Clinical and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a Comprehensive Cohort Study (PROSPECT) (Phase III)

Aim: 

To estimate the effectiveness and cost-effectiveness of different surgical options for the repair of vaginal prolapse

Summary:

The lifetime risk of undergoing surgery for prolapse is nearly 10%. There are several different traditional surgical techniques, none of which have been properly evaluated. The study embedded two large RCTs investigating different surgical techniques for two distinct patient populations of women with vaginal prolapse (primary and secondary) within a comprehensive cohort of all patient s. The economic evaluation investigated the costs and cost-effectiveness of the interventions from the perspective of the NHS and for the women and their families. Information on the cost of the intervention and the use of primary and secondary NHS services by the women (including referral for specialist management) were collected, as were personal costs to the women (such as costs of travelling to appointments and work/social restrictions). Trial participants were asked to complete the EQ-5D at baseline and at 6, 12 and 24 months after randomisation, and -responses were used to compute QALYs. In a sensitivity analysis, QALYs were also estimated from the SF-12 completed at the same time points.

The difference in effectiveness was expressed in terms of the numbers of patients cured and improved. Incremental cost-utility ratios were computed comparing the intervention s. An economic model that considers a longer time horizon was developed to provide additional information for  policy makers. In the model, the findings of the trial were extrapolated to the patient's lifetime.

Outcomes/Impact:

The study concluded that there is no clear superiority of the synthetic mesh, biological graft or mesh kit over standard repair in the first two years after surgery. Unless there is a significant decrease in the reoperation rates for failure in the medium or long term in the mesh or graft arms, compared to standard repair, it is unlikely that any type of mesh or graft is going to be cost-effective, given the excess cost over standard repair and the excess cost of treatment for the adverse effect of mesh exposure or extrusion. Long-term follow-up is now on-going.

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 Hospitals NHS Trust, Kilonzo M - University of Aberdeen, MacLennan G - University of Aberdeen, McDonald A, University of Aberdeen, McPherson G - University of Aberdeen, Montgomery I - consumer, Norrie J - University of Aberdeen, Smith A - Central Manchester University Hospitals NHS Foundation Trust.

Funder: NIHR