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Management of fecal incontinence - focus on a vaginal insert for bowel control.

ABSTRACT: Fecal incontinence, also referred to as accidental bowel leakage, is a debilitating condition that impacts quality of life in a significant number of women. Current treatments for fecal incontinence include behavioral modification, biofeedback, drug therapy, and invasive surgical procedures. However, these treatments have suboptimal efficacy due to patient adherence, variability of presentation across patients, cost, and additional health risks. A vaginal bowel control system (Eclipse™ System) was developed to offer a low-risk, effective, and patient-managed approach to treating accidental bowel leakage. The vaginal bowel control system consists of a vaginal insert and user-controlled, pressure-regulated pump. Once inflated, the balloon of the vaginal insert is directed posteriorly to occlude the rectum, allowing the woman to immediately regain control of bowel function. This article will introduce the design evolution and feasibility studies of the Eclipse System. In addition, this review will discuss the results from a recent clinical trial that demonstrated the safety and efficacy of the vaginal bowel control system in managing fecal incontinence and other symptoms of bowel dysfunction.

SUBMITTER: Sokol ER

PROVIDER: S-EPMC4869843 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Management of fecal incontinence - focus on a vaginal insert for bowel control.

Sokol Eric R ER

Medical devices (Auckland, N.Z.) 20160510

Fecal incontinence, also referred to as accidental bowel leakage, is a debilitating condition that impacts quality of life in a significant number of women. Current treatments for fecal incontinence include behavioral modification, biofeedback, drug therapy, and invasive surgical procedures. However, these treatments have suboptimal efficacy due to patient adherence, variability of presentation across patients, cost, and additional health risks. A vaginal bowel control system (Eclipse™ System) w ...[more]

PMID: 27274318

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Project description:Introduction and hypothesisTo evaluate change in fecal incontinence symptom severity after 8 weeks of darifenacin therapy in patients with double incontinence-urgency urinary incontinence (UUI) and fecal incontinence. Important secondary outcomes included fecal incontinence symptom distress and impact on quality of life, fecal incontinence episodes, global impression of improvement and overactive bladder symptom distress and impact.MethodsProspective open-label cohort study of women presenting primarily with UUI, diagnosed with double incontinence and electing antimuscarinic therapy for UUI. Women ≥ 18 years with moderate or greater bothersome UUI and fecal incontinence of liquid/solid stool with St. Marks (Vaizey) score ≥ 12 were included. Subjects were treated with darifenacin 15 mg daily for 8 weeks. The primary outcome was change in fecal incontinence symptom severity using the St. Marks (Vaizey) score after 8 weeks. Sample size was based on the minimally important difference of the St. Marks, -5, and standard deviation, ± 8.5; 30 subjects provided 80% power and type I error of 0.05, including a 15% attrition rate.ResultsThirty-two women were consented with mean baseline St. Marks (Vaizey) score of 18.0 ± 3.0. Mean age was 66.5 ± 10.3 years. Twenty-eight subjects (29/32, 87.5%) completed assessments. St. Marks (Vaizey) score significantly improved from 18.0 to 11.0 [mean difference - 7.0, 95% confidence interval (CI): -8.7, -5.3], and 19 subjects (19/32,67.9%) met the minimally important difference. Statistically significant improvements were also noted in fecal incontinence frequency, quality of life, and overactive bladder symptom bother and quality of life (all p < 0.01).ConclusionsDarifenacin can be considered a highly effective early intervention in women suffering from double incontinence.Clinical trial registrationBladder Antimuscarinic Medication and Accidental Bowel Leakage (BAMA), https://clinicaltrials.gov/ct2/show/NCT03543566 , NCT03543566.

Dataset Information

Management of fecal incontinence - focus on a vaginal insert for bowel control.

Publications

Management of fecal incontinence - focus on a vaginal insert for bowel control.

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