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Fecal IncontinencePhase 3FI_TOXINNCT02414425

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

A Phase 3 study testing Rectoscopy, Anorectal manometry and Botulinum toxin A or physiologic serum injection in people with Fecal Incontinence, run by University Hospital, Rouen at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fecal Incontinence
What is being tested?
Rectoscopy, Anorectal manometry and Botulinum toxin A or physiologic serum injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
8 sitesFrance
Study dates
25 Nov 2015to 30 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 16Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Bordeaux University Hospital

    Bordeaux

  • Clinique des Cèdres

    Cornebarrieu

  • Hospices Civils de Lyon

    Lyon

  • AP-HM Hôpital Nord

    Marseille

  • AP-HP Hôpital Tenon

    Paris

  • Hôpital des Diaconesses

    Paris

  • Rennes University Hospital

    Rennes

  • Rouen University Hospital

    Rouen, 76031

Other trials in France

About this study

Official title: 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.

Read more

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.

Being tested
Rectoscopy, Anorectal manometry, Botulinum toxin A or physiologic serum injection
Keywords
Fecal Incontinence, Botulinum Toxin A, Rectal injection
Medical subject headings
Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RectoscopyProcedure or surgery

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

  • Anorectal manometryProcedure or surgery

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

  • Botulinum toxin A or physiologic serum injectionDrug

    Botulinum toxin A or physiologic serum injection is performed during rectoscopy

Study groups in NCT02414425
Study groupRoleWhat they receive
Rectal Injection of Botulinum toxin AExperimentalBotulinum toxin A will be injected during rectoscopy for patient with rectal incontinence. Anorectal manometry will be performed for evaluation of efficacy of experimental drug
Receives: Procedure: Rectoscopy; Procedure: Anorectal manometry; Drug: Botulinum toxin A or physiologic serum injection
Rectal Injection of physiologic serumPlacebo comparatorphysiologic serum will be injected during rectoscopy for patient with rectal incontinence. Anorectal manometry will be performed for evaluation of efficacy of placebo
Receives: Procedure: Rectoscopy; Procedure: Anorectal manometry; Drug: Botulinum toxin A or physiologic serum injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 Month

  2. Change from baseline in the Number of urgencies episodes per week

    The number of urgencies episodes is evaluated using a bowel diary

    Measured: 1 Month

Secondary outcomes (13)

  1. Number of Adverse Events

    Imputability of Adverse events is evaluated by investigator

    Measured: 6 Months

  2. Number of Adverse Events

    Imputability of Adverse events is evaluated by investigator

    Measured: 1 Month

  3. Number of Adverse Events

    Imputability of Adverse events is evaluated by investigator

    Measured: 3 Months

  4. Change from baseline in the severity of fecal incontinence

    The severity of fecal incontinence is evaluated using Cleveland Clinic Score

    Measured: 6 Months

  5. Change from baseline in the severity of fecal incontinence

    The severity of fecal incontinence is evaluated using Cleveland Clinic Score

    Measured: 3 Months

  6. Change from baseline in the severity of fecal incontinence

    The severity of fecal incontinence is evaluated using Cleveland Clinic Score

    Measured: 1 Month

  7. Change from baseline on delay in postponing defecation

    postponing defecation delay is evaluated using a bowel diary

    Measured: 6 Months

  8. Change from baseline on delay in postponing defecation

    postponing defecation delay is evaluated using a bowel diary

    Measured: 3 Months

  9. Change from baseline on delay in postponing defecation

    postponing defecation delay is evaluated using a bowel diary

    Measured: 1 Month

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

    The number of fecaI incontinence episodes and/or urgencies is evaluated using a bowel diary

    Measured: 6 months

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

    The number of fecaI incontinence episodes and/or urgencies is evaluated using a bowel diary

    Measured: 3 months

  12. Change from baseline in the Number of urgencies episodes per week

    The number of urgencies episodes is evaluated using a bowel diary

    Measured: 6 months

  13. Change from baseline in the Number of urgencies episodes per week

    The number of urgencies episodes is evaluated using a bowel diary

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2015 (estimated)
  2. Study start25 Nov 2015
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414425
Sponsor's protocol ID
2014/008/HP
Other IDs
2014-003650-14, 2014
Acronym
FI_TOXIN
Status last verified
Jan 2026
First submitted
1 Apr 2015
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38128556

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rectoscopy, Anorectal manometry and Botulinum toxin A or physiologic serum injection in people with Fecal Incontinence, run by University Hospital, Rouen at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Number of active fecaI incontinence episodes per week (time frame: 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02414425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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