Health TrialsbyHealthPanel

Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections

ConditionFecal Incontinence
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • intra-rectal botulinum toxin injections

    Drug

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

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: intra-rectal botulinum toxin injectionsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
before and 1 month after intrarectal botulinum toxin injections.

Secondary outcomes

1

Characteristics of contractions in the rectum and sigmoid

Amplitude of contractions in the rectum and sigmoid

Time frame
before and 1 month after intrarectal botulinum toxin injections.
2

Probe expulsion

Probe expulsion (which is an indirect sign of colorectal motricity efficiency) and time to probe expulsion.

Time frame
before and 1 month after intrarectal botulinum toxin injections.
3

Anal incontinence severity score

Anal incontinence severity score (Cleveland Score) and stool schedule before and 1 month after botulinum toxin injections.

Time frame
before and 1 month after botulinum toxin injections.
4

Quality of life score

Quality of life score (FIQL Score, Appendix 4) before and 1 month after botulinum toxin injections.

Time frame
before and 1 month after botulinum toxin injections.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov
Apply now