AuthorisedTherapeutic use (Phase IV)Interventional

Treatment of Chronic Anal Fissure with Ultrasound-Guided Inter-Sphincteric Injections of Botulinum Toxin A

This study investigates a treatment for chronic anal fissures, which are long-lasting tears in the back passage that can cause a lot of pain. Doctors are using an injection of Botulinum Toxin A, commonly known as Botox, delivered using ultrasound to guide it precisely. This particular study is in a later stage (Phase IV), meaning the treatment has already been used and found safe, and now researchers are looking at its effectiveness in real-world settings. They will be measuring how much pain people feel, how well they manage their bowel movements, and how their quality of life changes. The aim is to find out if this injection is a good way to help people with chronic anal fissures feel better.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital Universitario de Burgos

Enrolment target

Start

22 Jan 2025

Chronic anal fissure

What is this study about?

Imagine you have a small tear in the lining of your back passage, like a cut on your skin that just won't heal. This is called an anal fissure, and when it lasts a long time (more than six weeks), it's called a chronic anal fissure. It can be very painful, especially during and after going to the toilet, and can significantly affect your daily life.

This study is testing a treatment that uses a medicine called Botulinum Toxin A, often known as Botox. You might have heard of Botox being used for wrinkles, but it's also used in medicine to relax muscles. In this case, doctors will carefully inject it into a specific muscle around the back passage. They will use a special ultrasound scan to make sure the injection goes in exactly the right place.

The main aim of this research is to see how well this Botox injection works at easing the pain caused by chronic anal fissures. They also want to understand if it helps people manage their bowel movements better and improves their overall quality of life. This is a later-stage study, which means the treatment has already been checked for safety, and now doctors want to gather more information about its benefits in a wider group of patients.

Key takeaways

This study uses Botox injections to treat long-lasting anal fissures.
It aims to reduce pain and improve quality of life.
Ultrasound guidance is used for precise injection.
They will measure pain, bowel control, and quality of life.
It's for adults with chronic anal fissures, regardless of gender.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older, and your gender doesn't matter – both men and women can take part. The main condition for joining is that you must have a long-lasting anal fissure, which is a tear in the back passage that has been present for a while.

The research team will carry out some checks to make sure this study is right for you and that taking part would be safe. They'll review your medical history and current health to ensure you meet all the necessary requirements for the study.

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?
Have you been diagnosed with a chronic anal fissure (a tear in your back passage that hasn't healed quickly)?
Are you able to attend study appointments as required?
Are you willing to complete questionnaires about your pain and quality of life?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the Botulinum Toxin A injection. Before and after the injection, the research team would ask you to complete some questionnaires to understand your pain levels (using a scale called VAS) and how well you manage your bowel movements (using a scale called Wesner). If you have problems with bowel control, you would also complete a questionnaire about your quality of life (called FIQL). Additionally, an ultrasound scan would be performed to measure a specific muscle in your back passage. The total duration of your involvement in the study would depend on how long they need to follow up on your progress after the injection.

Potential risks and benefits

Taking part in this study could potentially help reduce your pain from chronic anal fissures and improve your quality of life. However, like any medical treatment, there might be some risks or side effects from the injection, such as temporary weakness in the area or discomfort. The research team will explain all known potential risks to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is an anal fissure?

An anal fissure is a small tear in the lining of the back passage, which can cause pain and bleeding, especially during bowel movements. 'Chronic' means it's been there for a long time.

What is Botulinum Toxin A?

It's a medicine, often called Botox, that can relax muscles. In this study, it's used to relax the muscle around the back passage, which can help a fissure heal.

Will the injection hurt?

The team will do their best to make you comfortable. It's an injection, so you might feel a brief sting or discomfort, but local anaesthetic might be used.

How long will I be involved in the study?

The study team will let you know the exact follow-up schedule and total duration of your participation, which depends on how long they need to monitor the treatment's effects.

Do I have to take part?

No, taking part is completely your choice. Your decision won't affect the care you receive from your doctor now or in the future.