Materna Medical has touted results from its pelvic floor dilator designed to reduce muscular injury during first-time vaginal deliveries.

The results, published in the International Urogynecology Journal, demonstrated the device significantly reduced the incidence of injury to the levator ani muscle.

The US company says it now is enrolling patients for a pivotal trial to support marketing submission to the US Food and Drug Administration (FDA).

The levator ani muscle is a funnel-shaped group of muscles that form the majority of the pelvic floor and is particularly susceptible to being torn from its attachment to the bone, a type of injury known as avulsion.

The study’s lead investigator Helai Hesham said the injury occurs around 15% of the time and can lead to significant symptoms of sexual, urinary, or faecal dysfunction. There is currently no proven way to prevent this injury, according to Materna.

Materna’s intravaginal device, named Materna Prep, gently stretches the vagina and surrounding muscles to help prepare the area for childbirth. It is 12.6cm long and 3.4cm in diameter and inserted into the vagina when the patient is in labour. The device has four arms that expand outward in slow increments using an inbuilt setting. This pre-stretches the vagina and surrounding pelvic muscles.

Materna’s multi-centre, randomised, controlled trial enrolled 214 women who were planning vaginal delivery and had never given birth before.

The primary effectiveness endpoint of the trial, named EASE, was the presence of full levator ani muscle avulsion at three months. The primary safety endpoint was adverse events throughout the same period.

Materna’s device proved successful on both endpoints. No full levator ani muscle avulsions occurred in the 46 patient-strong group who received the dilator. In the control group, seven out of 64 women suffered the injury, resulting in a rate of 10.9%.

There was one single maternal serious adverse event of laceration linked to the device, whilst no serious counterparts were seen in neonates due to the device.

Dr Kara Rood, also an investigator of the EASE study, said: “We are hoping that by slowly pre-stretching the pelvic floor muscles before the start of pushing the baby out, we can significantly reduce the injuries that can lead to pelvic organ prolapse. The Materna Prep Device is the first device aiming to prevent pelvic muscle injury, so we’re excited to be publishing these results.”

Materna also has an FDA-cleared over-the-counter vaginal dilator to support patients with vaginismus and related painful sex. The device, named Milli, is being studied in a post-market prospective virtual study named POMPOM.