Could an artificial sphincter solve condition affecting hundreds of millions of women globally?

The health tech firm UroMems believes it has moved a step closer to a new era of treatment for women with stress urinary incontinence (SUI).

The company has reported on positive progress in its clinical feasibility study for its UroActive system – a smart, automated artificial urinary sphincter – as a treatment for SUI.

UroMems says the entire treatment cohort of women involved in the trial has successfully reached “the six-month primary endpoints”.

“This milestone indicates a new era for millions of women suffering from SUI, and signals an exciting transition for surgeons treating SUI not only in France, where the study was conducted, but also across the US and Europe,” the company said.

One-year results for the first patient later this week at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Winter Meeting in California.

Hamid Lamraoui, UroMems chief executive officer and co-founder, said: “With women suffering from higher rates of SUI and currently no effective solutions available to them, we are ecstatic to be the first to demonstrate the feasibility of our breakthrough technology now in a total of 12 women and men.

“All of the female patients participating in our study have returned to living life fully after years of struggling with SUI. We sincerely thank them for participating in our study along with their physicians and our team for bringing this one step closer to providing a new and effective option to the millions of people suffering from SUI in the US and Europe.”

The female feasibility assessment of the UroActive System was completed through a prospective multicenter clinical study. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI, and the only one to reach this critical milestone.

The six women in the multicentre trial have been implanted with the artificial sphincter for between seven months and almost two years.

The devices have operated as expected with no need for revision nor explant, trial findings show.

Also, “phenomenal follow-up” was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.

UroActive is the first smart active implant that treats SUI, powered by a ‘myo electro-mechanical system’ (MEMS). This is placed around the urethral duct and is controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.

UroMems recently secured US$47m in funding to support the development of its product.

SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans. It significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. Globally, half of all women over 50 are said to experience some form of incontinence.