Actively Recruiting
Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections
Led by University Hospital, Rouen · Updated on 2026-01-22
21
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Previous studies have demonstrated the efficacy of this treatment in certain patients suffering from fecal incontinence, but it is not yet reimbursed in this indication as it is still in the evaluation phase. Indeed, little is known about botulinum toxin mechanisms of action. The aim of this study is to better understand the mechanisms of action of intra-rectal botulinum toxin injections, so that the investigators can identify the patients most likely to benefit from this treatment in the future.
CONDITIONS
Official Title
Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active or predominantly active fecal incontinence with failure of first-line conservative treatments (transit normalization, perineal re-education)
- Quality of life impairment as judged by the investigator
- At least 18 years old
- Able to read, understand information letter and sign consent form
- Affiliated with the French Social Security system
- Women of childbearing age using effective contraception for at least 1 month and negative pregnancy test at inclusion and during study
- Postmenopausal women diagnosed with non-medically induced amenorrhea for at least 12 months prior to inclusion
You will not qualify if you...
- Pregnant, in labor, breastfeeding, or women without proven contraception
- Deprived of liberty by administrative or judicial decision, or under guardianship/trusteeship
- Exclusive passive fecal incontinence
- Suffering from constipation as per Rome IV criteria
- Having evolving inflammatory or cancerous digestive disease
- Previous rectal surgery
- Participating or participated in another research protocol within 4 weeks before inclusion
- Hypersensitivity to botulinum toxin or excipients
- Neuromuscular junction disorders (e.g., myasthenia, Lambert-Eaton syndrome)
- Infection at injection site(s)
- General anesthesia within the past month
- Using aminoglycosides or anti-cholinesterase agents
- History of neurogenic damage such as polyradiculoneuritis
- History of dysphagia with esophageal or neurological stasis, swallowing disorders, inhalation pneumonitis
- Botulinum toxin injections within 3 months before study
- Anal examination suggestive of anorectal abscess
- Recent (less than 12 months) myocardial infarction or rhythm disorders not controlled by treatment
- Peripheral motor neuropathies or underlying neurological disorders
- Current anticoagulant or anti-aggregant treatment with high thrombo-embolic risk
- Local pathology preventing colonoscopy (anal stenosis)
- Allergy to silicone or latex
- Contraindication to Dulcolax 5 mg or Ximepeg powder
- Intestinal obstruction
- Severe coagulopathy or oral anticoagulant use
- Cardiac disorders poorly tolerated with vagal stimulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Univesity Hospital, Rouen
Rouen, France, France, 76031
Actively Recruiting
Research Team
C
Charlotte DESPREZ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here