Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections

Recruiting Phase 3 Interventional Study
Fecal Incontinence
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
21 (estimated)
Sponsor
University Hospital, Rouen · Other
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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 …
Trial Locations
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Eligibility Criteria
Inclusion 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 un…
Contacts

Charlotte DESPREZ

0232888039

charlotte.desprez@chu-rouen.fr

CONTACT