NCT05998187

Brief Summary

Previous studies have demonstrated the efficacy of this treatment in certain patients suffering from fecal incontinence, but it is not yet reimbursed in this indication as it is still in the evaluation phase. Indeed, little is known about botulinum toxin mechanisms of action. The aim of this study is to better understand the mechanisms of action of intra-rectal botulinum toxin injections, so that the investigators can identify the patients most likely to benefit from this treatment in the future.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
19mo left

Started Apr 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

August 2, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

August 2, 2023

Last Update Submit

January 20, 2026

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • high amplitude propagative contractions

    The primary endpoint is the time to onset of high amplitude propagative contractions (HAPC) after instillation of DULCOLAX® in the sigmoid and rectum, before and 1 month after intrarectal botulinum toxin injections.

    before and 1 month after intrarectal botulinum toxin injections.

Secondary Outcomes (5)

  • Characteristics of contractions in the rectum and sigmoid

    before and 1 month after intrarectal botulinum toxin injections.

  • Probe expulsion

    before and 1 month after intrarectal botulinum toxin injections.

  • Anal incontinence severity score

    before and 1 month after botulinum toxin injections.

  • Quality of life score

    before and 1 month after botulinum toxin injections.

  • Adverse events

    at each visit, during 4 months

Study Arms (1)

intra-rectal botulinum toxin injections

EXPERIMENTAL

Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.

Drug: intra-rectal botulinum toxin injections

Interventions

intra-rectal botulinum toxin injectionsDRUG

Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.

intra-rectal botulinum toxin injections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active or predominantly active fecal incontinence with failure of 1st-line conservative treatments (normalization of transit, perineal re-education)
  • Impairment of quality of life at investigator's discretion
  • Patients at least 18 years of age
  • Patients who have read and understood the information letter and signed the consent form
  • Patients affiliated to the French Social Security system

You may not qualify if:

  • General
  • Pregnant women, women in labor, breastfeeding women, or women without proven contraception
  • Patient deprived of liberty by administrative or judicial decision, or protected adult (under guardianship or trusteeship)
  • Exclusive passive fecal incontinence
  • Patient suffering from constipation (Rome IV criteria)
  • Patient with an evolving inflammatory or cancerous digestive pathology
  • Previous rectal surgery
  • Linked to botulinum toxin injections
  • Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium chloride)
  • Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.)
  • Presence of infection at injection site(s)
  • General anesthesia less than one month ago
  • Association with aminoglycosides and anti-cholinesterase agents (risk of increased toxin effects)
  • History of neurogenic damage such as polyradiculoneuritis
  • History of dysphagia with esophageal or neurological stasis, swallowing disorders, inhalation pneumonitis
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesity Hospital, Rouen

Rouen, France, 76031, France

RECRUITING

Related Publications (5)

  • Rao SS, Bharucha AE, Chiarioni G, Felt-Bersma R, Knowles C, Malcolm A, Wald A. Functional Anorectal Disorders. Gastroenterology. 2016 Mar 25:S0016-5085(16)00175-X 10.1053/j.gastro.2016.02.009. doi: 10.1053/j.gastro.2016.02.009. Online ahead of print.

    PMID: 27144630BACKGROUND

  • Xu X, Menees SB, Zochowski MK, Fenner DE. Economic cost of fecal incontinence. Dis Colon Rectum. 2012 May;55(5):586-98. doi: 10.1097/DCR.0b013e31823dfd6d.

    PMID: 22513438BACKGROUND

  • Desprez C, Damon H, Meurette G, Mege D, Faucheron JL, Brochard C, Lambrescak E, Gourcerol G, Mion F, Wyart V, Sielezneff I, Siproudhis L, Etienney I, Ajamie N, Lehur PA, Duflot T, Bridoux V, Leroi AM; Club NEMO. Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study. Ann Surg. 2022 Apr 1;275(4):735-742. doi: 10.1097/SLA.0000000000004251.

    PMID: 32740249BACKGROUND

  • Bridoux V, Gourcerol G, Kianifard B, Touchais JY, Ducrotte P, Leroi AM, Michot F, Tuech JJ. Botulinum A toxin as a treatment for overactive rectum with associated faecal incontinence. Colorectal Dis. 2012 Mar;14(3):342-8. doi: 10.1111/j.1463-1318.2011.02585.x.

    PMID: 21689287BACKGROUND

  • Gourcerol G, Benard C, Melchior C, Touchais JY, Ducrotte P, Menard JF, Bridoux V, Leroi AM. Botulinum toxin: an endoscopic approach for treating fecal incontinence. Endoscopy. 2016 May;48(5):484-8. doi: 10.1055/s-0034-1393242. Epub 2015 Oct 8.

    PMID: 26448532BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Charlotte DESPREZ

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte DESPREZ

CONTACT

0232888039charlotte.desprez@chu-rouen.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 18, 2023

Study Start

April 15, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)