e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
This study is gathering information about a new type of tube, called an e-Sense® catheter, used in a bladder test called urodynamics. Doctors use urodynamics to check how your bladder and the tubes that carry urine work. We want to find out what the ‘normal’ pressure readings should be when using these e-Sense® catheters. This helps doctors properly interpret your test results and understand if your bladder is functioning typically. If you're having a urodynamic test anyway, you might be asked to take part. The study will compare how different catheters measure these pressures and use the information to help other doctors accurately use the e-Sense® system in the future. Your personal test results will still be used to help your doctor decide on the best care for you.
At a glance
What is this study about?
Imagine your bladder is like a balloon that fills with liquid. When doctors need to check how well your bladder is working, they might do a test called 'urodynamics'. This test uses very thin tubes, called catheters, to measure the pressure inside your bladder as it fills and empties.
This particular study is like a 'quality check' for a new type of catheter called e-Sense®. The main goal is to figure out what the *normal* pressure readings should look like when using these e-Sense® catheters. Think of it like setting the standard for how this new tool should work. By understanding what 'normal' pressures are, doctors can better tell if someone's bladder is working correctly or if there might be a problem.
If you take part, you'll be having a urodynamic test as you normally would for your bladder symptoms. The study will simply use the e-Sense® catheters to collect extra information during your test. This extra information will help the company that makes the catheters understand them better and share that knowledge with other doctors. Don't worry, your own test results will still be used by your doctor to help you.
Key takeaways
- The study helps doctors understand a new bladder test tool (e-Sense® catheter).
- It aims to find 'normal' pressure readings for these catheters.
- Participation involves your already planned bladder test, with no extra visits.
- Your individual test results will still guide your personal medical care.
- You can stop participating at any time without affecting your treatment.
Who may be eligible?
This study is looking for both men and women who are already having a special bladder test called a urodynamic procedure. You need to be either between 20 and 35 years old, or over 50 years old.
For women in the younger age group (20-35), you should not have had any children. If you are over 50, you should have given birth at least once naturally (vaginally). Having had a C-section would not stop you from joining.
There are also some reasons you wouldn't be able to join. For example, if you have certain thinking or mental health conditions that make it hard to understand or talk about the study, or if you are pregnant. You also can't join if you have ongoing bladder infections that haven't been treated, or if you have certain bowel problems or have had recent bowel surgery. Your doctor will check if you fit all the requirements.
- Are you already scheduled for a urodynamic bladder test?
- Are you between 20-35 years old, or over 50?
- If you're a woman aged 20-35, have you never given birth?
- If you're a woman over 50, have you given birth naturally (vaginally) at least once?
- Do you not have an active, untreated bladder infection?
- Are you able to clearly understand and discuss the study information?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you won't need any extra visits beyond your planned urodynamic test. During this single appointment, two very thin tubes (catheters), including the e-Sense® one, will be gently placed. Pressures will be measured while you lie down, sit, and stand, both before and during your bladder filling up. No extra medications are involved. The total duration of your involvement will be just that single urodynamic test appointment.
Potential risks and benefits
Locations (1)
- Bristol Urological InstituteBristol, United Kingdom· Recruiting
Common questions
What is a urodynamic test?
It's a test to check how well your bladder and the tubes that carry urine work, especially when you have bladder symptoms like needing to go often or leaking.
Will this study change my medical treatment?
No, your doctor will still use your test results to decide on the best care for you. The study just uses extra information from your test for research purposes.
Do I have to do anything extra if I join?
No, you just attend your scheduled urodynamic test. The study will collect information during that single appointment.
Is the e-Sense® catheter safe?
Yes, it's a type of catheter already used in healthcare. This study is about understanding its normal readings better.
Can I leave the study if I change my mind?
Absolutely, you can withdraw at any point without it affecting your medical care or relationship with your doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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