Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections
NCT05998187 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-01-22
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.
Conditions
- Fecal Incontinence
Interventions
- DRUG
-
intra-rectal botulinum toxin injections
Patients with fecal incontinence who have failed conservative treatments and are candidates for intra-rectal botulinum toxin injections.
Sponsors & Collaborators
-
University Hospital, Rouen
lead OTHER
Principal Investigators
-
Charlotte DESPREZ · University Hospital, Rouen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-15
- Primary Completion
- 2027-06-01
- Completion
- 2027-12-01
Countries
- France
Study Locations
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