Effect and Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence
NCT ID: NCT02414425
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2015-12-31
2019-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rectal Injection of Botulinum toxin A
Botulinum toxin A will be injected during rectoscopy for patient with rectal incontinence.
Anorectal manometry will be performed for evaluation of efficacy of experimental drug
Rectoscopy
A rectoscopy will be performed for Botulinum toxin A or physiologic serum injection
Anorectal manometry
Anorectal manometry will be performed to evaluate efficacy of Botulinum toxin A or physiologic serum rectal injection
Botulinum toxin A or physiologic serum injection
Botulinum toxin A or physiologic serum injection is performed during rectoscopy
Rectal Injection of physiologic serum
physiologic serum will be injected during rectoscopy for patient with rectal incontinence.
Anorectal manometry will be performed for evaluation of efficacy of placebo
Rectoscopy
A rectoscopy will be performed for Botulinum toxin A or physiologic serum injection
Anorectal manometry
Anorectal manometry will be performed to evaluate efficacy of Botulinum toxin A or physiologic serum rectal injection
Botulinum toxin A or physiologic serum injection
Botulinum toxin A or physiologic serum injection is performed during rectoscopy
Interventions
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Rectoscopy
A rectoscopy will be performed for Botulinum toxin A or physiologic serum injection
Anorectal manometry
Anorectal manometry will be performed to evaluate efficacy of Botulinum toxin A or physiologic serum rectal injection
Botulinum toxin A or physiologic serum injection
Botulinum toxin A or physiologic serum injection is performed during rectoscopy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Anne-Marie LEROI, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Franck ZERBIB, Pr
Role: primary
Michel QUERALTO, MD
Role: primary
François MION, Pr
Role: primary
Véronique VITTON, MD
Role: primary
Gérard AMARENCO, Pr
Role: primary
Isabelle ETIENNEY, MD
Role: primary
Laurent SIPROUDHIS, Pr
Role: primary
Anne-Marie LEROI, Pr
Role: primary
References
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Leroi AM, Queralto M, Zerbib F, Siproudhis L, Vitton V, Amarenco G, Etienney I, Mion F, Bridoux V, Philip J, Brochard C, Damon H, Lacroix E, Gillibert A, Gourcerol G. Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):147-158. doi: 10.1016/S2468-1253(23)00332-1. Epub 2023 Dec 18.
Other Identifiers
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2014-003650-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2014/008/HP
Identifier Type: -
Identifier Source: org_study_id