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New treatment option for Fecal Incontinence
Official title Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections
ClinicalTrials.gov ID: NCT05998187
What this study is testing
What is intra-rectal botulinum toxin injections?
intra-rectal botulinum toxin injections is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for fecal incontinence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
You likely can't join if
- General
- Pregnant women, women in labor, breastfeeding women, or women without proven contraception
- 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
See the full eligibility criteria
- 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...
- Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to inclusion visit)
- General
- Pregnant women, women in labor, breastfeeding women, or women without proven contraception
- 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 Linked to botulinum toxin injections
- Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium chloride)
- Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.)
- 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). When patients are on anticoagulant or anti-aggregant therapy, the type of injections to be performed...
- 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...
- Local pathology preventing colonoscopy (anal stenosis)
- Allergy or hypersensitivity to silicone and/or latex Linked to laxatives
- Contraindication to DULCOLAX® 5 mg, gastro-resistant coated tablet
- Contraindication to XIMEPEG®, powder for oral solution Linked to high-resolution manometry
- Clinically diagnosed intestinal obstruction
- Severe coagulopathy or oral anticoagulants
- Cardiac disorders for which vagal stimulation is poorly tolerated
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.