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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003650-14 | EudraCT Number |
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Fecal incontinence is a frequent pathology which concerns 10% of the general population and severely alters patients quality of life. The cost of urinary and faecal incontinence has been estimated to be $16 billions a year. Several treatments exist depending on the aetiology of the faecal incontinence: medical treatments, biofeedback and sacral nerve stimulation. Nevertheless, these treatments are not always effective (50-70% of success) and are not without side effects, particularly the sacral nerve stimulation (pain, infection, electrode displacement..).
The intravesical injections of botulinum toxin have been used for several years for the treatment of urinary incontinence with overactive bladder. Several randomized trials have demonstrated the efficacy of these injections in patients with neurological disorders and overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the detrusor muscle increase the compliance and the bladder capacity and delay the initial appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve afferents.
The botulinum toxin should play a role on motor afferents as well as on the sensory function of efferent nerves.
The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency episodes with improvement in quality of life, without any major side effects, in the patients included in this study. Nevertheless, the benefit of toxin injections are known to be temporary because of nerve re-growth. If we obtain similar results for fecal incontinence, it would be possible to schedule one to two injections a year because of the limited side-effects and invasiveness of the rectal injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal Injection of Botulinum toxin A | Experimental | Botulinum toxin A will be injected during rectoscopy for patient with rectal incontinence. Anorectal manometry will be performed for evaluation of efficacy of experimental drug |
|
| Rectal Injection of physiologic serum | Placebo Comparator | physiologic serum will be injected during rectoscopy for patient with rectal incontinence. Anorectal manometry will be performed for evaluation of efficacy of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectoscopy | Procedure | A rectoscopy will be performed for Botulinum toxin A or physiologic serum injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Number of active fecaI incontinence episodes per week | The number of fecaI incontinence episodes is evaluated using a bowel diary | 1 Month |
| Change from baseline in the Number of urgencies episodes per week | The number of urgencies episodes is evaluated using a bowel diary | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Imputability of Adverse events is evaluated by investigator | 6 Months |
| Number of Adverse Events | Imputability of Adverse events is evaluated by investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie LEROI, Pr | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | France | ||||
| Clinique des Cèdres |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38128556 | Derived | Leroi AM, Queralto M, Zerbib F, Siproudhis L, Vitton V, Amarenco G, Etienney I, Mion F, Bridoux V, Philip J, Brochard C, Damon H, Lacroix E, Gillibert A, Gourcerol G. Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):147-158. doi: 10.1016/S2468-1253(23)00332-1. Epub 2023 Dec 18. |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011351 | Proctoscopy |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Anorectal manometry | Procedure | Anorectal manometry will be performed to evaluate efficacy of Botulinum toxin A or physiologic serum rectal injection |
|
| Botulinum toxin A or physiologic serum injection | Drug | Botulinum toxin A or physiologic serum injection is performed during rectoscopy |
|
| 1 Month |
| Number of Adverse Events | Imputability of Adverse events is evaluated by investigator | 3 Months |
| Change from baseline in the severity of fecal incontinence | The severity of fecal incontinence is evaluated using Cleveland Clinic Score | 6 Months |
| Change from baseline in the severity of fecal incontinence | The severity of fecal incontinence is evaluated using Cleveland Clinic Score | 3 Months |
| Change from baseline in the severity of fecal incontinence | The severity of fecal incontinence is evaluated using Cleveland Clinic Score | 1 Month |
| Change from baseline on delay in postponing defecation | postponing defecation delay is evaluated using a bowel diary | 6 Months |
| Change from baseline on delay in postponing defecation | postponing defecation delay is evaluated using a bowel diary | 3 Months |
| Change from baseline on delay in postponing defecation | postponing defecation delay is evaluated using a bowel diary | 1 Month |
| Change from baseline in the Number of active fecaI incontinence episodes per week | The number of fecaI incontinence episodes and/or urgencies is evaluated using a bowel diary | 6 months |
| Change from baseline in the Number of active fecaI incontinence episodes per week | The number of fecaI incontinence episodes and/or urgencies is evaluated using a bowel diary | 3 months |
| Change from baseline in the Number of urgencies episodes per week | The number of urgencies episodes is evaluated using a bowel diary | 6 months |
| Change from baseline in the Number of urgencies episodes per week | The number of urgencies episodes is evaluated using a bowel diary | 3 months |
| Cornebarrieu |
| France |
| Hospices Civils de Lyon | Lyon | France |
| AP-HM Hôpital Nord | Marseille | France |
| AP-HP Hôpital Tenon | Paris | France |
| Hôpital des Diaconesses | Paris | France |
| Rennes University Hospital | Rennes | France |
| Rouen University Hospital | Rouen | 76031 | France |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |