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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

8 criteria

  • 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.
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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.

What is already known about the treatment

Botulinum Toxin – This medication is administered through intrarectal injections. It is currently being studied in clinical trials for its effects on rectal motility in patients with fecal incontinence. The main therapeutic indication is to improve bowel control in individuals experiencing fecal incontinence. At the molecular level, botulinum toxin works by blocking the release of neurotransmitters, which reduces muscle contractions. It is classified pharmacologically as a neurotoxin.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515256-21-00Protocol code2021/0384/HPEstimated enrolment21 patientsSponsorCentre Hospitalier Universitaire Rouen

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).