Background
Endometriosis is a chronic inflammatory disease defined as the presence of endometrium-like tissue outside the uterus(1). Establishment and growth of such endometriotic tissue is estrogen-dependent(2), thus it is mostly found in women of reproductive age. It is estimated that currently at least 190 million women and adolescent girls worldwide are affected by the disease during reproductive age although some women may suffer beyond menopause(3).
The Problem
Despite years of chronic pelvic pain, discomfort, and other incapacitating symptoms, some women receive their first diagnosis of endometriosis when attempting, and failing, to conceive. This is associated with several pain-points in the system: (i) The gold standard for diagnosis of endometriosis is laparoscopy, which requires an operative procedure under general anaesthesia to visualise the lesions which is expensive and not without risks. However, the presence of lesions does not preclude other pathologies for the patient’s symptoms such as irritable bowel syndrome; (ii) This is exacerbated by the fact that women who visit their GP with pain, which can be described as ‘intense’ and ‘overwhelming’, can be overlooked due to trivialization/normalisation of symptoms or misdiagnosis. The correct diagnosis is made as late as 7 – 12 years from the onset of pain symptoms to a surgical diagnosis (4). More worryingly, the longest delays are experienced by adolescents; (iii) Compounding matters is the fact that the disease is highly individual. The extent of endometriotic lesions does not correlate with disease stage or symptom severity. Therefore, there are likely to be many subsets of patients, all presenting with various symptoms at various disease stages who require different treatment approaches. Now is the time to change this paradigm by increasing access to timely diagnosis and early treatment. That is precisely what is proposed with our novel digital biomarker.
The Technology
The technology is an accurate non-invasive test that enables simpler, earlier, and more cost-effective diagnosis of patients with endometriosis. The test should enable physicians to make informed medical decisions to prevent disease progression and potentially safeguard fertility. Core to technology development is the investigation and validation of a novel digital biomarker. The electrical activity of the uterus recorded by uterine electromyogram (EMG), also known as electro-hysterogram (EHG), is known to be representative of uterine contractility/motility. While numerous studies have demonstrated the feasibility of using EHG to predict preterm birth, as well as external monitoring of uterine contractions in pregnant women, limited studies have been performed to understand the uterine electrical activity in non-pregnant women. This is the focus of the EndoSolve project where we seek to understand this bio-signal and develop a novel digital biomarker with clinically acceptable sensitivity and specificity to perform as a non-invasive, adjunct diagnostic test which can be used at home for women with suspected endometriosis.
1 ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod 2005;20: 2698-2704.
2 Kitawaki J, Kado N, Ishihara H, Koshiba H, Kitaoka Y, Honjo H. Endometriosis: the pathophysiology as an estrogendependent disease. J Steroid Biochem Mol Biol 2002;83: 149-155.
3 Zondervan KT, Becker CM, Missmer SA. Endometriosis. N Engl J Med 2020;382: 1244-1256.
4 As-Sanie, Sawsan, et al. Assessing research gaps and unmet needs in endometriosis. American Journal of Obstetrics and Gynecology, 2019, 221.2: 86-94
