BISACODYL for Fecal incontinence

Inclusion criteria

• {"criterion_text":"- Active or predominantly active fecal incontinence with failure of 1st-line conservative treatments (normalization of transit, perineal re-education)\n- Impairment of quality of life at investigator's discretion\n- Patients at least 18 years of age\n- Patients who have read and understood the information letter and signed the consent form\n- Patients affiliated to the French Social Security system\n- 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 β-HCG at inclusion and for the duration of the study.\n- 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."}

Exclusion criteria

• {"criterion_text":"- Pregnant women, women in labor, breastfeeding women, or women without proven contraception\n- Presence of infection at injection site(s)\n- General anesthesia less than one month ago\n- Association with aminoglycosides and anti-cholinesterase agents (risk of increased toxin effects)\n- History of neurogenic damage such as polyradiculoneuritis\n- History of dysphagia with esophageal or neurological stasis, swallowing disorders, inhalation pneumonitis\n- Botulinum toxin injections in the 3 months preceding the study\n- Clinical anal examination suggestive of anorectal abscess\n- Recent history (<12 months) of myocardial infarction and/or rhythm disorders not reduced by appropriate treatment\n- Peripheral motor neuropathies (such as amyotrophic lateral sclerosis or motor neuropathy) and underlying neurological disorders\n- 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).\n- Patient deprived of liberty by administrative or judicial decision, or protected adult (under guardianship or trusteeship)\n- Exclusive passive fecal incontinence\n- Patient suffering from constipation (Rome IV criteria)\n- Patient with an evolving inflammatory or cancerous digestive pathology\n- Previous rectal surgery\n- Person participating in another research protocol or having participated in another research protocol in the 4 weeks preceding the inclusion visit\n- Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium chloride)\n- Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time to onset of high amplitude propagative contractions (HAPC) after DULCOLAX instillation in sigmoid and rectum measured before and 1 month after intra-rectal botulinum toxin injections; recorded by high-resolution colonic manometry (as stated in objectives)."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Contractility characteristics (number, frequency, amplitude, duration, index of contractility, propagation) measured by high-resolution colonic manometry before and 1 month after injections."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Binary assessment of probe expulsion and time (delay) to expulsion as an indirect measure of colorectal motility."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Clinical scores: Cleveland Score for severity, FIQL for quality of life, and stool diary/schedule recorded before and 1 month after injections."}
• {"endpoint_text":"- Adverse events, which will be collected at each visit","definition_or_measurement_approach":"Collection and recording of adverse events at each study visit."}
• {"endpoint_text":"- The quality of life score (FIQL Score, Appendix 4) before and 1 month after botulinum toxin injections.","definition_or_measurement_approach":"FIQL questionnaire administered before and 1 month after injections to assess quality of life."}

France

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

592

Number Of Sites

1

Number Of Participants

21

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France