As part of the European WOMEN-UP project, in September the Universitat Politècnica de Catalunya and the Hospital Clínic de Barcelona (Spain), along with the Academic Medical Center (the Netherlands) and Kuopio University Hospital (Finland), will carry out the clinical trial of a system designed to improve pelvic floor muscle training, a recommended treatment to prevent or treat urinary incontinence. This technological solution incorporates serious games for mobile phones that are driven by muscle movement and remote medical monitoring through a web platform.
Urinary incontinence is any involuntary urine leakage. It is a condition that can be more or less severe and it affects one in three women of all ages, which is more than 56 million people in Europe and more than 350 million people in the world. It is not a normal part of ageing and has a negative impact on the quality of life of the women who suffer from it. The main risk factors for urinary incontinence are pregnancy and childbirth, overweight and obesity, and high-impact sports. There are several treatments to improve or cure its symptoms, depending on the type of incontinence, and it can also be prevented by taking measures before it appears.
One approach that has proven effective in preventing and treating stress urinary incontinence is pelvic floor muscle training. It consists of a programme of contraction and relaxation exercises for the muscles that form the base of the pelvis. If the treatment is followed and performed correctly with the supervision of a therapist, the rate of cure/improvement may reach 70%. It is very important to know whether the patient is doing the exercises properly, and that can be achieved through biofeedback devices and computer programs that record—via the electrodes in a vaginal probe—and show muscle activity during the exercises. Only a few clinical devices have this technology and none of them monitor abdominal activity to ensure that the exercises are executed correctly.
Mobile games that motivate patients
The technological solution that WOMEN-UP proposes is a system for home treatment that makes use of remote medical monitoring and serious games installed on the patient’s mobile phone to encourage her to carry on with the regular training. The system consists of three elements: wireless devices that capture muscle contractions and send the data to the smartphone, a web platform that collects data and charts the progression of the treatment, and a smartphone application that contains the games. “The therapist obtains information telematically through the platform and monitors and programs customised exercises, while the patient can evaluate the results in real time. Both the patient and the therapist can see the evolution at any time,” explains Miguel Ángel Mañanas, the project’s coordinator and a professor at the UPC’s Department of Automatic Control.
First tests in Barcelona and Kuopio
From late 2016 until February 2017, the Hospital Clínic, in coordination with Kuopio University Hospital (Finland), ran a technical test with 21 patients, 11 from Barcelona and 10 from Kuopio. The test analysed the operation of the first prototype of the system and the participants gave positive feedback and made suggestions that will help to improve it before the clinical trial. “We have seen that patients are more motivated to train than before and they therefore have more chances of success in treatment,” explains Dr Montserrat Espuña, head of the Pelvic Floor Unit at the Hospital Clínic.
Call for the clinical trial with 300 volunteers
The WOMEN-UP project will carry out a final clinical trial of the system with a group of 300 women with light or mild stress urinary incontinence. It will be an international, multicentre trial involving the Hospital Clínic, the Academic Medical Center of Amsterdam and Kuopio University Hospital. The call for volunteers who wish to participate has already begun through the website stopui.com. Specifically, they are looking for 110 volunteers in Barcelona, 110 in Amsterdam and 80 in Finland, a large and varied sample that will allow patients, doctors and nurses to assess health systems that follow different patterns to achieve the same objective: the continued training of the pelvic floor muscles.
About the WOMEN-UP Project
The WOMEN-UP project’s objectives are to improve the quality of life of women with urinary incontinence, to greatly reduce the cost of long-term care and lost productivity due to urinary incontinence—nearly 10 billion dollars, according to the WHO—and to shorten waiting lists. This is the first project of this magnitude that focuses on the treatment of this condition. It is funded by the European Commission within the Horizon2020 programme. It has run since February 2015 and will end in July 2018. The total cost is 3.5 million, of which the EU finances over 3.2 million. The final product will respond to the needs and demands of patients and professionals and will be marketed by a company in the multidisciplinary consortium that is developing the project.
The consortium comprises eight organisations from seven EU countries: Spanish partners the Universitat Politècnica Catalunya (UPC)—the project’s leader—and the Hospital Clínic, Mega Electronics Company Ltd. and Kuopio University Hospital (KUH) in Finland, the Academic Medical Center (AMC) in Amsterdam, the European Urogynaecological Association (EUGA), Babeș-Bolyai University (BBU) in Romania and Swiss company YouRehab Ltd.