An exploratory, prospective, multicenter, randomized, double blind, placebo + sham device controlled, study to assess the safety, usability, and initial efficacy of the ViXe combination for intravesical administration of XEOMIN® in the treatment of female patients with idiopathic overactive bladder (OAB).
This research is investigating a new treatment called ViXe for women who experience bothersome symptoms of overactive bladder (OAB). OAB can cause a sudden, strong need to urinate, and sometimes lead to accidental urine leakage. The study aims to find out if this new combination treatment, given directly into the bladder, is safe and easy for doctors to use. Researchers also want to see if it makes a difference to OAB symptoms. Participants will receive either the active treatment or a dummy treatment (placebo) to fairly compare their effects. This is an early-stage study, meaning we are learning the basics about this potential new medicine.
At a glance
What is this study about?
Imagine you have an overactive bladder, meaning you often feel a sudden, strong urge to pee, sometimes without much warning. This study is looking into a new way to help with these symptoms. It's called 'ViXe combination' and involves a medicine similar to one you might have heard of, called XEOMIN®, being given directly into the bladder.
The main goals of this research are to figure out if this ViXe combination is safe for women with overactive bladder and how easy it is for doctors to give. We also want to get an early idea of whether it actually helps to improve symptoms like how often you need to go to the toilet, the urgency you feel, or if you accidentally leak urine. By understanding these things, we can see if this treatment might be a good option for people with overactive bladder in the future.
This is an early-stage study, sometimes called Phase II. This means it's one of the first times this specific treatment combination is being tested in a group of people. We're carefully examining its initial effects before potentially moving on to larger studies. Participants will be randomly given either the active treatment or a placebo (an inactive substance or dummy treatment) to ensure we can fairly compare the results and understand the true effects of the ViXe combination.
Key takeaways
- This study is for women with overactive bladder (OAB).
- It's testing a new combination treatment given directly into the bladder.
- The main goals are to check safety, ease of use, and early effectiveness.
- Participants will receive either the active treatment or a placebo.
- The study involves follow-up appointments and symptom tracking over 12 weeks.
- Your participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for women who are at least 18 years old and have been diagnosed with overactive bladder. This means you experience symptoms like a sudden and strong urge to urinate, often leading to unexpected trips to the toilet, or sometimes even accidental urine leakage.
Because this is a specific type of study, there will be other medical checks and criteria that determine if this study is right for you. These checks are put in place to make sure the study is safe for everyone involved and that the results are as clear as possible.
If you're interested, the research team will carefully review your medical history and current health to see if you meet all the necessary requirements to take part.
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.
- Am I a woman aged 18 or older?
- Do I have symptoms of overactive bladder (like urgency or leaks)?
- Am I able to attend regular appointments for about 12 weeks?
- Am I willing to potentially receive a 'dummy' treatment (placebo)?
- Am I comfortable keeping a short diary about my bladder symptoms?
What does participation involve?
If you decide to join this study, you would be randomly assigned to receive either the active ViXe treatment or a 'dummy' treatment (placebo). Neither you nor your study doctor would know which one you are receiving – this is to make sure the results are fair.
The treatment would involve a procedure where the medicine is given directly into your bladder. After this, you would have several follow-up visits or checks over about 12 weeks to see how you are doing. During these visits, the research team will ask you questions about your symptoms and may ask you to fill out questionnaires. You might also be asked to keep a diary for a few days to track things like how often you go to the toilet and if you experience any leaks. The total time you would be involved in the study would be approximately 12 weeks.
Potential risks and benefits
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Common questions
What is overactive bladder (OAB)?
OAB is a condition where you feel a sudden, strong need to urinate, sometimes frequently, and you might accidentally leak urine.
What is XEOMIN®?
XEOMIN® is a medicine that can help relax muscles. In this study, a similar medicine is being tested for use in the bladder to help with OAB symptoms.
Why is a 'placebo' used?
A placebo is a 'dummy' treatment with no active medicine. It helps researchers fairly compare results and understand if the active treatment truly works better than nothing.
How long will I be in the study?
If you join, your participation in the study would last for about 12 weeks after you receive the treatment.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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