PEPPY trial
Research type
Research Study
Full title
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
IRAS ID
338183
Contact name
Catriona O'Dolan
Contact email
Sponsor organisation
Glasgow Caledonian University
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
Pelvic organ prolapse is when the organs in a woman’s pelvis descend into her vagina. Prolapse is very common, affecting 40% of women over the age of 50, and becomes more common as women age. It has distressing symptoms and negative effects on women’s daily lives. One common treatment is pelvic floor muscle training (PFMT) where women are taught by a specialist physiotherapist or nurse how to exercise the muscles around their vagina. If this is done regularly, over time it can reduce the symptoms of prolapse. A vaginal pessary is another prolapse treatment. The pessary, which is a plastic or silicone device (often shaped like a ring), is inserted into a woman’s vagina to lift and hold the pelvic organs in place.
The aim of this research is to find out if wearing a vaginal pessary whilst exercising pelvic floor muscles is better at improving symptoms than exercising pelvic floor muscles without a pessary, for women with prolapse.
We will invite women with prolapse who are starting PFMT treatment to take part. Women that agree to take part will have an equal chance of receiving PFMT alone or receiving PFMT and also having a pessary fitted.
We will ask women about their symptoms, quality of life, if they feel an improvement, how acceptable they found treatment, how confident they feel about PFMT, if they had other prolapse treatment and whether their pelvic floor muscles are stronger and their prolapse less severe. We will record this information after 6 & 12 months, and compare the 2 groups of women to see which treatment is best and which offers the NHS best value for money. We will gather information from some women and health professionals on their experiences of the interventions.
We aim to recruit 552 women from 13 NHS sites across the 4 UK nations.REC name
West of Scotland REC 4
REC reference
25/WS/0001
Date of REC Opinion
13 Feb 2025
REC opinion
Further Information Favourable Opinion