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.
UK guidelines recommend that women with prolapse consider PFMT treatment and separately that they can consider pessary treatment. The guidelines suggest that research is needed to find out if adding a pessary to PFMT would be more effective than PFMT alone. If combining these two treatments gives better results, this knowledge can be used to improve the lives of women with prolapse.
We are recruiting women at hospitals across the UK. You can see the locations of the hospitals in the section of the website “where can I take part”. More locations will be added as the trial progresses.
Women over the age of 18 who have been referred for PFMT for prolapse in any of our recruiting NHS centres may be able to take part. However, the following are not eligible for the study:
• women for whom prolapse is not the main presenting problem;
• women currently using a vaginal pessary, unless they are prepared to discontinue use for 1 month before starting the study;
• women who are pregnant or less than 6 months’ postnatal;
• women having active treatment for pelvic cancer;
• women with severe vulval disease
• Women who have cognitive impairment affecting capacity to give informed consent;
Aims of the research
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.
What is involved?
We will invite women with prolapse who are starting PFMT treatment to take part in the study. Women that agree to take part will have an equal chance of receiving PFMT alone or receiving and also having a 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 after 6 & 12 months, and compare the 2 groups of women to see which treatment is best 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.
How long will the study last?
We aim to recruit 552 women to the study. Recruitment will start in ? and women will be followed up for 12 months. The study will run for 42(?) months in total and will end in April 2028.
Funding acknowledgement
This study is funded by the NIHR HTA (project number NIHR160810). More information about NIHR can be found on the NIHR website (
www.nihr.ac.uk
).
Department of Health disclaimer
The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Sponsorship
The study is sponsored by Glasgow Caledonian University and the Trial office is based at Glasgow Caledonian University.
Glasgow Caledonian University (GCU) is the sponsor for this study based in the United Kingdom and the GCU GDPR privacy policy can be accessed at https://www.gcu.ac.uk/privacypolicy/privacynotice#. We will be using information from you and/or your medical records in order to undertake this study. GCU will act as the data controller for this study and are responsible for looking after your information and using it properly. GCU will keep identifiable information about you for 5 years after the study has finished. In addition to GCU, appropriately qualified research staff from University of Stirling and University of Aberdeen may look at your research records in line with their responsibilities to the PEPPY study as data processors.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information at https://www.gcu.ac.uk/privacypolicy/privacynotice#.