Abstract
Purpose
The purpose of this study is to compare the effectiveness and cost of home electrical stimulation and standardized biofeedback training in females with fecal incontinence
Methods
Thirty-six females suffering from fecal incontinence were randomized into two groups, matched for mean age (67.45 ± 7.2 years), mean body mass index (kg/m2) (26.2 ± 3.9), mean disease duration (4.1 ± 0.8 years), mean number of births (2.7 ± 1.3), and reports of obstetric trauma (25 %). Questionnaires were used to evaluate their demographics, medical, and childbearing history. Subjects were randomized to home electrical stimulation or standardized biofeedback training for a period of 6 weeks.
Subjective outcome measures included the frequency of fecal, urine, and gas incontinence by visual analog scale, Vaizey incontinence score, and subjects’ levels of fecal incontinence related anxiety. Objective outcome measures included pelvic floor muscle strength assessed by surface electromyography. We also compared the cost of each treatment modality.
Results
Only females who received home electrical stimulation (HES) reported a significant improvement in Vaizey incontinence score (p = 0.001), anxiety (p = 0.046), and in frequency of leaked solid stool (p = 0.013). A significant improvement in pelvic floor muscle strength was achieved by both groups. HES was much cheaper compared to the cost of standardized biofeedback training (SBT) (US$100 vs. US$220, respectively).
Our study comprised a small female population, and the study endpoints did not include objective measures of anorectal function test, such as anorectal manometry, before and after treatment.
Conclusions
Home electrical stimulation may offer an alternative to standardized biofeedback training as it is effective and generally well-tolerated therapy for females with fecal incontinence.
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The authors have no competing interest to declare and no grant support was received.
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CONSORT 2010 checklist of information to include when reporting a randomized trial*
*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomized trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming for those and for up-to-date references relevant to this checklist, see www.consort-statement.org
Nira Cohen-Zubary and Rachel Gingold-Belfer contributed equally to this work.
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Cohen-Zubary, N., Gingold-Belfer, R., Lambort, I. et al. Home electrical stimulation for women with fecal incontinence: a preliminary randomized controlled trial. Int J Colorectal Dis 30, 521–528 (2015). https://doi.org/10.1007/s00384-015-2128-7
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DOI: https://doi.org/10.1007/s00384-015-2128-7