Fecal IncontinencePhase 3MECA-TOXNCT05998187
Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections
A Phase 3 study testing intra-rectal botulinum toxin injections in people with Fecal Incontinence, run by University Hospital, Rouen at 1 site in France.
Trial 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. 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?
- intra-rectal botulinum toxin injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2025to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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
- Women of childbearing age using effective contraception (Cf. CTFG) (estro- progestins or intrauterine device or tubal ligation) for at least 1 month and a negative B-HCG urine pregnancy test at inclusion and for the duration of the study.
- Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to inclusion visit)
Who cannot join
- 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
Show all 33Show fewer
- Previous rectal surgery
- Person participating in another research protocol or having participated in another research protocol in the 4 weeks preceding the inclusion visit
- 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
- Botulinum toxin injections in the 3 months preceding the study
- Clinical anal examination suggestive of anorectal abscess
- Recent history (<12 months) of myocardial infarction and/or rhythm disorders not reduced by appropriate treatment
- Peripheral motor neuropathies (such as amyotrophic lateral sclerosis or motor neuropathy) and underlying neurological disorders
- Current treatment with anticoagulants or anti-aggregants or haemostasis disorders according to recommendations (SFED). When patients are on anticoagulant or anti-aggregant therapy, the type of injections to be performed depends on the type of anticoagulation and the patient's thrombo-embolic risk:
- Patients on anticoagulant or anti-aggregant therapy with a major thrombo-embolic risk will not be included.
- Patients on anticoagulant or anti-aggregant therapy with a moderate or low thrombo-embolic risk may be included. If patients are taking a vitamin K antagonist, treatment will be continued provided that the INR is within the usual range of 2 to 3 (GETED, HAS, 2008). If patients are taking anti-aggregants, these can be continued (SFED, HAS, 2012). If patients are taking new oral anticoagulants, they should take a short break and not take the AOD the evening before or the morning of the injections (GIHP, 2015).
- Linked to rectosigmoidoscopy
- Local pathology preventing colonoscopy (anal stenosis)
- Allergy or hypersensitivity to silicone and/or latex
- Linked to laxatives
- Contraindication to DULCOLAX® 5 mg, gastro-resistant coated tablet
- Contraindication to XIMEPEG®, powder for oral solution
- Linked to high-resolution manometry
- Clinically diagnosed intestinal obstruction
- Severe coagulopathy or oral anticoagulants
- Cardiac disorders for which vagal stimulation is poorly tolerated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Univesity Hospital, Rouen
Rouen, France, 76031
Florian VALLIN, 0232886697, florian.vallin@chu-rouen.fr
David MALLET, 0232888265, secretariat.drc@chu-rouen.fr
About this study
Official title: Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections in Patients With Fecal Incontinence
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.
Read the detailed description
Fecal incontinence is a common condition, affecting around 5 to 6% of general population. Although not a serious condition, it severely impairs quality of life and leads to social isolation. Fecal incontinence also has a significant medico-economic cost. When first-line medical treatments fail (transit-regulating therapies, perineal re-education), fecal incontinence patients can be offered treatment with sacral nerve neuromodulation. However, this therapy will only be effective in the long term, and in terms of intention to treat, in less than half of patients who have had the device definitively implanted. Today, no other treatments are available apart from sphincter repair, for which the indications are very limited, or colostomy.
The investigator's team has therefore developed another therapeutic option, intra-rectal injections of botulinum toxin, in patients suffering from active fecal incontinence (i.e., preceded by defecatory urgency). The investigator have conducted two pilot studies, which demonstrated the efficacy of this treatment in an open-label setting, and the investigator are currently completing a randomized, double-blind, controlled study to confirm its efficacy (PHRCN 2014-003650-14). Nevertheless, the mechanisms of action of intra-rectal botulinum toxin injections remain hypothetical. By analogy with the intra-detrusor injections used for over 20 years to treat overactive bladder disease, it is possible that the toxin plays an inhibitory role on rectal motricity. Botulinum toxin inhibits the release of acetylcholine at the neuromuscular junction. Without this release, smooth muscle contraction cannot take place. In one of the two pilot, intra-rectal injections of botulinum toxin were performed in 6 patients with fecal incontinence and hyperactivity of the rectum or colonic reservoir after resection. In addition to the clinically demonstrated effect of these injections, there was a significant reduction in the amplitude of rectal contractions after injection. However, there was no correlation between the observed motor effect of botulinum toxin and the efficacy of the injections. Moreover, some patients did not exhibit colonic or rectal hypermotricity and still benefited from the injections. The investigator would like to continue exploring the motor effect of intra-rectal toxin injections on a larger group of patients suffering from faecal incontinence, using a more powerful motor recording system than anorectal manometry.
For this work, we hypothesize that intra-rectal botulinum toxin injections act primarily via a motor effect by inhibiting propagated rectal contractions. To test this hypothesis, a high-resolution recto-sigmoid manometry probe will be used to evaluate rectal and sigmoidal motricity spontaneously and in response to stimulant laxative injection, before and after intra-rectal injection of botulinum toxin. Patients included will be those suffering from faecal incontinence who have failed conservative treatments and are candidates for intra-rectal injections of botulinum toxin.
- Conditions
- Fecal Incontinence
- Being tested
- intra-rectal botulinum toxin injections
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-rectal botulinum toxin injectionsDrug
Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.
| Study group | Role | What they receive |
|---|---|---|
| intra-rectal botulinum toxin injections | Experimental | Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections. Receives: Drug: intra-rectal botulinum toxin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before and 1 month after intrarectal botulinum toxin injections.
