Feasibility and tolerability of 28 days intravaginal oxybutynin via the MedRing OAB system
This study is investigating a new treatment for women who experience overactive bladder. This condition causes a sudden, strong urge to urinate more often than usual, which can be disruptive. The study will test a device called the MedRing OAB system. This is a small ring that is inserted into the vagina and designed to release a medicine called oxybutynin slowly over 28 days. Researchers want to find out if this new ring is safe, easy to use, and comfortable for women. This is a very early-stage study, meaning it's one of the first times this specific treatment method is being tested in people to see how it works in the body.
At a glance
What is this study about?
This study is focusing on a common bladder problem called overactive bladder. If you have this, you might feel a sudden, strong need to go to the toilet, even if your bladder isn't full, or you might need to go much more often than others. It can sometimes lead to urine leakage and can be quite upsetting.
The usual treatments for overactive bladder can sometimes have side effects that make them difficult to use. This research is exploring a new approach, specifically for women. It involves a small ring, similar to a contraceptive ring, that you place yourself into the vagina. This ring is designed to slowly release a medication called oxybutynin directly where it might be most helpful for your bladder.
The main goal of this particular study is to see how safe and comfortable this new system (the MedRing OAB) is to use for 28 days. It's a very early study, meaning it's one of the first times this method is being tried in women. The researchers are looking at things like whether it causes any irritation and how well women can tolerate using it. This is an important फर्स्ट step in seeing if this new way of delivering medication could become a helpful option for women with overactive bladder in the future.
Key takeaways
- This study is testing a new way to treat overactive bladder in women.
- It involves a small vaginal ring that releases medicine (oxybutynin) for 28 days.
- The main aim is to check if the ring is safe and comfortable to use.
- It's an early-stage study, meaning it's one of the first times it's being tested in people.
- Only women aged 18 and over can take part.
Who may be eligible?
This study is specifically designed for women aged 18 years or older. Anyone younger than 18, or anyone assigned male at birth, would not be able to join this particular study.
The researchers have certain health requirements that you would need to meet to ensure your safety in the study. These details would be discussed in full with you by the study team, typically during an initial screening visit.
It's important to remember that even if you meet the basic age and sex requirements, there might be other medical reasons why you couldn't take part. This is normal for all clinical studies, as it helps create the safest possible environment for participants.
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 female?
- Are you 18 years old or older?
- Do you have a diagnosis of overactive bladder?
- Are you comfortable with using a vaginal ring device?
- Are you able to attend study visits for about a month?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to make sure it's safe for you to participate. If eligible, you would receive the MedRing OAB system and be shown how to insert it yourself. You would use this ring continuously inside your vagina for 28 days.
Throughout these 28 days, you would likely have a few appointments or check-ins with the study team. These visits would involve health assessments, where doctors would check on your overall well-being and ask about any new symptoms or side effects. They might also ask you to complete questionnaires about your experience with the ring, including how comfortable it is and if you had any difficulties. At the end of the 28 days, the ring would be removed, and you would have a final follow-up visit to ensure everything is well. The total duration of your active involvement in the study would be approximately one month, including follow-up.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is overactive bladder?
Overactive bladder is a condition where you feel a sudden, strong need to urinate, often more frequently than usual, and sometimes with difficulty holding it in.
What is the MedRing OAB system?
It's a small ring that you place in the vagina, designed to slowly release medication (oxybutynin) directly to help treat overactive bladder over 28 days.
Is this a new medicine?
Oxybutynin is not new, but using it through this specific vaginal ring system is a new way of delivering the medicine, which this study is testing.
How long would I be in the study?
You would use the ring for 28 days, with a few visits before, during, and after, making the total study involvement around one month.
Do I have to pay to join?
No, participating in a clinical trial like this means all study-related treatments and assessments are usually provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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