Surgical Treatment of Patients with Constipation and Fecal Incontinence

Gladman, Marc A.; Knowles, Charles H.

doi:10.1016/j.gtc.2008.06.009

Cited by 26 publications

(27 citation statements)

References 102 publications

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“…17 Despite largely favourable data, SNS requires two operations and is not without risk of morbidity. 29 Although it is cost-effective compared with other surgical options, 30 SNS does have high associated costs, recently estimated as £20,484 for the first 10 years of a patient's treatment, 31,32 because of the combination of equipment, hospital admission and ongoing care.…”

Section: Management Of Faecal Incontinencementioning

confidence: 99%

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Horrocks

Bremner

Stevens

et al. 2015

Health Technol Assess

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BackgroundFaecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life. When conservative strategies fail, treatment options are limited. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive outpatient treatment, shown in preliminary case series to have significant effectiveness; however, no randomised controlled trial has been conducted.ObjectivesTo assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed.DesignMulticentre, parallel-arm, double-blind randomised (1 : 1) controlled trial.SettingEighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders.ParticipantsParticipants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention.InterventionsPTNS was delivered via the Urgent®PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturer’s protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation.Main outcome measuresOutcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved ≥ 50% reduction in weekly faecal incontinence episodes (FIEs).ResultsIn total, 227 patients were randomised from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: seven from the PTNS arm and five from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a ≥ 50% reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38%) compared with 32 in the sham arm (31%) [odds ratio 1.28, 95% confidence interval (CI) 0.72 to 2.28;p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta –2.3, 95% CI –4.2 to –0.3;p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Mark’s Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported.ConclusionsPTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50% reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied. Further research will concentrate on particular subgroups of patients, for example those with pure urge FI.Trial registrationCurrent Controlled Trials ISRCTN88559475.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.

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Section: Management Of Faecal Incontinencementioning

confidence: 99%

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Horrocks

Bremner

Stevens

et al. 2015

Health Technol Assess

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“…The mechanism of action of the SNS is not understood, because continence has improved without a change in anal sphincter function [39]. Although it was initially believed that a morphologically intact sphincter was a prerequisite for SNS, this is no longer considered the case.…”

Section: Fecal Incontinencementioning

confidence: 99%

Common anorectal disorders: Diagnosis and treatment

Lacy

Weiser²

2009

Curr Gastroenterol Rep

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Anorectal disorders affect men and women of all ages. Their management is not limited to the evaluation and treatment of hemorrhoids. Rather, a spectrum of anorectal disorders ranges from benign and irritating (pruritus ani) to potentially life-threatening (anorectal cancer). Symptoms are nonspecific, which can make the evaluation of patients difficult. In addition, treatment can be frustrating because clinicians are hamstrung by a lack of well-designed, prospective, clinical trials. Some of the most common anorectal disorders include fecal incontinence, pelvic floor dyssynergia, anal fissures, pruritus ani, proctalgia fugax, and solitary rectal ulcer syndrome. This article provides an update on the evaluation and treatment of common anorectal disorders.

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“…FI may also contribute to the decision to place older patients into assisted living facilities 8 . However, despite its high prevalence, its deleterious impact on quality of life, and the availability of effective medical and surgical treatments 9;10 , surveys suggest that only 10% 7 to 30% 11 of people with FI have discussed this with their physician.…”

Section: Introductionmentioning

confidence: 99%

Fecal incontinence in primary care: prevalence, diagnosis, and health care utilization

Dunivan

Heymen

Palsson

et al. 2010

American Journal of Obstetrics and Gynecology

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Objective To estimate the frequency of self-reported fecal incontinence (FI), identify what proportion of these patients have a diagnosis of FI in their medical record, and compare healthcare costs and utilization in patients with different severities of FI to those without FI. Study Design Patients in a healthcare maintenance organization were eligible and 1707 completed a survey. Patients with self-reported FI were assessed for a diagnosis of FI in their medical record for the last five years. Healthcare costs and utilization were obtained from claims data. Results Fecal incontinence was reported by 36.2% of primary care patients, but only 2.7% of patients with FI had a medical diagnosis. FI adversely affected quality of life and severe FI was associated with 55% higher healthcare costs (including 77% higher gastrointestinal-related healthcare costs) compared to continent patients. Conclusions Increased screening of FI is needed.

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Surgical Treatment of Patients with Constipation and Fecal Incontinence

Cited by 26 publications

References 102 publications

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

Common anorectal disorders: Diagnosis and treatment

Fecal incontinence in primary care: prevalence, diagnosis, and health care utilization

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