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Mechanisms of action on rectal motility of intrarectal botulinum toxin injections in patients with fecal incontinence - MECA-TOX
EU CTIS ID: 2024-515256-21-00
What this study is testing
To study, 1 month after intra-rectal injections, the effect of botulinum toxin on rectal motricity stimulated by laxative instillation and recorded in high colic resolution manometry
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (defined by CTCG guidelines as fertile, after menarche and up to menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy) : using effective contraception according to CTCG guidelines (progestin-only hormonal contraception for which ovulation inhibition is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) for at least 1 month prior to inclusion and for the duration of the study And, with a negative urine pregnancy test by -HCG at inclusion and for the duration of the study.
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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 (defined by CTCG guidelines as fertile, after menarche and up to menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy) : using effective contraception according to CTCG guidelines (progestin-only hormonal contraception for which ovulation inhibition is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) for at least 1 month prior to inclusion and for the duration of the study And, with a negative urine pregnancy test by -HCG at inclusion and for the duration of the study.
- Women: menopausal: menopause according to CTCG guidelines is defined as the absence of menses for 12 months without any other medical cause. An elevated level of follicle-stimulating hormone (FSH) in the post-menopausal interval in women not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months' amenorrhea, a single FSH measurement is insufficient.
What rules you out
- 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.)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.