Tensi+ European Registry
This study, called the Tensi+ European Registry, is for people with overactive bladder. Researchers are gathering information about a new device called Tensi+, which uses gentle electrical stimulation on the ankle to help manage bladder symptoms. Previous small studies have suggested it's safe and helpful. This larger study aims to collect real-world data from many patients over a full year to get a better understanding of how effective and safe Tensi+ truly is. They also want to identify what might make the treatment more successful for some people than others. The goal is to provide valuable insights into managing overactive bladder with this new technology.
At a glance
What is this study about?
This study is called the Tensi+ European Registry, and it's all about a condition called overactive bladder. If you have overactive bladder, you might feel a sudden, strong need to pee, often, and sometimes struggle to hold it. This can really affect your daily life.
The study is looking at a new device called Tensi+. This device uses a gentle electrical stimulation on a nerve near your ankle to help with your bladder symptoms. Think of it like a very mild, non-painful tingling feeling. While some early studies have suggested that Tensi+ is safe and might help, researchers now want to gather more information from a large number of people in a real-world setting.
Over the course of a year, the study will collect details on how well the Tensi+ device works for different people and if it causes any side effects. This information is really important because it will help doctors understand who might benefit the most from this treatment and how best to use it to improve patients' lives.
Key takeaways
- This study evaluates Tensi+, a new device for overactive bladder.
- It aims to understand how well and safely Tensi+ works in real-world use.
- Participants must be over 18 with overactive bladder.
- Certain medical conditions or implants prevent participation.
- The study lasts one year and involves using the device and recording symptoms.
- You can leave the study at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old and have been diagnosed with overactive bladder, whether it's the kind that doesn't have a clear cause (idiopathic) or the kind linked to a nerve condition.
There are some reasons why you wouldn't be able to join. For example, if you have certain electronic implants like a pacemaker or defibrillator, or if you have metal implants very close to where the device would be used. Pregnant women also cannot take part.
Additionally, if you have ankle problems, swollen ankles, or any skin issues in the area where the device would be placed, you wouldn't be suitable. If you have difficulty understanding instructions, are unable to keep a diary of your bladder habits, or (in some countries) don't have social security cover, you wouldn't be able to participate.
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 18 years old or older?
- Do you have overactive bladder?
- Do you NOT have a pacemaker, defibrillator, or similar electronic implant?
- Are you NOT pregnant?
- Do you NOT have serious skin problems or metal implants near your ankle?
- Are you able to keep a simple diary of your bladder habits?
What does participation involve?
If you join the study, you'll be using the Tensi+ device as prescribed for your overactive bladder. The study will last for a total of one year. During this time, you'll be asked to provide information about your symptoms and how you're feeling. This will likely involve completing questionnaires or surveys, and you'll need to keep a diary to record your bladder habits. There may be occasional visits to your healthcare provider to check on your progress and ensure the treatment is working well and safely. The exact number of visits or assessments will be explained to you by the study team.
Potential risks and benefits
Locations (17)
- HFME - Hospices Civils de LyonVerified postcodeBron, France· Recruiting
- CHU de RennesVerified postcodeRennes, France· Recruiting
- CHU de RennesVerified postcodeRennes, France· Recruiting
- CHU de Rouen - Hôpital Charles NicolleVerified postcodeRouen, France· Recruiting
- Nuova Villa EstherVerified postcodeAvellino, Italy· Not yet recruiting
- Azienda Ospedaliero-Universitaria CareggiVerified postcodeFlorence, Italy· Not yet recruiting
- Hesperia HospitalVerified postcodeModena, Italy· Not yet recruiting
- Santa Maria la Gruccia HospitalVerified postcodeMontevarchi, Italy· Not yet recruiting
- Policlinico Tor VergataVerified postcodeRoma, Italy· Not yet recruiting
- Casa di Cura Villa StuartVerified postcodeRoma, Italy· Not yet recruiting
- Villa Salaria HospitalVerified postcodeRoma, Italy· Not yet recruiting
- Azienda Ospedaliero Universitaria Sant'AndreaVerified postcodeRoma, Italy· Not yet recruiting
Common questions
What is overactive bladder?
Overactive bladder is when you suddenly feel a strong urge to pee, often needing to go frequently, and sometimes struggling to hold it in.
What is Tensi+?
Tensi+ is a new device that uses gentle electrical stimulation on a nerve near your ankle to help manage the symptoms of overactive bladder.
How long will the study last?
The study will collect information over a total period of one year.
Will I need to visit the clinic often?
You will likely have some visits to your healthcare provider to check on your progress, but the exact schedule will be explained further by the study team.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time without it affecting your normal medical care.
How to find out more
Akshaya Mariadassou
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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