RecruitingNAINTERVENTIONAL

Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

This research study, called 'Augmenting Urinary Reflex Activity Study 4', is investigating a new way to help women with bladder control issues, specifically those who experience both leaking urine when they cough or sneeze (stress incontinence) and a sudden, strong need to urinate (urge incontinence), or constant pelvic pain. The treatment involves a small device called Picostim™ II, which is gently placed under the skin. This device sends very mild electrical pulses to nerves that control the bladder. The main goals are to check if this new treatment is safe and if it can help improve bladder problems in women who haven't had success with other treatments. This is an early-stage study to understand how well the device works and if it could be a helpful option in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Amber Therapeutics Ltd

Enrolment target

Start

24 Jun 2025

Estimated completion

01 Jan 2030

Mixed Urinary Incontinence Stress Urinary Incontinence (SUI)Chronic Pelvic Pain Urge Urinary Incontinence

What is this study about?

Many women experience problems with bladder control, which can be upsetting and impact daily life. These problems can include leaking urine when you cough, sneeze, or exercise (this is called stress incontinence), or a sudden, strong urge to go to the toilet that's hard to hold in (called urge incontinence). Sometimes, women experience both types, which is known as mixed urinary incontinence. There's also chronic pelvic pain, which can be related to bladder issues.

This study is looking into a new treatment that might help with these conditions. It's called 'pudendal neuromodulation' and involves a small, implanted device, Picostim™ II. This device works by sending very gentle electrical signals to specific nerves that play a role in how your bladder works. The idea is to help these nerves and muscles work better, which could improve bladder control and reduce symptoms.

The main purpose of this research is to see if this new treatment is safe to use and if it can effectively help women who haven't found relief from other common treatments. It's an exploration into a personalised approach, meaning the treatment might be adjusted to fit each person's needs. If successful, this type of treatment could offer a new option for better bladder control and improved quality of life.

Key takeaways

This study is testing a new implanted device to help women with bladder control issues.
It's for women who have both leaking urine and a strong urge to go, and other treatments haven't worked.
The device sends gentle electrical pulses to nerves that control the bladder.
The main goals are to check if the treatment is safe and if it helps improve symptoms.
Participation involves a small surgery, follow-up visits, and learning to use the device.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is particularly for women who are at least 22 years old and were born female. You would be considered if you have been experiencing both leaking urine (when you cough or sneeze) and a strong urge to go to the toilet that’s hard to hold, for at least six months. It’s important that you’ve already tried other common treatments for your bladder problems, but they haven't worked well for you, or you couldn't tolerate them.

There are also some reasons why you might not be able to join. For instance, if you are pregnant, breastfeeding, or planning to become pregnant anytime in the future, this study isn't suitable. You also wouldn't be able to take part if you have certain health conditions like uncontrolled diabetes, a recent history of cancer (within the last 5 years), or certain major psychiatric or neurological conditions like Parkinson's disease or multiple sclerosis.

Also, if you are taking blood-thinning medications, this study might not be right for you. The researchers need to make sure you are able to attend all study visits, comfortably use the implanted device after training, and give your full permission to take part.

Quick self-check

Are you a woman, at least 22 years old, who was born female?
Do you experience both leaking urine when you cough/sneeze AND a strong, sudden urge to go to the toilet?
Have you tried other treatments for your bladder problems without enough success or couldn't tolerate them?
Have your bladder issues lasted for at least six months?
Are you NOT pregnant, breastfeeding, or planning to become pregnant?
Do you NOT have a recent history of cancer (within 5 years) or certain significant neurological or psychiatric conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll first have some initial checks to see if you're a good fit. If you are, you'll have a small device, Picostim™ II, surgically placed under your skin. This device provides a gentle electrical stimulation to nerves that help your bladder. You'll be trained on how to use it.

Throughout the study, you will have several clinic visits where the team will monitor your progress, check the device, and make any necessary adjustments. They will also ask you questions about your bladder control and how you are feeling. You'll need to be able to come to all these appointments and openly share information about your symptoms. The total duration of the study isn't specified, but it will involve ongoing follow-up after the device implantation.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as improved bladder control and a better quality of life if the new treatment works for you. You would also be contributing to medical research that could help many other women in the future. However, there are potential risks, as with any medical procedure or new treatment. These could include risks associated with having a small surgery, like infection or discomfort around the device site, or the device not working as expected. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

UZ Leuven
Leuven, Belgium· Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Belgium· Recruiting
Ghent University Hospital
Ghent, Belgium· Recruiting
Maastricht UMC
Maastricht, Netherlands· Recruiting
Southmead Hospital
Bristol, United Kingdom· Recruiting
University College London Hospital
London, United Kingdom· Recruiting
Guy's Hospital
London, United Kingdom· Not yet recruiting

Common questions

What is mixed urinary incontinence?

It's when you have two types of bladder control problems at the same time: leaking urine when you cough or sneeze, and also a sudden, strong urge to go to the toilet that's hard to hold.

What is pudendal neuromodulation?

It's a treatment that uses gentle electrical pulses from a small device, placed under your skin, to send signals to the nerves that control your bladder, helping it work better.

Is the device permanent?

The study involves an implanted device. The researchers will assess its performance and safety over time. If you become pregnant during or after the study, you would need to turn off the device for the whole pregnancy.

Will this improve my bladder control right away?

This is an exploratory study, so there's no guarantee, and improvements can take time. The aim is to see if this treatment can help improve bladder function over time.

What if I get pregnant during the study?

If you plan to become pregnant, are pregnant, or breastfeeding, you cannot join the study. If you become pregnant during the study, you would need to turn off the device for the entire pregnancy period.

How to find out more

Amber Clinical Affairs

AURA-4X@amber-tx.com 08000418515 Official trial record

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