CompletedPhase IIInterventional

Tibial nerve stimulation to improve bladder symptoms in Parkinson's

Bladder problems, such as needing to rush to the toilet or waking up often at night, affect many people living with Parkinson’s. While medicines exist, they can sometimes cause unwanted side effects like dry mouth or confusion. Researchers at the University of Bristol are testing a drug-free alternative called the Geko device. This is a small, sticky patch worn on the lower leg that sends gentle electrical pulses to the tibial nerve, which helps calm the bladder. In this 12-week study, half of the participants will use the active stimulation, while the other half will use a lower strength that does not affect the bladder. Participants use the device at home for 30 minutes, twice a week. You will also visit a clinic in Bath twice for bladder tests and complete short questionnaires at home.

At a glance

Status

Completed

Phase

Phase II

Sponsor

University of Bristol

Enrolment target

220

Start

02 Sep 2021

Estimated completion

09 Jun 2023

Bladder symptoms in Parkinson's

What is this study about?

Parkinson’s disease affects movement, but it also frequently disrupts how the bladder works. Many people experience an overactive bladder, which causes sudden urges to pee, frequent daytime and night-time toilet trips, and accidental leaks. These symptoms can be distressing, disrupt sleep, and increase the risk of trips and falls around the house.

Doctors often prescribe medications for bladder issues, but in people with Parkinson’s, these drugs can cause challenging side effects, including memory problems or constipation. This study, called the STRIPE trial, looks at whether gentle nerve stimulation through the skin can provide relief without the need for additional pills.

The trial tests a small, battery-powered patch called the Geko device. Placed on the lower leg, it delivers mild electrical pulses to the tibial nerve. Because this nerve shares pathways with the nerves controlling the bladder, stimulating it can help settle bladder spasms. Half of the people in the trial will receive active stimulation, and half will receive a very low level that acts as a comparison.

By comparing the two groups over 12 weeks, the researchers hope to show whether this home-based device genuinely improves bladder control. If successful, it could offer a safe, comfortable, and drug-free way to improve quality of life for people with Parkinson’s.

Key takeaways

Tests a simple, wireless stick-on device (Geko) worn on the lower leg to calm overactive bladder symptoms.
A drug-free approach aimed at avoiding the side effects of traditional bladder tablets.
Treatment is completed at home for 30 minutes, twice a week, over a 12-week period.
Involves two in-person visits to the Royal United Hospital in Bath for bladder checks.
Half of the participants receive active stimulation, while half receive a low-strength comparison setting.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with standard Parkinson’s disease (sometimes called idiopathic Parkinson’s) and are experiencing bothersome bladder symptoms. You must be able to understand what the trial involves and make your own decision to take part.

You cannot take part if your Parkinson-like symptoms are caused by other conditions, such as progressive supranuclear palsy (PSP) or multiple system atrophy (MSA). People diagnosed with dementia, those with a history of bladder or prostate cancer, or anyone who has recently started new bladder medications are also not eligible.

For safety reasons, you cannot join if you have an implanted electronic device, such as a heart pacemaker. You must also have at least one healthy lower leg where the sticky device can be comfortably attached.

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.

I am aged 18 or older.
I have been diagnosed with standard (idiopathic) Parkinson’s disease.
I have bothersome bladder issues, such as sudden urges or frequent urination.
I do not have a pacemaker or any other implanted electronic device.
I do not have a diagnosis of dementia.
I am able to travel to the Royal United Hospital in Bath twice for health checks.

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts around 12 weeks. You will be randomly placed into one of two groups by chance, like flipping a coin. One group uses the device with active nerve stimulation, while the other group uses it at a lower setting. You will use the small Geko device on your lower leg at home for 30 minutes at a time, two days per week. Because the device is self-adhesive and wireless, you can relax without trailing cords.

You will need to make two visits to the research clinic at the Royal United Hospital in Bath: one before you begin the 12-week treatment and one just after you finish. During these visits, the medical team will carry out detailed bladder tests to measure how well your bladder holds urine. Every other week at home, you will also complete a brief questionnaire to track your bladder symptoms. There are no study tablets to swallow, and you will be supported by the study team throughout.

Potential risks and benefits

You may experience improvements in your bladder symptoms, such as fewer urgent trips to the toilet, but this cannot be guaranteed—especially if you are placed in the low-stimulation group. However, your participation will help doctors find safer, non-drug treatments for Parkinson’s in the future. The Geko device is already approved in the UK for other medical uses, and risks are very low. The most common side effect is mild, temporary skin redness or itching under the sticky pad. There are no trailing wires, which helps prevent trips or falls. Joining is entirely your choice, and you can withdraw at any point without your standard NHS medical care being affected.

Locations (1)

RICE
Approximate
Bath, England

Common questions

Does the nerve stimulation hurt?

No. Most people feel a mild tingling, buzzing, or pulsing sensation in their lower leg or foot, but it should not be painful.

Will I know which stimulation strength I am getting?

No. To keep the results fair and unbiased, neither you nor the study team will know whether your device is set to the active or lower comparison strength.

Do I have to travel to the hospital every week?

No. You use the device at home twice a week. You only need to travel to the Royal United Hospital in Bath twice: once at the start and once at the end.

Can I continue taking my regular Parkinson’s medication?

Yes. You should continue your routine Parkinson's treatments as prescribed by your doctor throughout the trial.

What happens if the sticky pad irritates my skin?

Skin redness is rare and usually mild. If you notice persistent discomfort or irritation, you can remove the patch and contact the study team for guidance.

How to find out more

Matthew Smith

matthew.smith@bristol.ac.uk +44 117 428 3112 Official trial record

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