increase the likelihood that the devices chosen would be used and successful, each round of device selection and scoring used the Health-ITUEM and ITUES, including both subjective and objective outcomes. The subjective outcomes focused on satisfaction, specifically perceived ease of use and perceived usefulness of each device evaluated. In addition, variables associated with the potential WeB kit tools were considered, including their alignment with HCD principles and their capacity to engage patients.¹⁸  These variables included usefulness, ease of use/learnability, effectiveness, and how much participants liked the device overall. The devices were tested by the stakeholders, both clinicians and patients, in their homes.

Four virtual stakeholder meetings were held between April 2021 and May 2022. To accommodate COVID-19 restrictions and geographical barriers, meetings were conducted via the University of California San Francisco (USCF) Zoom video platform (FIGURE 1; TABLE S1).

Clinician stakeholders were contacted either by email or in person and invited to participate. Patients who had previously granted research participation consent, or who had known BD, were invited via secure email communication. The UCSF institutional review board (IRB #21-33653) approved all study activities and informed consent was obtained from all participants. No compensation was provided for participation.

The clinicians were a neuro-urologist (AMS), an MS neurologist (RB), a pelvic floor physical therapist (LM), an MS remote monitoring expert and physical therapist (VJB), and an international women’s health expert (Doreen McClurg, PhD). The patients were 3 women and 1 man with MS who had varying degrees of BD (all with documented bladder-related issues in their electronic medical records). They had different levels of technical literacy and were aged between 36 and 68 years.

TABLE 1 summarizes the initial devices selected for evaluation and assessment in Round 1, encompassing their respective inclusion/exclusion during stages of the evaluation process. A summary of the devices evaluated in each round, culminating in the selection of the devices for the pilot studies, is presented in FIGURE S1.

On a 10-point scale, the DFree, Perifit, and Innovo devices scored a 7 or above, were available in the United States for purchase at the time of the study, and were chosen for testing by stakeholders (full details in TABLE S2). The Carin Pro was not in stock at the time of the study. Notably, although the Uromonitor, eCoin, and BlueWind RENOVA (since renamed Revi) were thought to be promising, they were still under investigation and not available for commercial use at the time of the study.

The main qualitative feedback from the stakeholders regarding each device from Round 1, including the anticipated benefits, disadvantages, and key features for users (patients and clinicians) is summarized in TABLE S3.

Overall, the devices were worn by the 5 clinicians and 4 patients for an average of 2 days at home.

DFree: Four patients and 3 clinicians liked the device and rated it as useful for “visualizing the changes in bladder fullness over time” (7.4/10). More than 50% found it useful for helping to focus on other activities rather than planning restroom breaks, preventing accidents, and managing BD in general (TABLE S4).

Notably, the DFree was updated during the stakeholder evaluation process from an ultrasound device with an external wire connecting it to a clip-on Bluetooth device (that was hard to conceal) to a smaller, more discreet device. Participants had the opportunity to retest the newer model and this increased the overall score from 6.8 to 9.0 of 10.

Perifit: A smaller group of stakeholders (4 individuals) assessed the tool in person, as opposed to the 8 who evaluated the DFree device. Several individuals opted not to use it because it is an intravaginal device, citing personal preferences, while the male stakeholder was unable to test it. The Perifit scored high on ease of use and treatment utility. The higher average score for “helping to focus attention on activities of daily living, rather than managing BD” was derived from the discussions, indicating that the score was influenced by the perceived potential gains that the Perifit could offer if included in a treatment program.

Innovo: The device received a likability score of 0 from the stakeholders. A particular concern was about electric shocks near genitalia. Overall, it received a low recommendation score for use in the WeB kit.

During stakeholder meetings, it became evident that clinicians and patients had substantial differences in their perceptions of the tools. For instance, clinicians substantially revised initially low usability scores for the DFree in response to patient recognition of the tool’s potential benefits. One striking example was the enthusiasm among patients for the potential advantages of using these devices to monitor urine volume, in contrast to the conventional practice of adhering to fixed voiding schedules every 3 hours (timed voiding). This shift in perspective was primarily motivated by the potential to enhance personal freedom and mobility, especially outside of the home. Similarly, the gaming feature of the Perifit Kegel exerciser, initially perceived by clinicians as potentially juvenile, proved to be visually effective and highly engaging when tested by patients.

It’s worth noting that, at this point in the study, we had to limit inclusion to female participants due to the specific mechanics of certain devices included in our kit. However, our commitment to inclusivity remains strong, and exploration of devices suitable for male participants to expand the reach and impact of our WeB kit is ongoing.

For the pilot WeB kit, the DFree and the Perifit were chosen for remote symptom monitoring. For the DFree, experts suggested validation against in-clinic post-void residual testing and conventional measures (ie, 3-day bladder diary) of bladder function. Stakeholders proposed comparing scores on a Perifit game that evaluates muscle strength with Manual Muscle Testing scores. This idea was shelved for future studies as additional funding would be needed for the single-user devices.

