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Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections in Patients With Fecal Incontinence

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Univesity Hospital, Rouen
RECRUITING
Rouen
Contact Information
Primary
Charlotte DESPREZ
charlotte.desprez@chu-rouen.fr
0232888039
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 21
Treatments
Experimental: intra-rectal botulinum toxin injections
Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov