It is well-recognised that pelvic floor muscle (PFM) training can resolve symptoms of stress urinary incontinence for women. Barriers to effective PFM training are incorrect PFM contraction, and low adherence. The World Health Organisation states that digital technology has the potential to enhance health with self-management of care, and there is scope for this to be applied in the area of PFM health. Biofeedback can help women undertake correct PFM contraction, although more research is still required for home use. It is proposed that a mobile application (app), with visual biofeedback, could guide women through a clinically developed exercise programme for home PFM training. 

The aim of this project was to use co-operative design with an iterative framework to attain user feedback and develop a fun and motivating app for women to self-guide PFM training. The project also aimed to ensure the app meets user requirements, conforms to medical device standards (ISO 62366-1 and ISO13485), and follows the Mobile Application Rating Scale (MARS) to create a high-quality health app. Design and development checklists [1], were incorporated into the framework and approach.

This study used human-centered design and qualitative, iterative framework methodologies. This approach focused on engaging a wide range of potential users to create a product that would be relevant within the context of their lives, experiences, and attitudes. The design emphasized both problem-finding and problem-solving, resulting in effective solutions. Focus groups and one-to-one sessions were used to gather information about perceptions and attitudes towards an intra-vaginal biofeedback device (femfit) and to develop its associated mobile app. A flowchart showing the multi-disciplinary iterative design approach for this project is shown in Figure 1.

The femfit is an intra-vaginal pressure sensor array that transmits pressure via Bluetooth to display real time biofeedback on a mobile app [2]. It comprises eight pressure sensors encapsulated in biocompatible silicon. It is flexible and comfortable, so does not obstruct natural anatomical movement during a PFM contraction. The femfit has been manufactured adhering to the ISO13485 quality standard. Women can use the femfit to effectively locate and exercise their PFM, and via an app can self-guide through an evidence-based clinically relevant training programme. 

Four focus groups (2 hours each) and two sets of one-to-one interviews (1 hour each) were held over 18 months. Focus groups were used to gather information about potential users’ perceptions and attitudes towards the app’s development. Recurring statements were identified and summarised to document key themes. Where possible, the same women were used for successive focus groups, to build on their PFM knowledge and app exposure, allowing for iterative design. Topic areas and themes were pre-defined and adapted to each iteration of the app. The focus groups facilitated interaction and discussion about the various aspects of the app, and discussion highlighted potential users’ questions, concerns, and experiences.  Participants were selected as they had some experience of urinary incontinence (UI) – from mild to severe – and the researchers were conscious of creating a permissive and safe space to encourage participants to share their experiences. Farquhar notes that group methods can make an important contribution to sensitive research [3]. This is of particular relevance to women who experience UI and whose voice is ‘silenced’ by personal vulnerability or societal stigma.

A total of 26 women (22 to 62 years) participated in the focus groups and one-on-one interviews. Qualitative results are shown in Table 1.

All participants were open to the idea of using the femfit and app for home PFM training. The focus groups provided valuable insight into the complexity and nuance of app development, how group members may interact and their relationship with it – along with insight into the diversity of individual’s views. One-to-one interviews enabled participants to engage directly with the femfit and app, followed up with detailed in-depth discussion. Recurring themes throughout the usability study aligned with sections of the MARS document: clear, concise information (Information); progress tracking (Engagement); intuitive aesthetic interface (Aesthetics/Functionality); reliable biofeedback (Engagement/Information). The MARS framework will continue to be central to the assessment of ongoing app iterations.

Human-centered design to develop a mobile app is necessary to effectively communicate health information for self-care management. The utility of this app will be tested in a feasibility study with and without the femfit device.

Stoyanov, S.R., et al., Mobile App Rating Scale: A New Tool for Assessing the Quality of Health Mobile Apps. JMIR mHealth uHealth, 2015. 3(1): p. e27.
Schell, A., et al., Design and Development Of A Novel Intra-Vaginal Pressure Sensor Array, in 46th Annual Meeting of the International Continence Society. 2016: Tokyo, Japan.
Farquhar, C. and R. Das, Are focus groups suitable for 'sensitive' topics?, in Developing focus group research: Politics, theory and practice. 1999, Sage Publications Ltd: Thousand Oaks, CA. p. 47-63.