Study on the Effects of Botulinum Toxin Type A and a Drug Combination on Rectal Function in Patients with Fecal Incontinence

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for fecal incontinence, a condition where individuals have difficulty controlling their bowel movements. The treatment being investigated involves injections of botulinum toxin type A, commonly known as Botox, directly into the rectum. The purpose of the study is to understand how these injections affect the movement and function of the rectum, particularly when stimulated by laxatives.

Participants in the study will receive the botulinum toxin injections and will be monitored over a period of one month. During this time, researchers will observe changes in rectal movement using a technique called high-resolution manometry, which measures pressure inside the rectum. The study will also involve the use of laxatives such as MOVIPREP and DULCOLAX to stimulate bowel movements and assess the treatment’s impact on rectal motility.

Throughout the study, various aspects will be evaluated, including the number and strength of contractions in the rectum, the time it takes for these contractions to occur, and any changes in the participants’ quality of life. The study will also monitor any side effects that may arise from the treatment. The goal is to gather valuable information that could lead to improved treatments for individuals suffering from fecal incontinence.

1 initial visit and consent

Upon joining the study, the patient will attend an initial visit where the study details are explained. The patient must read and understand the information letter and sign the consent form to participate.

Eligibility is confirmed based on criteria such as age, medical condition, and use of effective contraception for women of childbearing age.

2 baseline assessment

The patient undergoes a baseline assessment to evaluate the severity of fecal incontinence and quality of life using specific scores.

Measurements of rectal motility are taken using high-resolution manometry to establish a baseline before any treatment is administered.

3 botulinum toxin injection

The patient receives an intra-rectal injection of botulinum toxin type A to study its effects on rectal motility.

This step is crucial for assessing the primary objective of the study, which is to observe changes in rectal motility one month after the injection.

4 laxative administration

The patient is administered MOVIPREP, an oral solution containing ascorbic acid and other components, to stimulate rectal motility.

Additionally, DULCOLAX, a gastro-resistant tablet containing bisacodyl, is given to further stimulate rectal contractions.

5 follow-up assessments

One month after the botulinum toxin injection, the patient returns for follow-up assessments.

The study measures the time to onset of high amplitude propagative contractions and other characteristics of rectal contractions.

Quality of life and severity scores are reassessed to determine any changes since the baseline assessment.

6 adverse event monitoring

Throughout the study, any adverse events experienced by the patient are recorded at each visit.

This monitoring ensures patient safety and helps evaluate the overall impact of the treatment.

Who Can Join the Study?

Patients must have active or mostly active fecal incontinence that has not improved with first-line treatments like diet changes or exercises to strengthen the pelvic area.
There must be a noticeable impact on the patient’s quality of life, as determined by the study doctor.
Patients must be at least 18 years old.
Patients must have read and understood the information letter about the study and signed the consent form to participate.
Patients must be affiliated with the French Social Security system.
Women who can have children must use effective birth control methods, such as birth control pills, an intrauterine device (IUD), or have had a tubal ligation, for at least one month before and during the study. They must also have a negative pregnancy test at the start and throughout the study.
Postmenopausal women must have a confirmed diagnosis of menopause, meaning they have not had a period for at least 12 months without medical reasons before joining the study.

Who Cannot Join the Study?

Patients who have a known allergy to botulinum toxin. This is a substance used in the study, and an allergy means the body reacts badly to it.
Patients with a history of neuromuscular disorders. These are conditions that affect the nerves and muscles, making it hard for them to work together.
Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Patients who have had recent surgery on the rectum. The rectum is the last part of the large intestine, where stool is stored before leaving the body.
Patients with severe constipation. Constipation means having difficulty in passing stool, and severe means it’s very serious.
Patients who are unable to follow the study procedures. This means they might not be able to do what is needed for the study.
Patients with active infections. An infection is when germs like bacteria or viruses make the body sick, and active means it’s currently happening.
Patients who are participating in another clinical trial. This is to avoid any interference with the results of the study.

Where you can join this trial?

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Site Name	City	Country	Status
Centre Hospitalier Universitaire Rouen	Rouen	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.11.2024

Trial locations

Investigated drugs:

Botulinum Toxin is used in this trial to understand its effects on rectal motility in patients with fecal incontinence. The medication is administered through injections into the rectum. The study aims to observe how botulinum toxin affects the movement of the rectum when stimulated by a laxative, using a technique called high-resolution manometry to record the results.

Fecal incontinence – Fecal incontinence is the inability to control bowel movements, leading to unexpected leakage of stool. It can occur due to various reasons, including muscle or nerve damage, which affects the ability to hold stool in the rectum. The condition may be associated with a sudden urge to defecate or may occur without any warning. It can vary in severity, from occasional leakage of stool while passing gas to a complete loss of bowel control. Factors such as age, childbirth, and certain medical conditions can increase the risk of developing fecal incontinence. The condition can significantly impact a person’s quality of life, leading to social embarrassment and emotional distress.

Trial ID:

2024-515256-21-00

Protocol code:

2021/0384/HP

NCT ID:

NCT05998187

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Botulinum Toxin Type A and a Drug Combination on Rectal Function in Patients with Fecal Incontinence

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?