Not yet recruitingOBSERVATIONAL

UK PureWick™ At-Home Pilot Study

The UK PureWick™ At-Home Study is exploring a new way to manage urinary incontinence in women. This condition causes accidental urine leaks. Instead of a traditional catheter, which goes inside the body, the PureWick™ System sits outside to collect urine. Researchers want to understand if this external device works well for women using it at home. They're also keen to find out if women prefer PureWick™ over their current catheters, how it affects their sleep patterns, and their general quality of life. The main goal is to identify if PureWick™ is an effective and comfortable alternative for women dealing with urine leakage, especially those who've had problems with internal catheters in the past.

At a glance

Status

Not yet recruiting

Sponsor

Becton, Dickinson and Company

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Nov 2026

Urinary Incontinence

What is this study about?

This study is about a new device called the PureWick™ System, which helps women who have trouble controlling their bladder and leak urine. This condition is also known as urinary incontinence. Normally, some women might use a special tube called a catheter that goes inside the body to help drain urine.

The PureWick™ System is different because it collects urine from outside the body. This study wants to see how well this external device works for women using it at home. They're particularly interested in whether it's a good choice for women who have had problems with their usual, internal catheters.

Researchers will be looking at several things: how good the PureWick™ System is at managing urine, if women prefer using it, whether it helps with sleep, and if it improves their general comfort and well-being. The aim is to find out if PureWick™ can be a better, more comfortable option for managing urine leakage at home.

Key takeaways

This study is for women with urinary incontinence who use internal catheters.
It tests an external device (PureWick™ System) as an alternative to internal catheters.
The study focuses on women who have had problems with their current catheters.
Researchers want to know if the PureWick™ System improves comfort, sleep, and overall well-being.
Participation includes training and using the device at home for four weeks.

Who may be eligible?

To join this study, you need to be a woman who is 18 years or older. You should currently be using an internal catheter (a tube inside your body) because of urine leakage, and you must have been using it for at least four weeks before the study starts. Importantly, you should have experienced problems with your catheter in the last month, needing at least five visits or calls to a doctor or nurse for help with it.

There are also some reasons why you might not be able to join. For example, if you often have problems with bowel incontinence and don't use a special system for it, or if you have very heavy periods that you can't manage with a tampon or cup. If you have active infections in your genital area, wounds, or skin irritation, you also wouldn't be able to take part.

Other reasons for not being suitable include if you are pregnant, have a bladder infection when the study starts, or if you have any condition that would make it difficult to answer questions about your quality of life. The study also can't include you if you produce a lot of urine and wouldn't be able to empty the collection bag yourself or with the help of a carer.

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 a woman aged 18 or over?
Do you currently use an internal catheter for urine leakage?
Have you had at least five problems with your catheter in the last month that needed medical help?
Are you able to empty a urine collection bag, or do you have someone who can help you?
Do you not have active infections, wounds, or severe irritation around your genital area?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, the first step involves looking back at the last month to see how often you had problems with your current catheter. After this, you'll have one week to get used to the PureWick™ System. During this time, you and anyone who helps you will get training on how to use it properly.

Once you're comfortable, you'll then use the PureWick™ System at home for four weeks. During this period, researchers will check in with you to see how it's working regarding urine collection, your comfort, sleep, and overall well-being. The total duration of your active participation, after the initial look-back, will be about five weeks.

Potential risks and benefits

Taking part in this study could offer some benefits, such as potentially finding a more comfortable and effective way to manage urine leakage, especially if your current catheter causes problems. However, as with any new treatment or device, there might be some risks or side effects, although these will be carefully monitored. The study will assess if the external device works as well as, or better than, an internal catheter. Remember, you can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

NCAS- Northamptonshire Continence Advisory Service
Verified postcode
Northampton, United Kingdom

Common questions

What is urinary incontinence?

It's when you accidentally leak urine, which can be a small dribble or a sudden gush. It's a common condition that affects many women.

What is the PureWick™ System?

It's a device that sits outside the body to collect urine, designed as an alternative to catheters that are placed inside the body.

What are 'problematic catheters'?

This means your current internal catheter has been causing issues, requiring you to seek help from a doctor or nurse at least five times in the last month.

Will I have to pay to be in the study?

No, you will not have to pay to participate in this study. The device and study-related care are provided.

Can my family help me with the device?

Yes, if you have caregivers, they will also receive training on how to help you use the PureWick™ System.

How to find out more

Winfried Huesmann

winfried.huesmann@bd.com +4915154403197 Official trial record

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