drugset / Trial / NCT05998187
Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-04-15
- Primary completion
- 2027-06-01
- Completion
- 2027-12-01
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin | Protein / enzyme biologic | — | Other |
Indications
No indication recorded.