Effect and Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence

NCT02414425 | Completed Phase 3

• 2 other identifiers: 2014/008/HP2014-003650-14
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Fecal Incontinence

Keywords

Fecal Incontinence; Botulinum Toxin A; Rectal injection

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the Number of active fecaI incontinence episodes per week

  The number of fecaI incontinence episodes is evaluated using a bowel diary

  1 Month

• Change from baseline in the Number of urgencies episodes per week

  The number of urgencies episodes is evaluated using a bowel diary

  1 Month

Secondary Outcomes (13)

• Number of Adverse Events

  6 Months

• Number of Adverse Events

  1 Month

• Number of Adverse Events

  3 Months

• Change from baseline in the severity of fecal incontinence

  6 Months

• Change from baseline in the severity of fecal incontinence

  3 Months

Study Arms (2)

Rectal Injection of Botulinum toxin A

EXPERIMENTAL

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

Procedure: Rectoscopy; Procedure: Anorectal manometry; Drug: Botulinum toxin A or physiologic serum injection

Rectal Injection of physiologic serum

PLACEBO COMPARATOR

physiologic serum will be injected during rectoscopy for patient with rectal incontinence. Anorectal manometry will be performed for evaluation of efficacy of placebo

Procedure: Rectoscopy; Procedure: Anorectal manometry; Drug: Botulinum toxin A or physiologic serum injection

Interventions

Rectoscopy PROCEDURE

A rectoscopy will be performed for Botulinum toxin A or physiologic serum injection

Rectal Injection of Botulinum toxin A; Rectal Injection of physiologic serum

Anorectal manometry PROCEDURE

Anorectal manometry will be performed to evaluate efficacy of Botulinum toxin A or physiologic serum rectal injection

Rectal Injection of Botulinum toxin A; Rectal Injection of physiologic serum

Botulinum toxin A or physiologic serum injection DRUG

Botulinum toxin A or physiologic serum injection is performed during rectoscopy

Rectal Injection of Botulinum toxin A; Rectal Injection of physiologic serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (8)

Bordeaux University Hospital

Bordeaux, France

Location

Clinique des Cèdres

Cornebarrieu, France

Location

Hospices Civils de Lyon

Lyon, France

Location

AP-HM Hôpital Nord

Marseille, France

Location

AP-HP Hôpital Tenon

Paris, France

Location

Hôpital des Diaconesses

Paris, France

Location

Rennes University Hospital

Rennes, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 38128556 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Proctoscopy; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Anne-Marie LEROI, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 10, 2015
• Study Start: November 25, 2015
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

FR (8)