Investigating and Designing the Appearance of a Device for Facilitating Pelvic Floor Exercises: A Case Study on Design Sensitivity for Women’s Healthcare Investigating and Designing the Appearance of a Device for Facilitating Pelvic Floor Exercises: A Case Study on Design Sensitivity for Women ’ s Healthcare

Pelvic floor disorder (PFD) refers to a weakened or damaged muscle structure affecting the self-esteem, confidence and social participation of affected women. With appropriate training, the weakened muscles can be strengthened, but for a long-term improvement the women need to be actively engaged in the process. While there exists a range of devices that can intra-vaginally measure pelvic floor activation and help women do their exercises, it is unclear how the appearance of the devices may affect women ’ s willing-ness to use them. We believe that a further understanding around the appearance of these devices may help women feel more comfortable using them, therefore helping them care for their health. We carried out interviews and online questionnaires with women (n:70) who use the devices and clinicians (n:4). We report on identified areas where the appearance of devices is important for women. We present the iterative design process and evaluation of a system aimed at facilitating self-directed pelvic floor management based on this research. We suggest that discrepancies in the responses from participants call for personalisation of the device to meet individual user expectations and increase the design sensitivity when designing for smart devices that help women care for their health.


Introduction
Pelvic floor disorders (PFDs) can affect up to 44% [1] of all women and symptoms like urinary incontinence (UI) can have a significant effect on self-esteem, confidence and social participation [2]. Pelvic floor muscle training (PFMT) is the first-line conservative management programme for women experiencing PFD.
The condition is a significant healthcare concern for the affected women and has a variety of causes such as childbirth and ageing. A recent study showed that even women who do not show any symptoms do not always know how to contract the muscles correctly [3]. Reports suggest that 70% of women are unable to perform correct voluntary PFM contractions and 97% of them showed low PFM strength [3]. PFMT can increase strength and endurance, particularly when coupled with behavioural training [4][5][6].
There are some devices in the market that help women carry out their PFMT. The devices detect the pressure applied by the pelvic floor muscles through an intra-vaginal physical device with pressure sensors that communicate via Bluetooth to a mobile app [7]. Existing devices include the LOOP [8], the SKEA [9], the KGoal [10], the PeriCoach [11], Elvie [12] and the Kegel smart [13]. While the use of these devices has been reported as helpful, their uptake has been slow and there seem to be barriers to their adoption [7]. Currently, there is no literature that reports on how the appearance of the devices may help women feel more comfortable in using them or help them understand its use, particularly in this area where education about its correct use is essential.
There are models that can be used to increase the patient's engagement to therapies. The IMS model recommends three steps: (1) information about the condition and how to adhere, (2) motivation to participate in the training and (3) a strategy to overcome practical treatment barriers to treatment adherence and incorporate the training into a daily routine [14]. We used this model to assess women's experience with PFMT and how they perceive the appearance of devices.

Methods
We analysed online commentary from PFD forums, carried out semi-structured interviews (45 min) and questionnaires (A, 20 min) with health professionals (three pelvic floor physiotherapists and one urogynecologist) and women with self-reported PFD (n:70; New Zealand = 24, USA = 22, UK = 13, Australia = 5, Canada = 4, Taiwan = 1, France = 1), ages 20-69 (median 35). A total of 54 women had children. We asked clinicians to describe the process for prescribing and monitoring PFMT and the main issues they have found for women using PFD devices. We asked women to describe their overall experience of using PFD devices, including how and how often they use them and any issues they have found with them.
We defined a set of design criteria through a thematic analysis of all the data and we used an iterative research-through-design process [15] to arrive to a testable physical device and mobile app. We asked women to watch a 5-min presentation that explained our design concept through video and to answer a second online survey (B, 15 min).

Results
We coded the findings from the literature review, online forums, semi-structured interviews and questionnaires with health professionals and women with self-reported PFD using NVivo ( Figure 1). Below we present a deductive thematic analysis based on the IMS model and the responses from participants.

Female anatomy
A lack of information about female anatomy can be a significant barrier in the process of women carrying out PFMT or using devices. Women often do not understand their own anatomy, are unable to locate genital openings correctly, and may feel unreceptive to looking and touching their own genitals.
For many ladies that area of their body is still quite sort of shameful and unknown and so I take the view that for a lot of women they have not learnt anything about their body anatomically since year 7 science when it was embarrassing to say the words penis and vagina at school. (Clinician 04) I show them what their anatomy is like cause a lot of women have never looked at themselves. They don't know where the muscles areso I point out the hip bone the pelvic bone and the  Even though some clinicians use medical equipment that they rent out to women, one mentioned that sometimes sex toys get already used to relax the pelvic floor: "I buy the devices and then people borrow them off of me -I will give them out." (Clinician 01); "there are some people who actually use vibrators to relax the pelvic floor." (Clinician 02). The women favoured discreteness in form along with ease and simplicity of use. Comments given about the performance of the devices included, "good enough to lessen physical symptoms" and in turn reduce psychological distress. Some disliked their devices being too "clinical" in appearance. However, some women expressed that they did not want their device to appear too much like a sex toy because if features were too strongly associated with it, this would create a sense of psychological awkwardness for the user: "Don't like that it's so clinical, something more shapely [sic] without crossing into sex toy territory would perhaps make it less of an awkward experience." (Participant 04).

