Patients with fecal incontinence who have failed conservative treatments and are candidates for intrarectal botulinum toxin injections. MedDRA version: 20.0 Level: LLT Classification code 10016296 Term: Fecal incontinence System Organ Class: 100000004856
Conditions
Interventions
Trade Name: BOTOX 200 UNITÉS ALLERGAN, poudre pour solution injectable
Product Name: BOTOX 200 UNITÉS ALLERGAN, poudre pour solution injectable
Pharmaceutical Form: Powder for injection
Sponsors
CHU de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Active or predominantly active fecal incontinence with failure of first-line conservative treatments (normalization of transit, perineal rehabilitation) - Impairment of quality of life left to the discretion of the investigator - Patients at least 18 years old - 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 with effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) and a negative urine pregnancy test by -HCG at inclusion, during the study period. - Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) - Men with a partner of childbearing age who must take contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) at inclusion, for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - Pregnant woman, parturient, breastfeeding woman, woman able to procreate who has not had effective contraception according to the WHO definition (oestro-progestin or intra-uterine device or tubal ligation) for at least 3 months - Patient deprived of liberty by an administrative or judicial decision or subject of legal age (under guardianship or curatorship) - Exclusive passive fecal incontinence - Person suffering from constipation (Rome IV criteria) -Person presenting an inflammatory or cancerous digestive pathology - History of rectal surgery - Person participating in another research protocol or having participated in another research protocol within 4 weeks prior to the inclusion visit - Patients unable to receive botulinum toxin injections - patients who cannot tolerate short colonoscopy or manometry recording - patients with contraindications to colonic purging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: 1 month after BOTOX injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints were: - 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). - 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. - 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. - Adverse events, which will be collected at each visit - Tolerance of the botulinum toxin treatment ;Timepoint(s) of evaluation of this end point: 1 month after botulinum toxin injections. | — |
Countries
France
Contacts
Public ContactDavid Mallet
CHU de Rouen
Outcome results
None listed