Active not recruitingNAINTERVENTIONAL

Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI

This study is testing a new mobile app called Oups! and a small, connectable device to help older women manage bladder leaks, also known as urinary incontinence (UI). Many women over 55 experience UI, but often don't seek help due to cost or difficulty getting to appointments. This project aims to see if these new digital tools are easy to use, whether women like them, and if they can improve bladder control and overall well-being. The device helps measure how well pelvic floor muscles are working, and the app guides exercises. By making treatment more accessible and private, this research hopes to help more women take control of their bladder health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Enrolment target

Start

13 Jan 2025

Estimated completion

31 Dec 2027

Urinary Incontinence (UI)Urinary Stress Incontinence Telehealth

What is this study about?

Many women, especially those over 55, experience bladder leaks, a condition doctors call urinary incontinence (UI). It can be embarrassing and affect daily life, but it's actually quite common. The good news is that exercises for your pelvic floor muscles, which support your bladder, are a very effective first step in treating UI. However, sometimes it's hard for women to get to clinics for help, or find treatment that fits into their budget.

This research project is looking at a new way to help. It's testing a special mobile app called Oups! alongside a small, smart device. The Oups! app is designed to guide women through their pelvic floor muscle exercises. The connected device is like a personal trainer, measuring how well your muscles are doing during these exercises and giving you feedback. Together, they aim to offer a convenient, private, and cost-effective way to manage UI from the comfort of your home.

The main goals of this study are to find out three things: first, if the Oups! app is easy and straightforward for older women to use; second, if the connected device is also easy to use and liked by participants; and third, if using these tools actually helps lessen bladder leaks, makes women feel better, and improves their pelvic floor muscle strength.

Key takeaways

This study is for women over 55 with certain types of bladder leaks.
It tests a new app and device for pelvic floor muscle training at home.
The goal is to make bladder leak treatment easier and more accessible.
You need to be able to use a mobile phone or tablet.
Your feedback will help improve future digital health tools.
Participation involves several assessments and using the tools at home.

Who may be eligible?

This study is looking for women aged 55 or older who experience bladder leaks when they cough, sneeze, laugh, or exercise (this is called stress urinary incontinence), or a mix of these leaks and sudden urges to go (mixed urinary incontinence). You should have leaks at least three times a week.

To join, you need to be able to walk safely on your own, understand simple instructions in French (both spoken and written), and have some basic familiarity with using a tablet or mobile phone. You also need to be able to do pelvic floor muscle contractions correctly and be willing to have a gynaecological exam.

You won't be able to join if your bladder leaks are mostly due to sudden, strong urges to go to the toilet (urge incontinence), or if you have certain health problems like a neurological condition, severe pelvic organ prolapse, or other serious health issues that might prevent you from using the app or device. Also, if you’ve had treatment for bladder leaks in the last year, or take medicines that might affect the study, you probably won't be suitable.

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 55 or older?
Do you have bladder leaks when you cough, sneeze, laugh, or exercise, at least 3 times a week?
Can you understand simple French instructions, both spoken and written?
Are you able to use a tablet or mobile phone a bit?
Are you willing to have a gynaecological exam?
Have you *not* had treatment for bladder leaks in the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a phone call where we'll ask you some questions about your health and bladder habits to see if you're a good fit. You'll also keep a short diary of your bladder leaks for seven days. If you meet the initial criteria, you'll come in for a 1.5-hour assessment before starting the main part of the study. The study involves using the Oups! app and the connected device for your pelvic floor muscle training at home. The researchers will check in with you and look at how well the app and device are working, as well as how your bladder leaks and quality of life are changing. The total duration of your participation will be explained in detail.

Potential risks and benefits

Participating in this study might offer you the benefit of learning to better manage your bladder leaks using new technology, potentially improving your quality of life. As with any study, there's always a small chance of discomfort or inconvenience, for example, during assessments or getting used to the new technology. You will receive clear instructions and support throughout. Remember, taking part in any research is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Women's Health and Aging Laboratory - CRIUGM
Verified postcode
Montreal, Canada

Common questions

What is urinary incontinence (UI)?

UI is when you accidentally leak urine. This study focuses on leaks that happen when you cough, sneeze, laugh, or exercise.

What are pelvic floor muscles?

These are the muscles that support your bladder, womb, and bowel. Keeping them strong can help control bladder leaks.

Do I need to be good with technology?

You'll need a basic understanding of how to use a tablet or mobile phone, but the app is designed to be user-friendly.

Will I have to pay for anything?

Taking part in the study should not cost you anything directly related to the research tools or assessments.

How long will the study last?

The team will tell you the exact duration of your participation during the initial screening call.