CORDIS - EU research results

Intimate, home-diagnostic tools for women

Periodic Reporting for period 1 - iTampon (Intimate, home-diagnostic tools for women)

Reporting period: 2015-03-01 to 2015-08-31

At Dr. Dolhay, our mission is to provide female hygiene and health products that serve the health of women and their sexual partners by use in the intimacy of the home.The main objective of our project is to enhance women’s quality of life.The iTampon project involves an innovative method – completely free of electronics – to diagnose female health at home. These two novel diagnostic devices will enable women to detect the sign of any infection, indicating the need to
turn to a gynaecologist. Additional examinations can be carried out by sending samples to our laboratory partner. Early warning of potential diseases, such as cervical cancer or preterm birth, can save millions of lives, as women
could undergo the necessary treatment in time.The need for the products is well demonstrated, as it breaks through the key barrier women have against going to the
gynaecologist: shyness and anxiety. We have developed two prototypes that are essential diagnostic tools at the level of consumer goods – keeping theintimacy of women using them:
1) Intelligent Tampon Observer (iT Observer): it is a “pH meter” (“good flora indicator”) which provides a pH-status map of the whole vagina and cervix.
2) Intelligent Tampon Collector (iT Collector): it is a 2in1 solution, a “pH meter” and “home HPV/cancer test” which enables women to perform a basic gynecological self-examination in the privacy of their home.
Our aim in the Phase 1 project was to assess further the technical and commercial feasibility of the Intelligent Tampon devices and to prepare for the finalization of the development work including a large scale clinical validation. The methodology used through the investigation included technology validation testing and updating design plans, review of relevant medical, legal and technology related literature, analysis of available business and market data and consultation with various stakeholders, experts, end-user and distribution channel representatives.
In the EU-28 countries, 4,2 women out of 100.000 die from cervical cancer each year!
The burden is particularly high in the new member states!
Despite the recommendation in the Eastern-European countries only the 10-30% of the women participate in cervical cancer screening!

On the earth there are approximately half a billion persons who are perilous virus carriers; the majority of them has become infected with the microbes via heterosexual activities and does not even know about the infection; symptoms are not (yet) noticeable; nevertheless they can infect others. An absolutely healthy vagina, its acid mantle and the Döderlein bacillus are the best natural protection against “slow-going” viral and other infections.
Amongst others we live together with the carriers of the following viruses:Hepatitis B, C-; (300 million infected persons; Human Papilloma Virus (250 millions); HIV (45 millions). On the list of cases of death caused by infections they are on the 3rd place (1st tuberculosis, 2nd malaria), on the list of cases of death caused by cancer they are even on place 2 (1st lung cancer).
Wounds and clefts at the cervix, bursts of the cervix uteri, not well-closing perineum, decreased uterus and also pregnancy. Deposit substances: menstruation blood, rests of vaginal uvulas and -tablets. After the elimination of the vaginal infections causing pathogenic germs with medicaments the vaginal acid mantle is destroyed – all that will decimate the power of resistance. Advanced in years the body’s natural power of resistance decreases because of the stepwise decline of oestrogen production.
The self-protection of the vagina can be damaged by many inventions and habits of the last decades (see page 10).
In Central Europe only every fifth procreative woman has a healthy self protection. In case of cancer mass-screening examinations only this minority gets the diagnosis of “Papanicolaou 1” (“P.1”). The majority of 80 percent only gets “Papanicolaou 2” or worse.
The symptom of inflammation is vaginal discharge. Lots of women have to collect their discharge somehow, like by using tampons or panty liners as a daily routine. They do only treat the symptoms this way. Therefrom the sales volume of these products is a multiple of the menstruation-caused necessity. To guard against this situation, professional expert knowledge and the use of products and devices with no side effects is necessary.
The common pathogenic germs remove the defensive epithel of the vagina-wall. Therefrom the Human Papilloma Virus (HPV) can enter deeper and reach the lower, infectable cells. These viruses cause cervical-, vaginal-, vulva- and oral cavity carcinomas. On that way approximately 1.000 women (and men) bitterly die per day from these kinds of cancer! These common causative organisms (e.g. fungi, trichomonas etc.) destroy the vaginal epithel and therefrom the lethal pathogenic germs can much easier reach the deeper parts of human body, the connective tissue. As an aftereffect of the infection also the veins expand, their wall thins down; with mechanical effects (like coitus) (micro) rips can arise and therefrom the expanded pathogenic germs (as Syphilis, AIDS and Hepatitis) can be “pumped” much easier into the partners blood.

Testing for early detection is one of the key factors in fighting severe and often irreversible consequences of inflamed female reproductive system caused by common and Sexually Transmitted Infections. Reduced natural protection of the genital tract – loss of lactobacilli count – often lead to vaginitis which effects 70% of woman aged 15-49 at least once during their life. Bacterial vaginosis, the most common infection during pregnancy occurring in over 20% of cases pose a particular threat for the mother and infant as well. The missed opportunity of timely diagnosis and treatment comes at a high price for individuals and families as long-standing infections can easily progress into serious conditions and fatality including infertility, pregnancy complications, premature birth, related neonatal death (40% of all child death), Pelvic Inflammation Disease (PID) and several types of cancer.

The key value-for money, provided to our customers by Intelligent Tampon products include: wide accessibility through multiply distribution channels, ease-of-use – “normal” tampon shape, easy to operate, intimacy and comfort of testing, additional tests: Pap and HPV and – cancer screening via post, results sent by e-mail and an early warning “system” to seek medical treatment.

We composed a project video, which is also a non-confidential summary of our achievements done within this project. The video can be seen on the home page of our product website;
Our mission
Our solution