xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998187</url>
    </required_header>
    <id_info>
      <org_study_id>2021/0384/HP</org_study_id>
      <nct_id>NCT05998187</nct_id>
    </id_info>
    <brief_title>Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections</brief_title>
    <acronym>MECA-TOX</acronym>
    <official_title>Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections in Patients With Fecal Incontinence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Rouen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Rouen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Previous studies have demonstrated the efficacy of this treatment in certain patients&#xD;
        suffering from fecal incontinence, but it is not yet reimbursed in this indication as it is&#xD;
        still in the evaluation phase. Indeed, little is known about botulinum toxin mechanisms of&#xD;
        action. The aim of this study is to better understand the mechanisms of action of&#xD;
        intra-rectal botulinum toxin injections, so that the investigators can identify the patients&#xD;
        most likely to benefit from this treatment in the future.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Fecal incontinence is a common condition, affecting around 5 to 6% of general population.&#xD;
        Although not a serious condition, it severely impairs quality of life and leads to social&#xD;
        isolation. Fecal incontinence also has a significant medico-economic cost. When first-line&#xD;
        medical treatments fail (transit-regulating therapies, perineal re-education), fecal&#xD;
        incontinence patients can be offered treatment with sacral nerve neuromodulation. However,&#xD;
        this therapy will only be effective in the long term, and in terms of intention to treat, in&#xD;
        less than half of patients who have had the device definitively implanted. Today, no other&#xD;
        treatments are available apart from sphincter repair, for which the indications are very&#xD;
        limited, or colostomy.&#xD;
  &#xD;
        The investigator's team has therefore developed another therapeutic option, intra-rectal&#xD;
        injections of botulinum toxin, in patients suffering from active fecal incontinence (i.e.,&#xD;
        preceded by defecatory urgency). The investigator have conducted two pilot studies, which&#xD;
        demonstrated the efficacy of this treatment in an open-label setting, and the investigator&#xD;
        are currently completing a randomized, double-blind, controlled study to confirm its efficacy&#xD;
        (PHRCN 2014-003650-14). Nevertheless, the mechanisms of action of intra-rectal botulinum&#xD;
        toxin injections remain hypothetical. By analogy with the intra-detrusor injections used for&#xD;
        over 20 years to treat overactive bladder disease, it is possible that the toxin plays an&#xD;
        inhibitory role on rectal motricity. Botulinum toxin inhibits the release of acetylcholine at&#xD;
        the neuromuscular junction. Without this release, smooth muscle contraction cannot take&#xD;
        place. In one of the two pilot, intra-rectal injections of botulinum toxin were performed in&#xD;
        6 patients with fecal incontinence and hyperactivity of the rectum or colonic reservoir after&#xD;
        resection. In addition to the clinically demonstrated effect of these injections, there was a&#xD;
        significant reduction in the amplitude of rectal contractions after injection. However, there&#xD;
        was no correlation between the observed motor effect of botulinum toxin and the efficacy of&#xD;
        the injections. Moreover, some patients did not exhibit colonic or rectal hypermotricity and&#xD;
        still benefited from the injections. The investigator would like to continue exploring the&#xD;
        motor effect of intra-rectal toxin injections on a larger group of patients suffering from&#xD;
        faecal incontinence, using a more powerful motor recording system than anorectal manometry.&#xD;
  &#xD;
        For this work, we hypothesize that intra-rectal botulinum toxin injections act primarily via&#xD;
        a motor effect by inhibiting propagated rectal contractions. To test this hypothesis, a&#xD;
        high-resolution recto-sigmoid manometry probe will be used to evaluate rectal and sigmoidal&#xD;
        motricity spontaneously and in response to stimulant laxative injection, before and after&#xD;
        intra-rectal injection of botulinum toxin. Patients included will be those suffering from&#xD;
        faecal incontinence who have failed conservative treatments and are candidates for&#xD;
        intra-rectal injections of botulinum toxin.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2027</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single arm</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>high amplitude propagative contractions</measure>
      <time_frame>before and 1 month after intrarectal botulinum toxin injections.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Characteristics of contractions in the rectum and sigmoid</measure>
      <time_frame>before and 1 month after intrarectal botulinum toxin injections.</time_frame>