The DFree and Perifit were also both chosen as tools to include in the pelvic floor physical therapy (PFPT) pilot WeB kit, as each device offers unique potential benefits and recommended usage strategies. The Perifit scored as the most useful WeB device to augment the intensity, duration, and frequency treatment of PFPT objectives. The short, predefined games, the real-time feedback (closed loop), and the prescription suitability were highlighted as benefits by the clinician stakeholders. The patient stakeholders also rated the device as potentially useful to maintain exercise programs between PFPT sessions, citing potential benefits to improving adherence to the overall PFPT home exercise program.

The DFree was also chosen as a potential adjunct to PFPT training. Stakeholders proposed that participants could use the devices to monitor and suppress urges when experiencing strong sensations of urgency, helping to correlate these sensations with visualized (biofeedback) bladder volume. Additionally, stakeholders highlighted the opportunity for bladder training with guidance from pelvic floor physical therapists, suggesting that participants set a specific threshold volume for voiding, which could adapt as they receive training, akin to the principles of timed voiding in standard care, but with greater autonomy and personalization.

To assess any interactions or associations with MS symptom-specific questionnaires, PROs were selected as a group (from list of the most commonly used questionaries encompassing BD and other MS symptoms from the literature), combining urology and pelvic floor PT expertise. These are detailed in TABLE S5.

Anonymous credentials would be assigned to all devices in the WeB kit, and weekly (or biweekly) reports would be available for the therapist and research team to review. This would enable a prompt and closed-loop adjustment of the home program intervention and detection of adherence in an objective manner. Stakeholders recommended 3 to 5 days of DFree use a month for the monitoring phase (3 months), and as much as possible, with a set minimum threshold (1-3 days a week), for the intervention pilot phase. It was noted by all stakeholders that duration and frequency should be PFPT recommended after the initial evaluation visit. Patient stakeholders recommended training videos, not just written instructions, on the use, maintenance, and protocol for each WeB device.

Our pilot study findings underscore the critical importance of inclusive stakeholder engagement in choosing devices to monitor and potentially treat bladder dysfunction, a domain that is particularly sensitive, personal, and understudied.¹¹  The insights gained from clinicians and patients shaped the selection of devices that not only met users’ preferences but also had the potential for widespread adoption. Without this invaluable input, our approach and outcomes might have been entirely different.

The difference in the perceptions of clinicians and patients regarding device utility was significant in this study. For instance, a device considered least useful by experts received high patient ratings, emphasizing the importance of including patient perspectives in device development for personal domains like pelvic function and BD. Moreover, there was a divergence in views regarding the optimal timing and duration of device usage. This reflects the challenge of balancing data acquisition with patient burden. Ultimately, we agreed on a suitable monitoring duration of 5 days per month for the DFree in this pilot study. The meetings also revealed a debate on device usage frequency throughout the study, highlighting the need for ongoing collaboration between health care professionals and patients to align monitoring and treatment protocols with patient preferences.

Progressing through the pilot study and beyond, it is vital that feedback from patients continues to shape our research. The ongoing input is valuable for collaborating with device manufacturers to enhance the suitability of BD devices for individuals with neurological disorders. Remote monitoring of functional domains in people with MS is a burgeoning field, with a multitude of research papers regarding validation and cross-sectional outcomes (in particular, for physical activity and walking in MS). However, it is essential to continue the process of transitioning WeB devices from their primary role as monitoring tools to their integration into rehabilitation interventions. In the case of BD, incorporating devices with traditional PFPT approaches signifies a move toward not only more objective, continuous, and remote monitoring but also actively treating individuals with BD.

The study had several limitations. It is important to acknowledge that larger-scale studies involving more diverse stakeholder cohorts are needed to further explore and substantiate these initial findings. Such studies will provide a more comprehensive understanding of the potential benefits and limitations of these devices in a broader context and contribute to the ongoing improvement of BD management strategies for individuals with MS. This version of the WeB kit proved to be exclusively for women. Additional research efforts are required to cater to the diverse needs of all sexes and genders in the comprehensive evaluation, monitoring, and management of BD in the context of MS.

After development, the WeB kit will be validated against gold-standard evaluation metrics, and its utility and effectiveness to enhance PFPT outcomes will be tested in a clinical trial. To our knowledge, there are no trials using commercially available, at-home bladder wearables in people with MS, underscoring the innovative potential of the WeB kit to complement existing treatments such as medications, PFPT, and surgical or Botox (onabotulinumtoxinA) procedures. If the results of the pilot studies are clinically meaningful, the WeB kit may emerge as a promising solution to address critical gaps in our ability to measure and manage BD in people with MS. By potentially reducing the adverse impact of BD on QOL, these devices could significantly improve the overall well-being of individuals with MS.

The authors are grateful for the contributions of Doreen McClurg, PhD. She contributed to the study design and stakeholder engagement as an expert in women’s health in MS. Subsequently she could not be contacted for inclusion as an author of this paper.