
Did you know that approximately 26%1 of women who give vaginal childbirth experience perineal injuries affecting the anal sphincter complex? What is more, up to 4 out of 5 of these cases go undetected2.

Currently, obstetric anal sphincter injuries (OASI) are identified in less than 4% of women who give vaginal childbirth. This demonstrates the unmet need for improved methods and standards for OASI detection. The currently available methods, i.e., primarily the digital rectal examination (palpation), is often the only option available in the labour ward. However, its sensitivity varies, is generally low, and markedly contingent on the obstetrician’s or midwife’s experience. Endoanal ultrasound (EAUS), which is considered the gold standard for detecting OASI, is hardly available at the bedside in labour wards within the standard obstetrics practice.
The ONIRY system, a machine learning-assisted impedance spectroscopy-based medical device, has been developed to fill the critical gap of early, bedside detection of OASI. This system offers a rapid and minimally invasive complement to the digital rectal examination (manual check) that brings detection of OASI to the next level in labour wards.
The early postpartum use of ONIRY can significantly improve the detection rate of OASI. With a sensitivity and specificity of approximately 90%, ONIRY allows for detection of most injuries, including occult ones.
Overall, OASI count as the major cause of faecal/anal incontinence (FI) in women: a vaginal childbirth with any OASI increases the FI risk as much as nearly 4-fold. Research suggests that as many as 44% of women who experience OASIS during childbirth will develop FI later in life3.
Leaving an OASI untreated significantly increases the lifetime risk of developing FI. Incontinence symptoms may appear soon after childbirth or manifest years later. Knowing these potential risks and seeking appropriate care and support is essential.

Fecal/anal incontinence (FI) is a highly intimate and challenging problem that many women face. While more and more health issues are no longer taboo, FI is still considered embarrassing. Symptoms of FI can range from mild to severe. Loss of control over defecation or uncontrolled expulsion of gas are at the severe end. However, even women with less severe FI often hide their symptoms for years and ultimately withdraw from active life. Such symptoms can result in avoidance of social interactions and significantly interfere with daily personal and occupational activities. As a result, this can lead to significant disability because this is not only a health but also a social and economic problem, affecting the quality of life of those affected.
Any OASI during vaginal childbirth can increase the risk of FI by nearly 4 times.
If OASI is left untreated, it significantly raises the lifetime risk of developing FI.
Symptoms of incontinence can appear shortly after childbirth or even manifest years later. It’s crucial to be aware of these potential risks and to seek appropriate care and support.

* Relative Risk = 3.74 (95% Confidence Interval: 2.17 – 6.45, I2=80 %) as meta-analysed by Sideris M, et al. (Eur J Obstet Gynecol Reprod Biol 252 (2020) 303-312) from 2005 women in 19 clinical studies.
Not all women who experience OASI will develop FI. Many could fully recover as long as adequate diagnostics and management are in place. Detecting OASI shortly after delivery is crucial to ensure timely and effective treatment. If primary surgical repair is the chosen option, its therapeutic windows fall within 24-48 hours after delivery.
The early postpartum use of ONIRY can significantly improve the detection rate of OASI. With a sensitivity and specificity of approximately 90%, ONIRY allows for the precise identification of most injuries, including occult ones.
Data support that primary surgical repair offers a higher quality of life and is more cost-effective over 10 years4. The prognosis for women undergoing a timely primary repair of the external anal sphincter is good, with a 60% to 80% chance of being asymptomatic at 12 months. Implementing ONIRY enables far higher detection rates of OASI within the therapeutic window optimal for the primary repair.
By increasing the detection rate of OASI, thus enabling early intervention, ONIRY has the potential to significantly reduce FI rates and improve the overall quality of life of women giving vaginal childbirth.