Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections
ConditionFecal Incontinence
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen
About this trial
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. The aim of this study is to better understand the mechanisms of action of intra-rectal botulinum toxin injections, so that the investigators can identify the patients most likely to benefit from this treatment in the future.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- intra-rectal botulinum toxin injections
Treatment groups
21 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov