RecruitingInterventional

Pelvic floor muscle exercises plus pessary for treatment of prolapse versus pelvic floor muscle exercises alone

This study is for women with pelvic organ prolapse, a common condition where pelvic organs drop down into the vagina. It compares two ways to help with this. One group of women will do pelvic floor exercises, taught by a specialist. The other group will do the same exercises, but also use a soft, ring-shaped device called a vaginal pessary to help hold things in place. The aim is to find out if using both treatments together is more effective at making symptoms better than just the exercises alone. This research hopes to improve treatments for women with prolapse and potentially save NHS costs in the long run.

At a glance

Status

Recruiting

Sponsor

Glasgow Caledonian University

Enrolment target

552

Start

01 May 2025

Estimated completion

31 Oct 2026

Pelvic organ prolapse

What is this study about?

Pelvic organ prolapse is a very common condition where the organs inside a woman's pelvis, like the womb or bladder, can drop down into her vagina. This often causes uncomfortable symptoms and can affect daily life. It becomes more common as women get older, affecting many over the age of 50.

Two common ways to help with prolapse are pelvic floor muscle exercises and using a vaginal pessary. Pelvic floor exercises involve learning how to strengthen the muscles around your vagina with the help of a specialist physiotherapist or nurse. A vaginal pessary is a soft, plastic or silicone device, often shaped like a ring, that is placed inside the vagina to gently support the organs and keep them in their proper place.

Currently, women in the UK might be offered either of these treatments separately. Some experts believe that combining them might work better, as the pessary could help support the organs while the exercises strengthen the muscles. This study aims to investigate if using a pessary alongside pelvic floor exercises provides better relief from symptoms than just doing the exercises alone. This will help understand the best ways to treat prolapse, potentially improving the lives of many women and making healthcare more efficient.

Key takeaways

The study compares pelvic floor exercises alone versus exercises with a vaginal pessary for prolapse.
It aims to find the best way to reduce prolapse symptoms and improve women's lives.
Participation involves 16 weeks of exercises and follow-up checks at 6 and 12 months.
You will be randomly assigned to either the exercise-only group or the exercise-plus-pessary group.
The study is helping to shape future treatments for pelvic organ prolapse in the UK.

Who may be eligible?

This study is looking for women aged 18 and over who have been told by their doctor or nurse that they have pelvic organ prolapse and have been referred for pelvic floor muscle training. You can still take part even if you've had treatment for prolapse before, like exercises, a pessary, or surgery.

However, there are some reasons why you might not be able to join. For example, if your main problem isn't actually prolapse, or if you're already using a vaginal pessary (unless you stop using it for a month before the study starts). You also can't take part if you are pregnant, have given birth less than six months ago, or are receiving treatment for pelvic cancer.

We also can't include women who have severe skin problems in the vaginal area or those who might have difficulty understanding what the study involves and giving their permission to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Have you been referred for pelvic floor muscle training because of prolapse?
Are you NOT pregnant or have given birth more than 6 months ago?
Are you NOT being treated for pelvic cancer?
Do you NOT have severe skin conditions in the vaginal area?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be put into one of two groups by chance, like flipping a coin. You won't get to choose which group you're in. Both groups will follow a 16-week program of pelvic floor muscle training, led by a specialist. This will involve 5 appointments, with at least 3 of these appointments being in person. The exercises will be specially designed for you, and you'll be asked to do them daily at home.

If you're in Group 1, alongside your exercises, you'll also be given a vaginal pessary to wear. You can leave it in or take it out sometimes, depending on what's comfortable for you. If you're in Group 2, you'll only do the pelvic floor exercises. During the study, you'll be asked to complete a daily diary for one week between each appointment, recording your exercises and if you used a pessary. We will then check in with you after 6 months and 12 months to see how your symptoms are, how your quality of life is, and if you feel better. We'll also ask about your experiences and if you needed any other treatments for your prolapse.

Potential risks and benefits

Taking part in this study could help you manage your pelvic organ prolapse symptoms better and improve your quality of life, whether that's through pelvic floor exercises alone or with the added support of a pessary. The information we gather will also be very valuable in helping to improve treatments for other women with prolapse in the future. As with any medical treatment, there's a small chance of minor discomfort or irritation from the pessary, or from the exercises themselves, but these are generally well-managed. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

South Tees Hospitals NHS Foundation Trust
City only
Middlesbrough, England
North West Glh Led by Manchester University NHS Foundation Trust
City only
Manchester, England
NHS Tayside
City only
Dundee, Scotland
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland
Cambridge University Hospitals NHS Foundation Trust
Unverified
Cambridge, England
NHS Grampian
Unverified
Aberdeen, Scotland
King's College Hospital NHS Foundation Trust
Unverified
London, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
Unverified
Norwich, England
Sheffield Teaching Hospitals NHS Foundation Trust
Unverified
Sheffield, England

Common questions

What is pelvic organ prolapse?

It's when organs in a woman's pelvis, like the bladder or womb, drop down into the vagina, often causing uncomfortable symptoms.

What are pelvic floor muscle exercises?

These are special exercises to strengthen the muscles around the vagina, which can help support the pelvic organs.

What is a vaginal pessary?

It's a soft, device, often ring-shaped, inserted into the vagina to gently hold and support the pelvic organs in place.

How long will the study last for me?

You'll be doing a 16-week exercise program and then we will follow up with you at 6 months and 12 months after the program starts.

Will I have to pay to be in the study?

No, the study treatments and appointments are provided as part of the research and are funded by the National Institute for Health and Care Research (NIHR).

How to find out more

Suzanne Hagen

s.hagen@gcu.ac.uk +44 (0)7920751281 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.