Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID05998187

Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections in Patients With Fecal Incontinence

Led by University Hospital, Rouen · Updated on 2026-01-22

21

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how intra-rectal botulinum toxin injections work in patients with fecal incontinence, a condition affecting about 5 to 6% of the population that severely impacts quality of life. This treatment is being studied because current options are limited and not always effective. The study aims to better understand the toxin's effect on rectal muscle movements to identify which patients might benefit the most. The study involves patients who have fecal incontinence that has not improved with standard treatments. Participants will receive intra-rectal injections of botulinum toxin. Researchers will use a high-resolution recto-sigmoid manometry probe to measure rectal and sigmoid colon muscle activity before and one month after the injections. This method will assess how the injections affect rectal contractions both naturally and after a stimulant laxative. Participants will undergo assessments including measurements of muscle contractions, probe expulsion, severity of anal incontinence, quality of life, and monitoring for any adverse events over four months. These evaluations occur before and one month after treatment to gauge changes. The study will last several months, with careful monitoring to ensure participant safety and collect detailed information on how the treatment influences rectal motility and symptoms.

CONDITIONS

Brief Title

Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active or predominantly active fecal incontinence with failure of first-line conservative treatments such as transit regulation and perineal re-education
  • Impaired quality of life as determined by the investigator
  • At least 18 years of age
  • Ability to read, understand information, and sign consent form
  • Affiliation with the French Social Security system
  • Women of childbearing age must use effective contraception for at least 1 month and have a negative pregnancy test at inclusion and during the study
  • Postmenopausal women must have confirmed diagnosis of non-medically induced amenorrhea for at least 12 months prior to inclusion
Not Eligible

You will not qualify if you...

  • Pregnant, laboring, breastfeeding women, or women without proven contraception
  • Individuals deprived of liberty by judicial or administrative decision, or protected adults under guardianship
  • Exclusive passive fecal incontinence
  • Constipation according to Rome IV criteria
  • Active inflammatory or cancerous digestive diseases
  • Previous rectal surgery
  • Participation in another research protocol within 4 weeks before inclusion
  • Allergy or hypersensitivity to botulinum toxin or its ingredients
  • Neuromuscular junction diseases such as myasthenia or Lambert-Eaton syndrome
  • Infection at injection sites
  • General anesthesia less than one month before study
  • Use of aminoglycosides or anti-cholinesterase agents
  • History of neurogenic damage or swallowing disorders
  • Botulinum toxin injections within 3 months before study
  • Clinical anal examination suggesting anorectal abscess
  • Recent (less than 12 months) myocardial infarction or rhythm disorders not controlled by treatment
  • Severe neurological disorders or peripheral motor neuropathies
  • Current anticoagulant or anti-aggregant therapy with major thrombo-embolic risk
  • Local pathology preventing colonoscopy such as anal stenosis
  • Allergy to silicone or latex
  • Contraindication to specified laxatives used in study
  • Clinically diagnosed intestinal obstruction
  • Severe coagulopathy or oral anticoagulants
  • Cardiac disorders poorly tolerated with vagal stimulation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 month

Participants receive intra-rectal botulinum toxin injections to treat fecal incontinence after failure of conservative treatments.

1 baseline visit and 1 follow-up visit

Follow-up

Duration - 4 months

Participants are monitored for adverse events and treatment effects for up to 4 months after injections.

Visits at each follow-up during 4 months

Trial Site Locations

Total: 1 location

1

Univesity Hospital, Rouen

Rouen, France, France, 76031

Actively Recruiting

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Research Team

C

Charlotte DESPREZ

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

Charlotte Desprez, Henri Damon, Guillaume Meurette...

https://pubmed.ncbi.nlm.nih.gov/32740249