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.
RCT Entities:
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.
Authors: Adil E Bharucha; Alan R Zinsmeister; G Richard Locke; Barbara M Seide; Kimberly McKeon; Cathy D Schleck; L Joseph Melton Journal: Gastroenterology Date: 2005-07 Impact factor: 22.682
Authors: Marije Deutekom; Maaike P Terra; Annette C Dobben; Marcel G W Dijkgraaf; Richelle J F Felt-Bersma; Jaap Stoker; Patrick M M Bossuyt Journal: Dis Colon Rectum Date: 2005-12 Impact factor: 4.585