Not yet recruitingNAINTERVENTIONAL

Tensi+ for Treating Overactive Bladder

This study is investigating a new device called Tensi+ for people who experience symptoms of overactive bladder (OAB). OAB can make you feel a sudden, strong need to urinate frequently, sometimes leading to accidental leaks. Tensi+ works by sending gentle electrical pulses to a nerve in your leg, called Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS), which can help calm the bladder. Researchers want to see if Tensi+ is safe and effective in reducing these uncomfortable OAB symptoms. The goal is to find out if this device can help people regain better control of their bladder and improve their daily life.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Stimuli Technology

Enrolment target

Start

01 May 2026

Estimated completion

01 Jan 2027

Overactive Bladder (OAB)

What is this study about?

This study is researching a new way to help people who have overactive bladder, often called OAB. If you have OAB, you might feel a sudden, strong urge to go to the toilet often, and sometimes you might not make it in time, leading to leaks. These symptoms can really affect your daily life and can be quite frustrating.

The study is focusing on a device called Tensi+. This device uses a gentle treatment called Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS). This involves putting small pads on your skin near a nerve in your ankle. These pads then send very mild electrical pulses to the nerve. The idea is that stimulating this nerve can help to calm down the signals going to your bladder, making it less overactive. Doctors want to see if Tensi+ can safely and effectively reduce how often you feel the urge to go, how often you actually go, and if it can help stop those unexpected leaks.

By taking part, you could help doctors understand if Tensi+ is a good option for others experiencing similar symptoms. This kind of research is really important because it helps develop new and better treatments to improve people's health and quality of life.

Key takeaways

The study explores Tensi+ for overactive bladder symptoms.
Uses gentle electrical pulses near the ankle to calm bladder activity.
Aims to reduce urges, frequency of urination, and leaks.
Participation involves device use, clinic visits, and bladder diaries.
It could offer symptom relief, but results are not guaranteed.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, 22 years old or older, and have been diagnosed with overactive bladder (OAB) symptoms for at least three months. These symptoms should include feeling a strong urge to urinate at least twice a day, and needing to urinate frequently (11 or more times a day), as shown in your bladder diary recordings.

There are also some reasons why you might not be able to join. For example, if you have a pacemaker or other electronic device implanted in your body, or if you are pregnant or planning to become so. We also can't include people with certain health conditions like problems with excessive bleeding, nerve damage that could affect the treatment, or issues with your ankle where the treatment device would be placed. If you have severe diabetes, certain nerve conditions like Multiple Sclerosis, or frequent urinary tract infections, you also wouldn't be able 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.

Are you 22 years old or older?
Have you had overactive bladder symptoms for at least 3 months?
Do you experience a strong urge to urinate two or more times a day?
Do you urinate 11 or more times a day?
Do you NOT have a pacemaker or other implanted electronic device?
Are you NOT pregnant or planning pregnancy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have an initial check-up to make sure you're suitable. Once enrolled, you will use the Tensi+ device as instructed by the study team. You'll likely have regular appointments at the study clinic or hospital where the team will monitor your progress, check the device, and ask about your symptoms and how you are feeling. You will also be asked to keep a record of your bladder habits, often called a bladder diary. The total length of your participation in the study, including all treatments and check-ups, will be explained fully by the research team. At any point, you are free to stop taking part if you change your mind.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as a reduction in your overactive bladder symptoms and an improvement in your quality of life. However, there's no guarantee that the Tensi+ device will work for everyone, and it might not help your symptoms. As with any medical device, there could be some risks or side effects, such as skin irritation where the pads are placed, or discomfort from the electrical pulses, though these are usually mild. The research team will explain all known potential risks to you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Cedars-Sinai
Verified postcode
Beverly Hills, United States
NYU Langone Health
Verified postcode
New York, United States
Toronto Western Hospital
Verified postcode
Toronto, Canada

Common questions

What is Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS)?

It's a gentle treatment where mild electrical pulses are sent through your skin to a nerve in your ankle to help calm your bladder.

Will the treatment be painful?

The electrical pulses are usually described as a tingling sensation, not painful. The study team will make sure you are comfortable.

How often will I need to use the Tensi+ device?

The exact schedule for using the device will be given to you by the study team as part of the study plan.

What if I have another health condition?

Some health conditions or implanted devices mean you can unfortunately not take part, as explained in the eligibility section.

Can I continue my regular OAB medication during the study?

You might need to stop certain OAB medications before or during the study. This will be discussed with you by the study team.

How to find out more

Akshaya Mariadassou

a.mariadassou@stimuli-technology.com +331 84 60 48 25 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.