Clinical Trial: Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

Brief Summary: Subjects with refractory chronic constipation are offered two conventional therapeutic strategies: either medical treatment, either surgery (in the case of medication failure). Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the sacral nerve modulation. This procedure consists in stimulating the nerves which control the contractions of the colon and so the defecation phenomenon. Several open trials have suggested that sacral nerve modulation may be effective in reducing constipation and related symptoms. The aim of this randomized clinical trial is to assess the efficacy of the sacral nerve stimulation in patients with constipation.

Detailed Summary:

The prevalence of constipation is 2-27% in Western countries. For patients failing medical treatment (laxatives, biofeedback), a surgical solution may be considered (subtotal colectomy). But results are variable and it puts them at risk of functional sequelae.

Sacral nerve modulation is a minimally invasive procedure compared with the standard surgical support (colectomy) and reversible, which consists in two stages. First, a 3-week temporary stimulation test allows verifying the efficacy of neuromodulation. If the test is positive, the stimulating electrode is definitely implanted. Risks related to the procedure (infection, pain) are much smaller than those associated with a conventional surgical support.

Non comparative studies conducted with 19 and 62 patients showed that 40-73% of implanted patients have an improvement of their constipation and could benefit of permanent implantation with good results in medium term.

The primary objective of the investigators study is to evaluate the short-term efficacy (percentage of responders at 2 months) of sacral nerve modulation in the treatment of severe chronic constipation.

This is a cross-over designed, double-blinded, French multicenter clinical trial, including two periods: 2 months of stimulation ON and 2 months of stimulation OFF. Between these two periods, a 15-days period of "wash-out" will be respected during which all patients will be in OFF mode (4.5 months in total). This period of 4.5 months will be extended by a follow-up period of 7 months during which all patients will be treated (stimulation ON).

If this trial showed efficiency of this procedure, patients with severe refractory constipation could benefit
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Percentage of patients showing a positive response to sacral nerve stimulation at 2 months [ Time Frame: 2 months of the stimualtion period ]

Percentage of patients showing a positive response to sacral nerve stimulation during the period " ON " compared with the period " OFF " based on an objective assessment of the number of feces and their characteristics


Original Primary Outcome: Percentage of patients showing a positive response to sacral nerve stimulation at 2 months [ Time Frame: 2 months of the stimualtion period ]

Percentage of patients showing a positive response to sacral nerve stimulation during the period " ON " compared with the period " OFF "


Current Secondary Outcome:

  • Clinical characteristics, manometry data, Wexner score of responders to stimulation during the temporary stimulation test (period before the permanent implantation) [ Time Frame: 3 weeks between temporary and permanent implantations ]
  • Clinical characteristics, manometry data, Wexner score of responders to short-term stimulation [ Time Frame: 2 months after permanent implantation ]
  • Efficacy of neuromodulation [ Time Frame: 1 year after permanent implantation ]
    Efficacy of neuromodulation (percentage of positive responders) at 1 year
  • Manometry data, Wexner, QoL and EVA scores, time of colonic transit of responders to prolonged stimulation [ Time Frame: 1 year after permanent implantation ]
  • To evaluate the investigator opinion about the neuromodulation response, using the patient diary. [ Time Frame: 1 year after permanent implantation ]


Original Secondary Outcome:

  • Clinical characteristics, manometry data, Wexner score of responders to stimulation during the temporary stimulation test (period before the permanent implantation) [ Time Frame: 3 weeks between temporary and permanent implantations ]
  • Clinical characteristics, manometry data, Wexner score of responders to short-term stimulation [ Time Frame: 2 months after permanent implantation ]
  • Efficacy of neuromodulation [ Time Frame: 1 year after permanent implantation ]
    Efficacy of neuromodulation (percentage of positive responders) at 1 year
  • Manometry data, Wexner, QoL and EVA scores, time of colonic transit of responders to prolonged stimulation [ Time Frame: 1 year after permanent implantation ]


Information By: University Hospital, Bordeaux

Dates:
Date Received: June 11, 2012
Date Started: June 2012
Date Completion:
Last Updated: July 22, 2015
Last Verified: July 2015