Randomised controlled trial of the clinical and cost effectiveness of supervised pelvic floor muscle training plus vaginal pessary compared to supervised pelvic floor muscle training alone for management of pelvic organ prolapse

Aims of the research
The aim of this research is to find out if, by wearing a vaginal pessary whilst exercising their pelvic floor muscles, women with prolapse can improve their symptoms more than by exercising their pelvic floor muscles without a pessary.
Design and method used
We will invite women with prolapse who are starting PFMT treatment to take part in the study. Women agreeing to take part will be placed at random (like tossing a coin to decide) into one of two groups. One group will receive PFMT, and the other will receive PFMT and also have a vaginal pessary fitted. We will collect information on women’s prolapse symptoms, their quality of life, whether they feel an improvement, how acceptable they found treatment, whether they had to have other prolapse treatment and whether their pelvic floor muscles are stronger. We will record this information at two timepoints (after 6 and 12 months) to see which treatment is best for women and which offers the NHS the best value for money. We will ask women in each group about their experiences. We will also ask NHS staff about their experiences of the study and the treatments. This will help us explain why the combined treatment did or did not work better for women.