VUE

Vault or Uterine prolapse surgery Evaluation – two parallel randomised controlled trials of surgical options for upper compartment (uterine or vault) pelvic organ prolapse

Aim(s):

The primary objective is to determine the optimal surgical management for women with upper compartment (uterine or vault) pelvic organ prolapse, in terms of clinical effectiveness, cost-effectiveness and adverse events. The two parallel trials will compare: (a) in women having uterine prolapse surgery, the effects of removal of the uterus versus uterine preservation; {b) in women having vault prolapse surgery, the effects of a vaginal vault suspension versus an abdominal vault suspension.

Summary:

Gynaecologists have recognised for some time that both anatomical failure and recurrence of prolapse symptoms after surgery are common: one in three women who have a prolapse operation will go on to have another, though not necessarily in the same compartment. More recently, it has also been recognised that surgery can be followed by a greater impairment of quality of life than from the original prolapse itself (for example the development of new-onset urinary incontinence after surgery, or prolapse at a different site). Whilst anterior and posterior prolapse surgery is most common (90% of operations), around 43% of women also have a uterine (34%) or vault (9%) procedure at the same time. Indeed, this demonstrates that women who have a hysterectomy have around a 27% chance of needing a subsequent vault prolapse repair. These data are derived from the first 700 women recruited in PROSPECT, a large HTA-funded UK RCT of anterior or posterior prolapse surgery with or without the use of mesh {HTA No. 07/60/18). In VUE, the opportunity has arisen to then switch from randomising between lower compartment surgery to trials involving different surgical options for upper compartment prolapse (uterine and vault).

Principal Investigator: University of Aberdeen

NMAHP Research Unit Collaborators: Professor Suzanne Hagen, Andrew Elders

External Collaborators: Bain, C - NHS Grampian, Breeman, S - University of Aberdeen, Cooper, K - NHS Grampian, Freeman, R - Plymouth Hospital NHS Trust, Kilonzon, M - University of Aberdeen, McDonald, A - University of Aberdeen, McPherson, G - University of Aberdeen, Norrie, J - University of Aberdeen, Smith, A - Central Manchester University Hospitals NHS Foundation Trust.

Funder: NIHR