PROSPECT

PROSPECT:  Clinical and cost-effectiveness of surgical options for the management of anterior or posterior vaginal wall prolapse: pragmatic evaluation by multi-centre randomised controlled trial - PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trial

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 patients. 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 interventions. 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.

Outcome and Translation

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.

The results of the PROSPECT Trial informed the 2017 Scottish Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women.

HERU researchers involved in this research project: Dwayne Boyers and Mary Kilonzo

External collaborators: C Glazener, A Grant, J Norrie, G MacLennan, A McDonald, G McPherson (HSRU, University of Aberdeen); ARB Smith (St. Mary’s Hospital Manchester); RM Freeman (Plymouth Hospital NHS Trust); C Bain, K Cooper (NHS Grampian); S Hagan (Glasgow Caledonian University) and IBG Montgomery (Aberdeen)propsect logo

Further details are available on the PROSPECT study website.

Publications

Glazener, C., Breeman, S., Elders, A., Hemming, C., Cooper, K., Freeman, F., Smith, A., Hagen, S., Montgomery, I., Kilonzo, M., Boyers, D., McDonald, A., McPherson, G., MacLennan, G. and Norrie, J. (2015) 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: results from the PROSPECT Study. Final report submitted to the National Institute for Health Research (NIHR) Health Technology Assessment Programme.

Glazener, C., Breeman, S., Elders, A., Hemming, C., Cooper, K., Freeman, R., Smith, A., Hagen, S., Montgomery, I., Kilonzo, M., Boyers, D., McDonald, A., McPherson, G., MacLennan, G. and Norrie, J. (2017) 'Clinical effectiveness 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 - results from the PROSPECT Study', Health Technology Assessment, 20(95).

Glazener, C. M. A., Breeman, S., Elders, A., Hemming, C., Cooper, K. G., Freeman, R. M., Smith, A. R. B., Reid, F., Hagen, S., Montgomery, I., Kilonzo, M., Boyers, D., McDonald, A., McPherson, G., MacLennan, G. and Norrie, J. (2016) 'Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT)', Lancet, 389(10067), 381-392.

Glazener, C.M.A., Breeman, S., Elders, A., Hemming, C., Cooper, K.G., Freeman, R.M., Smith, A.R.B., Hagen, S., Montgomery, I., Kilonzo, M.Boyers, D., McDonald, A., McPherson, G., MacLennan, G., Norrie, J., Reid, F. M. and the PROSPECT Study Group (2020) 'Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)', BJOG: An International Journal of Obstetrics and Gynaecology, 127(8), 1002-1013.