Summary

Vault or Uterine prolapse surgery evaluation: Two parallel randomised controlled trials of surgical options for upper compartment (vault or uterine) pelvic organ prolapse (VUE)

Around one in ten women will need prolapse surgery at some point in their lives. Prolapse occurs when the pelvic organs (such as the bladder, the bowel or the womb) come down into, or out of, the vagina. This is caused either by weakness of the tissues which usually support these organs or by weak pelvic floor muscles. There are many different operations for prolapse and there is a high failure rate after surgery. There is not enough evidence to identify which operation is best for these two types of prolapse.

VUE is a multicentre randomised controlled trial, funded by the NIHR HTA programme.

The VUE trial aims to compare surgeries for uterine or vault prolapse to one of two trials:

1. Uterine trial: vaginal hysterectomy compared with an operation to suspend the uterus without removing it,

2. Vault trial: suspending the vault from below (the vaginal route) compared with suspending it via the abdomen (tummy).

VUE will randomise 910 women (630 in the Uterine Trial and 280 in the Vault trial) over 3 years.

The primary clinical outcome is women’s prolapse symptoms measured using the Pelvic Organ Prolapse Symptom Scale (POP-SS), at one year after surgery.

The VUE trial is led by Dr Christine Hemming based at NHS Grampian.

VUE closed to recruitment in 30 November 2016.

For more information please see the VUE Study Website

Contact person

Lynda Constable; l.constable@abdn.ac.uk

Status

Data Collection - Follow-up