Clinical Trial: Effect and Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect And Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence

Brief Summary:

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 i

Detailed Summary:
Sponsor: University Hospital, Rouen

Current Primary Outcome:

• Change from baseline in the Number of active fecaI incontinence episodes per week [ Time Frame: 1 Month ]
  The number of fecaI incontinence episodes is evaluated using a bowel diary
• Change from baseline in the Number of urgencies episodes per week [ Time Frame: 1 Month ]
  The number of urgencies episodes is evaluated using a bowel diary

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of Adverse Events [ Time Frame: 6 Months ]
  Imputability of Adverse events is evaluated by investigator
• Number of Adverse Events [ Time Frame: 1 Month ]
  Imputability of Adverse events is evaluated by investigator
• Number of Adverse Events [ Time Frame: 3 Months ]
  Imputability of Adverse events is evaluated by investigator
• Change from baseline in the severity of fecal incontinence [ Time Frame: 6 Months ]
  The severity of fecal incontinence is evaluated using Cleveland Clinic Score
• Change from baseline in the severity of fecal incontinence [ Time Frame: 3 Months ]
  The severity of fecal incontinence is evaluated using Cleveland Clinic Score
• Change from baseline in the severity of fecal incontinence [ Time Frame: 1 Month ]
  The severity of fecal incontinence is evaluated using Cleveland Clinic Score
• Change from baseline on delay in postponing defecation [ Time Frame: 6 Months ]
  postponing defecation delay is evaluated using a bowel diary
• Change from baseline on delay in postponing defecation [ Time Frame: 3 Months ]
  postponing defecation delay is evaluated using a bowel diary
• Change from baseline on delay in postponing defecation [ Time Frame: 1 Month ]
  postponing defecation delay is evaluated using a bowel diary
• Change from baseline in the Number of active fecaI incontinence episodes per week [ Time Frame: 6 months ]
  The number of fecaI incontinence episodes and/or urgencies is evaluated using a bowel diary
• Change from baseline in the Number of active fecaI incontinence episodes per week [ Time Frame: 3 months ]
  The number of fecaI incontinence episodes and/or urgencies is evaluated using a bowel diary
• Change from baseline in the Number of urgencies episodes per week [ Time Frame: 6 months ]
  The number of urgencies episodes is evaluated using a bowel diary
• Change from baseline in the Number of urgencies episodes per week [ Time Frame: 3 months ]
  The number of urgencies episodes is evaluated using a bowel diary

Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: April 1, 2015
Date Started: December 2015
Date Completion: July 2019
Last Updated: December 6, 2016
Last Verified: December 2016