Secondary outcomes (5)
Characteristics of contractions in the rectum and sigmoid
Amplitude of contractions in the rectum and sigmoid
Measured: before and 1 month after intrarectal botulinum toxin injections.
Probe expulsion
Probe expulsion (which is an indirect sign of colorectal motricity efficiency) and time to probe expulsion.
Measured: before and 1 month after intrarectal botulinum toxin injections.
Anal incontinence severity score
Anal incontinence severity score (Cleveland Score) and stool schedule before and 1 month after botulinum toxin injections.
Measured: before and 1 month after botulinum toxin injections.
Quality of life score
Quality of life score (FIQL Score, Appendix 4) before and 1 month after botulinum toxin injections.
Measured: before and 1 month after botulinum toxin injections.
Adverse events
Adverse events will be collected at each visits
Measured: at each visit, during 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start15 Apr 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte DESPREZ, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998187
- Sponsor's protocol ID
- 2021/0384/HP
- Acronym
- MECA-TOX
- Status last verified
- Jan 2026
- First submitted
- 2 Aug 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27144630Xu 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.
PubMed 22513438Desprez 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.
PubMed 32740249Bridoux 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.
PubMed 21689287Gourcerol 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.
PubMed 26448532
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections in Patients With Fecal Incontinence
- ClinicalTrials.gov ID
- NCT05998187
- Acronym / sponsor ID
- MECA-TOX / 2021/0384/HP
- Conditions
- Fecal Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fecal incontinence is a common condition, affecting around 5 to 6% of general population. Although not a serious condition, it severely impairs quality of life and leads to social isolation. Fecal incontinence also has a significant medico-economic cost. When first-line medical treatments fail (transit-regulating therapies, perineal re-education), fecal incontinence patients can be offered treatment with sacral nerve neuromodulation. However, this therapy will only be effective in the long term, and in terms of intention to treat, in less than half of patients who have had the device definitively implanted. Today, no other treatments are available apart from sphincter repair, for which the indications are very limited, or colostomy.
The investigator's team has therefore developed another therapeutic option, intra-rectal injections of botulinum toxin, in patients suffering from active fecal incontinence (i.e., preceded by defecatory urgency). The investigator have conducted two pilot studies, which demonstrated the efficacy of this treatment in an open-label setting, and the investigator are currently completing a randomized, double-blind, controlled study to confirm its efficacy (PHRCN 2014-003650-14). Nevertheless, the mechanisms of action of intra-rectal botulinum toxin injections remain hypothetical. By analogy with the intra-detrusor injections used for over 20 years to treat overactive bladder disease, it is possible that the toxin plays an inhibitory role on rectal motricity. Botulinum toxin inhibits the release of acetylcholine at the neuromuscular junction. Without this release, smooth muscle contraction cannot take place. In one of the two pilot, intra-rectal injections of botulinum toxin were performed in 6 patients with fecal incontinence and hyperactivity of the rectum or colonic reservoir after resection. In addition to the clinically demonstrated effect of these injections, there was a significant reduction in the amplitude of rectal contractions after injection. However, there was no correlation between the observed motor effect of botulinum toxin and the efficacy of the injections. Moreover, some patients did not exhibit colonic or rectal hypermotricity and still benefited from the injections. The investigator would like to continue exploring the motor effect of intra-rectal toxin injections on a larger group of patients suffering from faecal incontinence, using a more powerful motor recording system than anorectal manometry.
For this work, we hypothesize that intra-rectal botulinum toxin injections act primarily via a motor effect by inhibiting propagated rectal contractions. To test this hypothesis, a high-resolution recto-sigmoid manometry probe will be used to evaluate rectal and sigmoidal motricity spontaneously and in response to stimulant laxative injection, before and after intra-rectal injection of botulinum toxin. Patients included will be those suffering from faecal incontinence who have failed conservative treatments and are candidates for intra-rectal injections of botulinum toxin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm
| Arm | Type | Receives |
|---|---|---|
| intra-rectal botulinum toxin injections | Experimental | Drug: intra-rectal botulinum toxin injectionsPatients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (33 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-rectal botulinum toxin injectionsPatients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections. | Drug | intra-rectal botulinum toxin injections |
Primary outcome
high amplitude propagative contractions
Time frame: before and 1 month after intrarectal botulinum toxin injections.
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.
5 secondary outcomes
Characteristics of contractions in the rectum and sigmoid
Time frame: before and 1 month after intrarectal botulinum toxin injections.
Probe expulsion
Time frame: before and 1 month after intrarectal botulinum toxin injections.
Anal incontinence severity score
Time frame: before and 1 month after botulinum toxin injections.
Quality of life score
Time frame: before and 1 month after botulinum toxin injections.
Adverse events
Time frame: at each visit, during 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 27144630Rao 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.
- Background: PubMed 22513438Xu 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.
- Background: PubMed 32740249Desprez 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.
- Background: PubMed 21689287Bridoux 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.
- Background: PubMed 26448532Gourcerol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte DESPREZ principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intra-rectal botulinum toxin injections in people with Fecal Incontinence, run by University Hospital, Rouen at 1 site 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 7 inclusion and 33 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: looking for participants now, 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 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte DESPREZ (0232888039, charlotte.desprez@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high amplitude propagative contractions (time frame: before and 1 month after intrarectal botulinum toxin injections.). 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 NCT05998187, which also lists 5 linked publications.
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.