      <description>Amplitude of contractions in the rectum and sigmoid</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Probe expulsion</measure>
      <time_frame>before and 1 month after intrarectal botulinum toxin injections.</time_frame>
      <description>Probe expulsion (which is an indirect sign of colorectal motricity efficiency) and time to probe expulsion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anal incontinence severity score</measure>
      <time_frame>before and 1 month after botulinum toxin injections.</time_frame>
      <description>Anal incontinence severity score (Cleveland Score) and stool schedule before and 1 month after botulinum toxin injections.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life score</measure>
      <time_frame>before and 1 month after botulinum toxin injections.</time_frame>
      <description>Quality of life score (FIQL Score, Appendix 4) before and 1 month after botulinum toxin injections.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>at each visit, during 4 months</time_frame>
      <description>Adverse events will be collected at each visits</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">21</enrollment>
    <condition>Fecal Incontinence</condition>
    <arm_group>
      <arm_group_label>intra-rectal botulinum toxin injections</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>intra-rectal botulinum toxin injections</intervention_name>
      <description>Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.</description>
      <arm_group_label>intra-rectal botulinum toxin injections</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Active or predominantly active fecal incontinence with failure of 1st-line&#xD;
               conservative treatments (normalization of transit, perineal re-education)&#xD;
  &#xD;
            -  Impairment of quality of life at investigator's discretion&#xD;
  &#xD;
            -  Patients at least 18 years of age&#xD;
  &#xD;
            -  Patients who have read and understood the information letter and signed the consent&#xD;
               form&#xD;
  &#xD;
            -  Patients affiliated to the French Social Security system&#xD;
  &#xD;
            -  Women of childbearing age using effective contraception (Cf. CTFG) (estro- progestins&#xD;
               or intrauterine device or tubal ligation) for at least 1 month and a negative B-HCG&#xD;
               urine pregnancy test at inclusion and for the duration of the study.&#xD;
  &#xD;
            -  Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at&#xD;
               least 12 months prior to inclusion visit)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          General&#xD;
  &#xD;
            -  Pregnant women, women in labor, breastfeeding women, or women without proven&#xD;
               contraception&#xD;
  &#xD;
            -  Patient deprived of liberty by administrative or judicial decision, or protected adult&#xD;
               (under guardianship or trusteeship)&#xD;
  &#xD;
            -  Exclusive passive fecal incontinence&#xD;
  &#xD;
            -  Patient suffering from constipation (Rome IV criteria)&#xD;
  &#xD;
            -  Patient with an evolving inflammatory or cancerous digestive pathology&#xD;
  &#xD;
            -  Previous rectal surgery&#xD;
  &#xD;
            -  Person participating in another research protocol or having participated in another&#xD;
               research protocol in the 4 weeks preceding the inclusion visit&#xD;
  &#xD;
          Linked to botulinum toxin injections&#xD;
  &#xD;
            -  Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium&#xD;
               chloride)&#xD;
  &#xD;
            -  Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.)&#xD;
  &#xD;
            -  Presence of infection at injection site(s)&#xD;
  &#xD;
            -  General anesthesia less than one month ago&#xD;
  &#xD;
            -  Association with aminoglycosides and anti-cholinesterase agents (risk of increased&#xD;
               toxin effects)&#xD;
  &#xD;
            -  History of neurogenic damage such as polyradiculoneuritis&#xD;
  &#xD;
            -  History of dysphagia with esophageal or neurological stasis, swallowing disorders,&#xD;
               inhalation pneumonitis&#xD;
  &#xD;
            -  Botulinum toxin injections in the 3 months preceding the study&#xD;
  &#xD;
            -  Clinical anal examination suggestive of anorectal abscess&#xD;
  &#xD;
            -  Recent history (&lt;12 months) of myocardial infarction and/or rhythm disorders not&#xD;
               reduced by appropriate treatment&#xD;
  &#xD;
            -  Peripheral motor neuropathies (such as amyotrophic lateral sclerosis or motor&#xD;
               neuropathy) and underlying neurological disorders&#xD;
  &#xD;
            -  Current treatment with anticoagulants or anti-aggregants or haemostasis disorders&#xD;
               according to recommendations (SFED). When patients are on anticoagulant or&#xD;
               anti-aggregant therapy, the type of injections to be performed depends on the type of&#xD;
               anticoagulation and the patient's thrombo-embolic risk:&#xD;
  &#xD;
            -  Patients on anticoagulant or anti-aggregant therapy with a major thrombo-embolic risk&#xD;
               will not be included.&#xD;
  &#xD;
