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Cost effective self-management of urinary incontinence addressed to women across Europe

Periodic Reporting for period 4 - WOMEN-UP (Cost effective self-management of urinary incontinence addressed to women across Europe)

Okres sprawozdawczy: 2018-08-01 do 2019-05-31

The WOMEN-UP Project has developed a cost-effective solution for female urinary incontinence (UI). 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.

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, 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.
The WOMEN-UP solution is divided into the portable device for 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.

The mobile app receives the data recorded by the portable device (wirelessly via BT) 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.

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.

We successfully performed a Randomized Controlled Trial (RCT) in three European countries. A total of 263 women provided written informed consent and were randomly assigned to the WOMEN-UP group or the usual care PFMT group for 3 months of treatment. Data at 3 months demonstrated that the change in primary outcome related to the UI symptoms was comparable in the WOMEN-UP group and the control group, demonstrating that treatment with WOMEN-UP was similar to usual care PFMT.

We have also demonstrated that the satisfaction specifically with the women-up system was good or very good with most of patients. In conclusion, treatment with the WOMEN-UP system resulted in improvement of symptoms and improvement in quality of life.

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).
The work carried out is innovative and the new design for the vaginal probe and the games 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.

The WOMEN-UP system with CE mark as medical device enables remote monitoring of PFMT treatment, which facilitated insight in training results and enabled therapist to objectively monitor adherence to the treatment. This is especially important, since adherence has been identied as an important predictor of overall PFMT efficacy and treatment supervision is a key point to achieve improvement in PFMT: women receiving regular supervision are more likely to report improvement than women doing PFMT with little or no supervision. In addition, a decrease up to 35% has been estimated in the budget impact thanks to the new WOMEN-UP system.

Consequentlym, results demonstrated Improvement of UI symptoms similar to the usual care, potential economic savings as estimated in the cost-analysis, considerable time savings for patients, following from less travels associated with fewer visits to their (uro) therapists. These time savings represent opportunity costs, as patients may use this time for many other valuable activities.

Summarizing, Women-Up treatment model has clinical benefit for patients, this increases flexibility and autonomy, in combination with more entertaining approach to PFMT exercises as well as substantial time savings makes the Women-Up self-management solution an attractive alternative to usual care PFMT as currently offered for UI.

The eHealth solution developed in the WOMEN-UP project provides a personalised solution for self-treatment (with medical supervision) and leads to exploitable results, delivering innovation to the market.
Flyer used for dissemination, page 4 of 4
Rollup used for dissemination
Flyer used for dissemination, page 3 of 4
First Prototype (including vaginal probe, belt, and bluetooth transmitter)
Flyer used for dissemination, page 1 of 4
WOMEN-UP Logo
Vaginal wireless device
WOMEN-UP system
Flyer used for dissemination, page 2 of 4