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Effect And Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence
Fecal incontinence is a frequent pathology which concerns 10% of the general population and severely alters patients quality of life. The cost of urinary and faecal incontinence has been estimated to be $16 billions a year. Several treatments exist depending on the aetiology of the faecal incontinence: medical treatments, biofeedback and sacral nerve stimulation. Nevertheless, these treatments are not always effective (50-70% of success) and are not without side effects, particularly the sacral nerve stimulation (pain, infection, electrode displacement..). The intravesical injections of botulinum toxin have been used for several years for the treatment of urinary incontinence with overactive bladder. Several randomized trials have demonstrated the efficacy of these injections in patients with neurological disorders and overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the detrusor muscle increase the compliance and the bladder capacity and delay the initial appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve afferents. The botulinum toxin should play a role on motor afferents as well as on the sensory function of efferent nerves. The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency episodes with improvement in quality of life, without any major side effects, in the patients included in this study. Nevertheless, the benefit of toxin injections are known to be temporary because of nerve re-growth. If we obtain similar results for fecal incontinence, it would be possible to schedule one to two injections a year because of the limited side-effects and invasiveness of the rectal injections.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Bordeaux University Hospital
Bordeaux, France
Clinique des Cèdres
Cornebarrieu, France
Hospices Civils de Lyon
Lyon, France
AP-HM Hôpital Nord
Marseille, France
AP-HP Hôpital Tenon
Paris, France
Hôpital des Diaconesses
Paris, France
Rennes University Hospital
Rennes, France
Rouen University Hospital
Rouen, France
Start Date
November 25, 2015
Primary Completion Date
March 30, 2022
Completion Date
March 30, 2022
Last Updated
January 22, 2026
200
ACTUAL participants
Rectoscopy
PROCEDURE
Anorectal manometry
PROCEDURE
Botulinum toxin A or physiologic serum injection
DRUG
Lead Sponsor
University Hospital, Rouen
NCT05626816
NCT06532123
NCT03825575
Data Source & Attribution
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