A Phase 2 interventional study of sacral nerve modulation in Constipation, sponsored by University Hospital, Bordeaux. Completed at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-23.
Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment
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.
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 of a sacral nerve modulation test before considering a surgical treatment.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Constipation defined by at least two of the following criteria :
Exclusion Criteria:
After the definitive implantation, stimulators are placed in position OFF during 8 weeks. Then all the stimulators are switched OFF for 15 days. Finally stimulators are switched ON for the second arm during 8 weeks
Procedure: sacral nerve modulation
After the definitive implantation, stimulators are placed in position ON during 8 weeks. Then all the stimulators are switched OFF for 15 days. Finally stimulators are maintained in position OFF during 8 weeks
Procedure: sacral nerve modulation
After the definitive implantation, stimulators are placed in position ON (arm on-off) or OFF (arm off-on) for the first arm and in position OFF for the second arm during 8 weeks. Then all the stimulators are switched OFF (both first and second arms) for 15 days. Finally stimulators are maintained in position OFF for the first arm and switched ON for the second arm during 8 weeks
Percentage of patients showing a positive response to sacral nerve stimulation at 2 months
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
Time frame: 2 months of the stimualtion period
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
Efficacy of neuromodulation (percentage of positive responders) at 1 year
Time frame: 1 year after permanent implantation
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
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux