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Botox shots for bowel control: a new hope for fecal incontinence?

NCT ID NCT02414425

Symptom relief Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether injecting botulinum toxin (like Botox) into the rectum can reduce episodes of accidental bowel leakage and urgent bathroom needs in people with fecal incontinence. The trial involved 200 adults whose condition did not improve with standard treatments. The goal was to see if these injections could improve quality of life with few side effects, though any benefits are expected to be temporary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

200 people

The number who actually took part.

Started

Nov 2015

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fecal incontinence

Contacts and locations

Locations

  • AP-HM Hôpital Nord

    Marseille, France

  • AP-HP Hôpital Tenon

    Paris, France

  • Bordeaux University Hospital

    Bordeaux, France

  • Clinique des Cèdres

    Cornebarrieu, France

  • Hospices Civils de Lyon

    Lyon, France

  • Hôpital des Diaconesses

    Paris, France

  • Rennes University Hospital

    Rennes, France

  • Rouen University Hospital

    Rouen, 76031, France

More trials for these conditions

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