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      Randomized clinical trial of sacral nerve stimulation for refractory constipation

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          Abstract

          Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT.

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          Most cited references18

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          An epidemiological survey of constipation in canada: definitions, rates, demographics, and predictors of health care seeking.

          The prevalence of functional constipation is highly variable among epidemiological surveys and may relate to the definitions applied. We estimated the population prevalence of self-reported, Rome I-defined, and Rome II-defined constipation in Canada and determined the variables that best predicted health care seeking. A research firm was employed to conduct a random digit dial national survey, inviting household members at least 18 yr of age to participate in a study assessing personal health issues. The sample was stratified to ensure that each region of Canada was represented. Data collection involved three stages: 1) recruitment of participants by phone, 2) mailing of the questionnaire, and 3) data retrieval through a follow-up phone call. The Rome II questionnaire was used to derive the prevalence of functional constipation using both Rome I and Rome II criteria. Of the 1149 participants, 27.2% self-reported constipation within the past 3 months, and 16.7% and 14.9% had functional constipation according to Rome I and II, criteria, respectively. For all three definitions, the rate for women was close to twice that for men. Approximately 34% of those with self-reported constipation had visited a physician for it, versus 26.3% of Rome II subjects. In a regression model, subjects self-reporting in the past 3 months were more likely to have seen a doctor for their constipation (odds ratio 2.47, p < 0.01) and significantly more women than men (35.6% vs 19.5%, p < 0.05). Functional constipation and related health care seeking are common in the Canadian population and are strongly determined by the definition used. The Rome II criteria for this disorder seem to be satisfactory, but modifications may be considered to allow for constipated subjects taking laxatives and to increase the number of qualifying symptoms.
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            Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features.

            Constipation is a common heterogeneous condition, possibly encompassing different clinical subtypes. Little is known about the comparative epidemiology of constipation subtypes. This study was conducted to estimate the prevalence of constipation subtypes and determine whether subtypes differ by sociodemographic factors. Between June and September 1997, a telephone interview was conducted with individuals about their bowel habits in the preceding 3 months. Survey data on 15 constipation-related symptoms were used to identify individuals who met prespecified symptom criteria for the following mutually exclusive subgroups: functional constipation, irritable bowel syndrome (IBS), outlet obstruction or delay (outlet), both IBS and outlet (IBS-outlet), and frequent laxative users (i.e., at least every other day). A total of 10,018 eligible individuals in the United States 18 yr of age or older completed the interview. Test-retest reliability of reporting symptoms was assessed in a separate national survey. The Spearman's correlation coefficient for reporting symptoms ranged from 0.54 to 0.83; all but three symptoms had correlations above 0.68. The overall prevalence of constipation was 14.7%. By subtype, prevalence was 4.6% for functional, 2.1% for IBS, 4.6% for outlet, and 3.4% for IBS-outlet. An additional 1.8% of respondents reported laxative use at least every other day. Outlet was the most common subtype among women, whereas functional constipation was the most common subtype among men. The gender ratio varied by subtype, with elevated ratios for outlet (F/M = 1.65) and IBS-outlet (F/M = 2.27) subtypes. The age pattern differed among each of the four subtypes. Prevalence of functional subtype decreased with increasing age. In contrast, outlet subtype did not seem to vary by age, and IBS (both men and women) and IBS-outlet (women only) subtypes increased to age 35 yr and declined thereafter. Prevalence of functional constipation increased with increasing education. Outlet type was more common in nonwhites compared to whites. Finally, 45% of individuals with constipation reported having the condition for 5 yr or more. Constipation is a heterogeneous condition. Differences in epidemiological profile by age, sex ratio, and relation to other sociodemographical factors support the distinction of two and possibly more symptom-based subtypes.
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              Sacral nerve stimulation for intractable constipation.

              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). 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. 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). 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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                Author and article information

                Journal
                British Journal of Surgery
                Br J Surg
                Wiley-Blackwell
                00071323
                February 2017
                February 2017
                : 104
                : 3
                : 205-213
                Affiliations
                [1 ]the CONSTIMOD study investigators
                Article
                10.1002/bjs.10326
                27779312
                ab0005c3-d0ca-407f-b148-47723eb54bac
                © 2017

                http://doi.wiley.com/10.1002/tdm_license_1

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