Objective Traditional surgical procedures for intractable idiopathic constipation are associated with a variable outcome and substantial morbidity. The symptomatic response, physiological effect and effect on quality of life of sacral nerve stimulation (SNS) were evaluated in patients with constipation (slow transit and normal transit with impaired evacuation).
Methods In a prospective study at five European sites patients who failed conservative treatment underwent 21 days test stimulation. Patients with >50% improvement in symptoms underwent permanent neurostimulator implantation. Primary end points were increased defecation frequency, decreased straining and decreased sensation of incomplete evacuation.
Results 62 patients (55 female, median age 40 years) underwent test stimulation, of whom 45 (73%) proceeded to chronic stimulation. 39 (87%) of these 45 patients achieved treatment success. After a median 28 (range 1–55) months follow-up, defecation frequency increased from 2.3 to 6.6 evacuations per week (p<0.001). Days per week with evacuation increased from 2.3 to 4.8 (p<0.001). There was a decrease in time spent toileting (10.5 to 5.7 min, p=0.001), straining (75–46% of successful evacuations, p<0.001), perception of incomplete evacuation (71.5–46% of successful evacuations, p<0.001) and subjective rating of abdominal pain and bloating (p<0.001). Cleveland Clinic constipation score (0=no to 30=severe constipation) decreased from 18 to 10 (p<0.001). Visual analogue scale (VAS) score (0=severe to 100=no symptoms) increased from 8 to 66 (p<0.001). Patients with slow and normal transit benefited. Quality of life significantly improved. Colonic transit normalised in half of those with baseline slow transit (p=0.014).
Conclusion SNS is effective in the treatment of idiopathic slow and normal transit constipation resistant to conservative treatment.
Clinical Trial Number NCT00200005.
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Podium presentation by Dr Thomas Dudding MD MRCS at Digestive Diseases Week, Washington, DC, USA, 19–24 May 2007.
Funding This study was sponsored and monitored by Medtronic Europe Sarl. The study design, analysis and interpretation of data and subsequent writing of this report were performed without the influence of Medtronic.
Competing interests Declared (the declaration can be viewed on the Gut website at http://www.gut.bmj.com/supplemental).
Ethics approval This study was conducted with the approval of the individual ethics committees at each research site.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
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