AuthorisedTherapeutic exploratory (Phase II)Interventional

Colonic Intramural Injections of Botulin toxin versus placebo to treat fragmented defecation and urgency after restorative total mesorectal excision (TME) for rectal cancer

This study is for people who have had surgery for rectal cancer and are experiencing problems with their bowel movements, such as needing to go frequently or having difficulty emptying their bowel completely. Researchers are investigating if a specific injection, containing a substance similar to Botox, can help improve these symptoms. The study compares this injection to a placebo, which is a dummy treatment without any active medicine, to see if the injection genuinely makes a positive difference. The main goal is to check how patients' bowel symptoms change after three months. If successful, this could offer a new way to help improve quality of life for those affected.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

UZ Leuven

Enrolment target

Start

02 Apr 2026

Rectal Cancer

What is this study about?

This study is exploring a new way to help people who have had surgery for rectal cancer. After this type of surgery, some people experience difficulties with their bowel movements. They might feel a sudden strong urge to go to the toilet, or have difficulty emptying their bowels fully, which can be upsetting and impact their daily life.

The research is testing an intervention where a substance similar to Botox is injected into the wall of the colon. This treatment is being compared with a 'placebo', which is a dummy injection that looks exactly the same but doesn't contain any active medicine. This comparison helps researchers understand if any improvements are genuinely due to the treatment, or if they happen for other reasons.

The main aim is to see if the Botox-like injection helps improve bowel symptoms after three months. Researchers will also be looking at how people feel overall, their quality of life, and any side effects. This study is an important step to find better ways to help people recover and live comfortably after rectal cancer surgery.

Key takeaways

Tests a Botox-like injection for bowel problems after rectal cancer surgery.
Compares the injection to a dummy treatment (placebo).
Aims to improve sudden urges and difficulty emptying bowels.
Involves regular check-ups and questionnaires over six months.
Could offer a new way to improve quality of life for survivors.

Who may be eligible?

This study is open to adults aged 18 and over, of any gender. People who might be a good fit for this study have already had surgery for rectal cancer. The surgery specifically mentioned is a 'total mesorectal excision' (TME), which is a common operation for rectal cancer.

To be considered, you would need to be experiencing specific problems with your bowel movements following this surgery, such as needing to go urgently or feeling like you can't empty your bowels completely. Doctors and nurses involved in the study would check your medical history and current health to make sure the study is right for you and safe.

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 had surgery for rectal cancer, specifically a TME operation?
Are you experiencing problems with bowel control, like urgency or incomplete emptying?
Are you open to receiving either an active treatment or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the active injection or a placebo injection. You wouldn't know which one you received, nor would your doctors, to keep the study fair. Throughout the study, you would have several appointments with the research team. These appointments would involve clinical checks, where doctors assess your health, and you would also be asked to fill out questionnaires about your symptoms and how you are feeling. These questionnaires help measure changes in your bowel habits and overall quality of life.

Appointments would typically take place one month, three months, and six months after the treatment. Researchers would also monitor for any side effects. The total duration of your active participation in looking at how the treatment works would be for six months.

Potential risks and benefits

Participating in this study might offer a potential benefit if you receive the active treatment and it helps improve your bowel problems, potentially leading to a better quality of life. Even if you receive the placebo, you will be closely monitored, and your health will be assessed regularly. However, as with any medical procedure, there are potential risks, such as discomfort or side effects from the injections, though these would be carefully explained. You have the full right to withdraw from the study at any time, for any reason, without it affecting your 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
Belgium

Common questions

What is Botox, and why is it used here?

Botox, or more accurately a substance similar to it called botulinum toxin, is being used here because it can temporarily relax muscles. Researchers think relaxing certain muscles in your bowel might help with problems like urgency or incomplete emptying after surgery.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medication but contains no active ingredients. It's used to fairly compare the effects of the actual treatment against just the idea of receiving treatment.

Will I know if I get the real injection or the placebo?

No, neither you nor your doctors will know whether you received the active injection or the placebo. This is called 'blinding' and helps ensure the study results are as accurate as possible.

How long will I be involved in the study?

After your injection, you will be followed up for about six months with regular check-ups to see how you are doing and how your symptoms progress.

What is 'fragmented defecation and urgency'?

These are terms for problems like needing to go to the toilet very suddenly and often, or feeling like you haven't completely emptied your bowels, even after trying. They can be common after rectal cancer surgery.