CompletedInterventional

A pilot and feasibility study comparing vaginal continence devices and pelvic floor muscle training (PFMT) versus PFMT only for female stress urinary incontinence

This study, called FEEL-GOOD, is looking for better ways to help women who experience accidental urine leaks, especially when they cough, sneeze, or laugh. This condition, called stress urinary incontinence, affects many women and can be upsetting. The study compares two approaches: one group will only do pelvic floor muscle exercises, while another group will do these exercises and also use a small device worn inside the vagina, which helps support the bladder. The main goal is to see if combining the exercises with the device works better than the exercises alone. Researchers hope to learn if this new combination can improve quality of life and potentially reduce the need for surgery. This initial study will help plan how to do a larger study in the future.

At a glance

Status

Completed

Sponsor

University of Aberdeen

Enrolment target

Start

06 May 2025

Estimated completion

30 Jan 2026

Female stress urinary incontinence

What is this study about?

Many women experience accidental urine leaks when they cough, sneeze, laugh, or exercise. This is called stress urinary incontinence, and it's a common issue that can make daily life difficult and affect how women feel about themselves. The first thing doctors usually suggest is doing special exercises to strengthen the pelvic floor muscles. However, for some women, these exercises aren't enough, and they might need surgery.

There are also small devices, similar to a tampon or diaphragm, that can be worn inside the vagina. These devices, called vaginal continence devices (VCDs), help to support the bladder and reduce leaks. Current guidelines suggest using these devices if pelvic floor exercises alone don't work. This study wants to find out if using these devices *together* with pelvic floor exercises is more helpful than just doing the exercises on their own. The researchers believe this combination might improve women's quality of life and potentially mean fewer women need surgery.

Right now, we don't have a lot of clear information about how well these vaginal devices work, what the possible downsides are, or if they are good value for money. This study is an important first step. It's a 'pilot and feasibility study,' which means its main aim is to gather enough information to help plan a larger, more comprehensive study in the future. The results of this study will help doctors and the NHS understand how best to treat women with stress urinary incontinence.

Key takeaways

This study compares pelvic floor exercises alone versus exercises with a vaginal device for bladder leaks.
It aims to improve ways of treating accidental urine leaks in women.
Participation lasts 6 months and involves regular check-ins about symptoms.
There are no expected extra risks beyond standard NHS care.
Your involvement helps improve future treatments for many women.
You will be randomly assigned to one of two treatment groups.

Who may be eligible?

The FEEL-GOOD study is looking for women who are 18 years old or older and have stress urinary incontinence, which means they leak urine when they cough, sneeze, or laugh. The doctors involved need to agree that using a vaginal device would be suitable for you, and you must be willing to manage the device yourself.

There are some reasons why you might not be able to join. For example, if you have a significant prolapse (where your pelvic organs drop), certain nerve problems affecting your bladder, or if your main problem is a sudden, strong urge to go to the toilet rather than leaks from coughing or sneezing. You also can't take part if you have an active infection in your pelvis or vagina, vaginal sores, or if you're allergic to silicone or rubber, as these materials are in the devices.

Additionally, you can't join if you are currently pregnant or have given birth in the last six months, or if you've recently completed a full course of supervised pelvic floor muscle training within the last two years. If you've had pelvic surgery in the last six months, are being treated for pelvic cancer, or have trouble with your hands that would make it hard to insert or remove the device, you wouldn't be able to participate. You also need to be able to understand the study information and questionnaires in English.

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 18 years old or older?
Do you mainly experience urine leaks when you cough, sneeze, or laugh?
Are you willing and able to insert and remove a small device in your vagina if you are in that group?
Have you *not* had major pelvic surgery in the last 6 months?
Are you *not* currently pregnant or within 6 months of having given birth?

Answer every question to see your result.

What does participation involve?

If you agree to take part, you'll first be asked to read some detailed information about the study and sign a consent form. You will then be randomly assigned to one of two groups, like flipping a coin, so you have an equal chance of being in either group. One group will focus solely on pelvic floor muscle exercises. The other group will do these exercises *and* also use a vaginal continence device.

Before you start, and then again after 3 and 6 months, you'll be asked about your symptoms and how your quality of life is. This will involve answering questions and providing information. The total study period for you would be 6 months. All treatments and assessments will be carried out by trained healthcare professionals who already work in the NHS. The study is designed so that nothing you do as part of taking part carries extra risks compared to standard NHS care for your condition.

Potential risks and benefits

You might not personally feel better just by being in this study. However, by taking part, you would be helping researchers learn more and improve how women with stress urinary incontinence are treated in the future, potentially helping many others. The results will also help the NHS plan better services. We don't expect any extra risks from joining this study, as all the treatments are already used in the NHS. Any treatment, however, has potential side effects, such as muscle discomfort, back or tummy pain, vaginal irritation or discharge, or infections. Your healthcare team will discuss all known potential risks as part of your usual care, and steps are always taken to keep these risks as low as possible. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (6)

NHS Grampian
Approximate
Aberdeen, Scotland
Leeds Teaching Hospitals NHS Trust
City only
Leeds, England
Countess of Chester Hospital
Approximate
Chester, England
Huddersfield Royal Infirmary
City only
Huddersfield, England
St Mary's Hospital
Approximate
Manchester, England
Queen Elizabeth University Hospital
Unverified
Glasgow, Scotland

Common questions

What is stress urinary incontinence?

It means you leak urine accidentally, especially when you cough, sneeze, laugh, or exercise, due to weakness in the muscles that support your bladder.

What are pelvic floor muscle exercises?

These are special exercises that help strengthen the muscles that support your bladder, bowel, and uterus, which can improve bladder control.

What is a vaginal continence device (VCD)?

It's a small device, like a soft ring or cube, that you wear inside your vagina. It helps to support your bladder and reduce urine leaks.

How long will I be in the study?

Your involvement in the study will last for 6 months.

Where is the study happening?

The study is being run from the University of Aberdeen in the UK, and women will be recruited from 4-6 hospitals across the UK.

How to find out more

Uzunma Onyeakazi

uzunma.onyeakazi1@abdn.ac.uk +44 1224 438181 Official trial record

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