            -  Patients on anticoagulant or anti-aggregant therapy with a moderate or low&#xD;
               thrombo-embolic risk may be included. If patients are taking a vitamin K antagonist,&#xD;
               treatment will be continued provided that the INR is within the usual range of 2 to 3&#xD;
               (GETED, HAS, 2008). If patients are taking anti-aggregants, these can be continued&#xD;
               (SFED, HAS, 2012). If patients are taking new oral anticoagulants, they should take a&#xD;
               short break and not take the AOD the evening before or the morning of the injections&#xD;
               (GIHP, 2015).&#xD;
  &#xD;
          Linked to rectosigmoidoscopy&#xD;
  &#xD;
            -  Local pathology preventing colonoscopy (anal stenosis)&#xD;
  &#xD;
            -  Allergy or hypersensitivity to silicone and/or latex&#xD;
  &#xD;
          Linked to laxatives&#xD;
  &#xD;
            -  Contraindication to DULCOLAX® 5 mg, gastro-resistant coated tablet&#xD;
  &#xD;
            -  Contraindication to XIMEPEG®, powder for oral solution&#xD;
  &#xD;
          Linked to high-resolution manometry&#xD;
  &#xD;
            -  Clinically diagnosed intestinal obstruction&#xD;
  &#xD;
            -  Severe coagulopathy or oral anticoagulants&#xD;
  &#xD;
            -  Cardiac disorders for which vagal stimulation is poorly tolerated&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Charlotte DESPREZ</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rouen University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Charlotte DESPREZ</last_name>
      <phone>0232888039</phone>
      <email>charlotte.desprez@chu-rouen.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Univesity Hospital, Rouen</name>
        <address>
          <city>Rouen</city>
          <zip>76031</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Florian VALLIN</last_name>
        <phone>0232886697</phone>
        <email>florian.vallin@chu-rouen.fr</email>
      </contact>
      <contact_backup>
        <last_name>David MALLET</last_name>
        <phone>0232888265</phone>
        <email>secretariat.drc@chu-rouen.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Charlotte DESPREZ</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>27144630</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>22513438</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32740249</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>21689287</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26448532</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fecal Incontinence</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Botulinum Toxins</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998187
  org study id: 2021/0384/HP
  nct id: NCT05998187
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single arm
  primary purpose: Treatment
  masking: None (Open Label)
  measure: high amplitude propagative contractions
  time frame: before and 1 month after intrarectal botulinum toxin injections.
  description: 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.
  measure: Characteristics of contractions in the rectum and sigmoid
  time frame: before and 1 month after intrarectal botulinum toxin injections.
  description: Amplitude of contractions in the rectum and sigmoid
  measure: Probe expulsion
  time frame: before and 1 month after intrarectal botulinum toxin injections.
  description: Probe expulsion (which is an indirect sign of colorectal motricity efficiency) and time to probe expulsion.
  measure: Anal incontinence severity score
  time frame: before and 1 month after botulinum toxin injections.
  description: Anal incontinence severity score (Cleveland Score) and stool schedule before and 1 month after botulinum toxin injections.
  measure: Quality of life score
  time frame: before and 1 month after botulinum toxin injections.
  description: Quality of life score (FIQL Score, Appendix 4) before and 1 month after botulinum toxin injections.
  measure: Adverse events
  time frame: at each visit, during 4 months
  description: Adverse events will be collected at each visits
  arm group label: intra-rectal botulinum toxin injections
  arm group type: Experimental
  description: Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.
  intervention type: Drug
  intervention name: intra-rectal botulinum toxin injections
  description: Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.
  arm group label: intra-rectal botulinum toxin injections
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Charlotte DESPREZ
  role: Principal Investigator
  affiliation: Rouen University Hospital
  last name: Charlotte DESPREZ
  phone: 0232888039
  email: charlotte.desprez@chu-rouen.fr
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: France
  citation: 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: 27144630
  citation: 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: 22513438
  citation: 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: 32740249
  citation: 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: 21689287
  citation: 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: 26448532
  responsible party type: Sponsor
  mesh term: Fecal Incontinence
  mesh term: Botulinum Toxins
  sharing ipd: No