Effect and Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence
Status:
Unknown status
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Rouen
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA