OP14.07: Does the Epi‐No device prevent levator trauma? A randomised controlled trial

Abstract

Objectives: In 10–30% of women, vaginal birth results in levator ani tears which are associated with female pelvic organ prolapse. Prevention of levator trauma may reduce the future prevalence of this condition. The Epi-No is an inflatable balloon device designed to stretch the vagina and perineum in late pregnancy. This study was designed to evaluate the effect of Epi-No use on pelvic floor integrity. Methods: This was a prospective randomised controlled trial. 200 nulliparous women (singleton pregnancy at 33–37 weeks’ gestation) were recruited. All were invited for a 2nd assessment >= 3 months postpartum. All participants had an interview and 4D translabial ultrasound at both appointments. Participants were randomised into the control or Epi-No group. Women in the intervention group were instructed in the use of the device from 37 weeks onwards. The primary outcome parameter was levator avulsion. Modified intention to treat (ITT) and treatment received analysis were performed. Results: 96 women were randomised to the control group, 104 to the Epi-No group. There were no significant differences in obstetric variables. 145 women (73%) had a second assessment 5.6 (2.3–22.1) months postpartum. There were 13 avulsions (3 bilateral, 10 unilateral), with the risk halved in the Epi-No group (6% vs. 13%, P = 0.19). Similar findings were obtained after adjustment for known confounders such as antepartum BMI, intrapartum use of epidural, length of 2nd stage and forceps delivery. The treatment received analysis yielded similar results. Conclusions: In this randomised controlled pilot study we found a weak trend towards a lower incidence of levator avulsion in the Epi-No group. While the intention to treat analysis showed a halving of risk, the unexpectedly low prevalence of avulsion in our population has resulted in insufficient power. Based on these findings an ITT study would need a sample size of 660 women to show a reduction in the incidence of levator avulsion by 50%.