Community Research and Development Information Service - CORDIS

H2020

WOMEN-UP Report Summary

Project ID: 643535
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - WOMEN-UP (Cost effective self-management of urinary incontinence addressed to women across Europe)

Reporting period: 2015-02-01 to 2016-04-30

Summary of the context and overall objectives of the project

The WOMEN-UP Project is developing a cost-effective solution for female urinary incontinence. This solution is based on lifestyle interventions and pelvic floor muscle training (PFMT), both guided via a smartphone app in connection with a set of biofeedback devices and which also provides remote supervision from a therapist.

Urinary incontinence (UI), considered as a disease according to the World Health Organization, is not a life-threatening condition, but causes a very negative impact on daily living and quality of life. 56 million European citizens are affected by UI. A European survey found a prevalence of UI in 35% of women of between 18 and 99 years old. Most of them are untreated due to lack of awareness of clinical treatments and/or sociocultural barriers. Besides, it increases costs on health and social care services, especially taking into account long-term, as UI is one of the major predictors of admission to long-term institutional care.

Strengthening te pelvic floor muscles by training is proven to be effective if it is done correctly. But following a training plan and performing the contractions properly is demanding and difficult, so many patients eventually give up or do it wrong. WOMEN-UP is conceived to encourage and help the patients along the treatment by games and constant professional supervision, allowing women to self-manage their issue at home and saving great costs and time to the healthcare system and themselves.

WOMEN-UP is a European project formed by a consortium of eight organizations from six countries. Technical partners, research institutions and the end users work together while also staying in contact with medical associations to ensure that the product will meet society´s needs.

The overall objectives are to improve the quality of life of women who suffer UI by developing a global and holistic treatment. This is to provide an innovative approach for the supervision of PFMT, to increase patient engagement via biofeedback games and social networks, to assess the cost-efficiency of the proposed solution to significantly reduce health system costs and to make eHealth tools more effective, user-friendly and widely accepted by involving professionals and patients in strategy, design and implementation.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The WOMEN-UP solution is divided into the portable device for pelvic floor muscle training (PFMT), the serious games for smartphones, and the platform for the patient-to-therapist interface for home training in pelvic floor education, including lifestyle advice for urinary incontinence. A trial protocol is complete and the necessary documentation for ethical application has been assembled.

Initially, a series of surveys (using certified questionnaires) were carried out to determine the system requirements. Both patients and professionals were included in the surveys to identify preferences, recommendations and risks, which have been translated into the specifications of the portable device, the platform, and the mobile games.

A preliminary design of the vaginal and abdominal biofeedback device has been developed, based on improvements of existing implementations. New probe shapes and electronics are currently under evaluation and will define the design of the final device.

The web platform features a secure web that contains the tools for interaction between patients and therapists: allowing patients to browse through their results and communicate with their therapist, and facilitating therapists the tasks of exercise assessment and adherence to the programmed sessions. At the same time, implements automatic methods to examine the sessions performed by the patients, informing therapist of any deviation or problem and advising patients to encourage them to follow their treatment plan.

The mobile app receives the data recorded by the portable device (wirelessly) and sends it to the web platform via Wi-Fi or mobile data connection. Exercises are carried out though interactive games that provide useful biofeedback for correct treatment of the pelvic floor muscles. The games have been designed taking into account the value of serious gaming in improving treatment outcomes, as evidenced by the study of current gaming approaches, and according to the preferences shown by the surveys.

Finally, the project has put up several tools for dissemination. These include a website (www.women-up.eu), several social media profiles (www.facebook.com/WOMEN.UP.eu, twitter.com/womenup_eu, www.linkedin.com/company/women-up-project, and www.youtube.com/c/ women-upEU) and a video that will be used as the presentation of the project (mass media) and for recruitment of patients for the clinical trials.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The work carried out is innovative and the first prototype developed, its testing and the clinical trials are scheduled for the next reporting period. The expected improvement on the vaginal probe and the games will lead to innovative aspects on their development, beyond the state of the art of current alternatives for self-training of pelvic floor muscles, which mainly rely on pressure sensors and simple feedback such as vibration or audio messages. This does not allow to assess that proper training of the pelvic floor is being carried out (without involving other muscles that may even worsen the condition of the pelvic floor) nor it does engage the patients to follow a training plan encouraging self-treatment and self-improvement.

This kind of approach for urinary incontinence management and treatment supposes an innovative breakthrough, helping patients manage their training, receiving inputs on lifestyle interventions, and finding motivation to follow the exercise plan through various forms of interaction with other patients and therapists. Moreover, the clinical trials will provide the necessary evidence to assess the increased adherence to the treatment using serious gaming, biofeedback, lifestyle support, and self-management.

Therefore, the potential impact of the WOMEN-UP project relies on the improvement in quality of life thanks to an engaging home treatment, with significant reduction of costs with respect to treatment performed in hospitals and health care centres. The key features of the developed training system will not only empower patients to monitor and self-manage their therapy, but also motivate them during the exercising sessions. This will also result in an improvement of the confidence on eHealth systems among healthcare professionals and patients.

Regarding the economic impact, large cost is often incurred by the patient when paying for routine care products, treatments, and long-term care. These patient costs vary by country, but such products are rarely covered and can be very expensive. The most effective strategy for conservative treatment, supervised pelvic floor muscle treatment, is only offered by a few clinical institutions due to its high cost. In some European countries patients seek a surgical treatment, incurring direct medical costs of surgery as well as indirect costs for absence from work during recovery , but probably the foremost economic burden of UI is associated with the use of incontinence pads, used by the majority of women who do not seek medical treatment.

The eHealth solution developed in the WOMEN-UP project will provide a personalised solution for self-treatment (with medical supervision) and will lead to exploitable results, delivering innovation to the market.

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