Muscle awareness and metaphors
Being able to contract the right muscles is determined by a muscle awareness that the women need to establish [4]. This muscle awareness can be difficult to develop due to the 'hidden location' of the muscles and lack of intrinsic feedback. Clinicians often use metaphors to teach women how to locate and move those muscles: "Going up in the lift… Puddle of watersucking it in…" (Clinician 01).

Stigma and emotional responses
Clinicians pointed out that women can feel uncomfortable using an internal device. Reasons are the location where the device needs to be placed as well as the associated stigma with PFD conditions such as UI and faecal incontinence. Some women say: "Oh I don't like to poke those things inside of me in case I get an infection" (Clinician 01).
It was mentioned that women tend to be hesitant to talk about the condition and that once they have developed a feeling of trust they start opening up and talk about their symptoms: And their GPs had sort of brushed them off. 'Oh, you know, it's just you. You just have to put up with it' you know, they trivialised it to them whereas, it's not trivial." (Clinician 03). Also, "It's just developing trust as well, people trusting you enough to say whatever the problem is, and I think when I realised there were so many people with those issues". (Clinician 01) As expected, more negative feelings than positive tend to be associated with the experience of having a PFD. Words such as "embarrassed" and "frustrated" were commonly used. Negative feelings contribute to the development of stigma as well as perpetuating these feelings when a condition has a stigma attached to it. Some women were worried their children might play with the device if they found it.

Ease of use
Respondents mentioned how some existing devices are difficult to learn to use: The e. investigate the responses of looking medical or like a sex toy (motivation) The app should: f. teach women about their anatomy (information) g. relate to metaphors women or clinicians use to carry out their exercises to facilitate muscle awareness (information) h. present steps for carrying out exercises that use engagement principles from games and psychology (motivation) i. present the exercises in an order and form that allows women to learn the right way of doing exercise and increase intensity (strategy) j. develop a sense of trust through facilitating communication with clinician (motivation).

Design experiments
We developed different prototypes in an iterative process to address the criteria above (Figures 2-10).

Testable design
The app and device we tested through online survey B is part of a system ( Figure 11). The physical device has two parts. The slim top part is insertable and contains the array of sensors that had been developed by our engineering collaborators ( Figure 12). This part has two states: a slim and minimally intimidating form for the insertion and an expanded form to secure the device once inserted that activates through bending the device into place (Figure 8). The wider part contains the electronic components. The app teaches women about their anatomy and  creates an individualised programme based on the initial calibration of the device, which works as an assessment of the condition too.

Assessment of the testable design
Our initial findings suggested that the appearance of a device does not only involve a sense of aesthetics, but it should also communicate important issues for women that included: how   intuitive it is to use, how professionally it will treat women and their condition, how the sensors work and where they should be placed.
Positive feedback included the quantifiable results ("quantifiable results would be incredibly helpful", participant 4), ease of use, and the immediate assessment and feedback that the system offers during training. Some participants requested a colourful appearance while others found the paler colour more appealing. Participants understood the value of  including sensors: "[I like] that it shows how strong the muscles are and if you're using the wrong ones" (participant 6). Other participants liked its discreetness: "I like that it is discrete and quite private, with the training times set to suit the user" (participant 1). A participant was worried about whether the device would sit on her clitoris.

Final design
We used the feedback to define a final iteration of the design ( Figure 13).   Investigating and Designing the Appearance of a Device for Facilitating Pelvic Floor Exercises: A Case Study… http://dx.doi.org/10.5772/intechopen.71128 Figure 12. The physical device we tested with participants.

Discussion
Women who experience PFD are a diverse user group. Depending on the severity of the disorder they can have different symptoms, be from different age groups, experience a significant degree of shame and stigma, and the dimensions of the human vagina can differ significantly. All of these questions the assumption that one device fits all [16].
Women reported different expectations on how such an intimate device should look. User feedback indicates a discrepancy of expectations concerning the visual aesthetic of such an intimate device. There were some women assessing our design who wanted it to look like a medical device while other would prefer it to be more playful and even resemble and be used as a sex toy. We suggest that further research is necessary to investigate the motivations behind these preferences and how designs may address it. Further studies could investigate from a design perspective where form-wise lies the tipping point between clinical device and sex toy; build functional prototypes and test them with women in order to assess the usability and interaction with the device over long-term use.

Conclusion
This paper reports on what factors should influence the physical appearance of an intravaginal device to help women carry out pelvic floor exercises. A review of the literature, interviews and questionnaires with clinicians and women with PFD helped us develop a set of criteria that we used to design a device and app for PFMT. User feedback indicates that there are different expectations about the aesthetics of such an intimate device. This discrepancy in expectations and the fact that the range of disorders and users can differ rather significantly suggest that individualising the device might be an appropriate strategy to address the demands of this diverse user group.