Informations générales (source: ClinicalTrials.gov)
Effect And Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence
Interventional
Phase 3
University Hospital, Rouen (Voir sur ClinicalTrials)
novembre 2015
mars 2022
09 mai 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Bordeaux University Hospital - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Lyon - France | Contact (sur clinicalTrials) | ||||
| Rouen University Hospital - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM Hôpital Nord - Marseille - France | Contact (sur clinicalTrials) | ||||
| Clinique des Cèdres - Cornebarrieu - France | Contact (sur clinicalTrials) | ||||
| Rennes University Hospital - Rennes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- Patients with at least one episode of active Fecal Incontinence and /or urgency per
week;
- Patients with Fecal Incontinence for at least 3 months;
- Patients with Fecal Incontinence refractory to conventional treatment (medical and
biofeedback);
- Patients having read the information letter and signed informed consent;
- Patients with medical insurance.
Exclusion Criteria:
- Patients younger than 18 years old;
- Pregnant or breast-feeding women or women without effective contraception and of age
to procreate;
- Exclusive passive Fecal Incontinence;
- Fecal Incontinence secondary to anorectal malformation, post-surgery, anorectal
organic disease (cancer, inflammatory bowel disease, post-radiotherapy etc.),
constipation, an anal sphincter lesion which could be repaired as a first step, a
rectal prolapse (the inclusion in the study is possible if Fecal Incontinence
persists after rectopexy, a neurological disease with rapid progress ( stable
neurological status is needed for at least 6 months);
- Patients under guardianship.
- Known Hypersensibility to botulinum toxin;
- Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome);
- Anesthesia performed less than 1 month previously;
- Association with antibiotics
- Neurological pathology such as polyradiculoneuropathy;
- Dysphagia, pneumopathy secondary to dysphagia;
- Botulinum toxin injections during the 3 months before the beginning of the study;
- Known Hypersensitivity to albumin;
- History of inhalation pneumopathy.
- Rectoscopy impossible (anal stenosis for example);
- Anti-coagulant or anti-platelet drug or hemostasis disorders.