Mechanisms of action on rectal motility of intrarectal botulinum toxin injections in patients with fecal incontinence - MECA-TOX
- Conditions
- Fecal incontinenceMedDRA version: 20.0Level: LLTClassification code: 10016296Term: Fecal incontinence Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2024-515256-21-00
- Lead Sponsor
- Centre Hospitalier Universitaire Rouen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
Active or predominantly active fecal incontinence with failure of 1st-line conservative treatments (normalization of transit, perineal re-education), Impairment of quality of life at investigator's discretion, Patients at least 18 years of age, Patients who have read and understood the information letter and signed the consent form, Patients affiliated to the French Social Security system, Women of childbearing age using effective contraception (Cf. CTFG) (estro- progestins or intrauterine device or tubal ligation) for at least 1 month and a negative B-HCG urine pregnancy test at inclusion and for the duration of the study., Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to inclusion visit)
Pregnant women, women in labor, breastfeeding women, or women without proven contraception, Presence of infection at injection site(s), General anesthesia less than one month ago, Association with aminoglycosides and anti-cholinesterase agents (risk of increased toxin effects), History of neurogenic damage such as polyradiculoneuritis, History of dysphagia with esophageal or neurological stasis, swallowing disorders, inhalation pneumonitis, Botulinum toxin injections in the 3 months preceding the study, Clinical anal examination suggestive of anorectal abscess, Recent history (<12 months) of myocardial infarction and/or rhythm disorders not reduced by appropriate treatment, Peripheral motor neuropathies (such as amyotrophic lateral sclerosis or motor neuropathy) and underlying neurological disorders, Current treatment with anticoagulants or anti-aggregants or haemostasis disorders according to recommendations (SFED (Société Française d'endoscopie Digestive)). When patients are on anticoagulant or anti-aggregant therapy, the type of injections to be performed depends on the type of anticoagulation and the patient's thrombo-embolic risk: - Patients on anticoagulant or anti-aggregant therapy with a major thrombo-embolic risk will not be included. - Patients on anticoagulant or anti-aggregant therapy with a moderate or low thrombo-embolic risk may be included. If patients are taking a vitamin K antagonist, treatment will be continued provided that the INR is within the usual range of 2 to 3 (GETED, HAS, 2008). If patients are taking anti-aggregants, these can be continued (SFED, HAS, 2012). If patients are taking new oral anticoagulants, they should take a short break and not take the AOD the evening before or the morning of the injections (GIHP, 2015)., Patient deprived of liberty by administrative or judicial decision, or protected adult (under guardianship or trusteeship), Exclusive passive fecal incontinence, Patient suffering from constipation (Rome IV criteria), Patient with an evolving inflammatory or cancerous digestive pathology, Previous rectal surgery, Person participating in another research protocol or having participated in another research protocol in the 4 weeks preceding the inclusion visit, Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium chloride), Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study, 1 month after intra-rectal injections, the effect of botulinum toxin on rectal motricity stimulated by laxative instillation and recorded in high resolution manometry;Secondary Objective: Evaluate the clinical efficacy of botulinum toxin injections at 1 month after injections, Evaluate the quality of life at 1 month after the injections, Evaluate the tolerance of botulinum toxin injections;Primary end point(s): The primary endpoint was the time to onset of high amplitude propagative contractions (HAPC) after instillation of DULCOLAX® in the sigmoid and rectum, before and 1 month after intra-rectal botulinum toxin injections.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):The characteristics of the contractions at the level of the rectum and the sigmoid measured before then 1 month after injections of botulinum toxin: number, frequency, amplitude, duration of the HAPC, index of contractility, number and characteristics of the contractions (propagated or retropropagated).;Secondary end point(s):Expulsion or not of the probe (which is an indirect sign of the efficiency of the colorectal motricity) as well as the delay of expulsion of the probe.;Secondary end point(s):Severity scores (Cleveland Score, Appendix 2), stool schedule and quality of life score (FIQL Score, Appendix 4) before and 1 month after botulinum toxin injections.;Secondary end point(s):Adverse events, which will be collected at each visit;Secondary end point(s):Tolerance of the botulinum toxin treatment