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Combination therapy with biofeedback, loperamide, and stool-bulking agents is effective for the treatment of fecal incontinence in women -- a randomized controlled trial
Sjodahl J, Walter SA, Johansson E, Ingemansson A, Ryn A-K, Hallbook O
Scandinavian Journal of Gastroenterology 2015 Aug;50(8):965-974
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence (FI). There is limited data comparing and combining these two treatments. The objective of this study was to evaluate the effect of biofeedback and medical treatments, separately and in combination. MATERIAL AND METHODS: Sixty-four consecutive female patients, referred to a tertiary centre for FI, were included. The patients were randomized to start with either biofeedback (4 to 6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination of treatments, ie, medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments. RESULTS: Fifty-seven patients completed the study. Median number of leakage episodes during two weeks decreased from 6 to 3 (p < 0.0001) from baseline to completion. The patients showed a significant (1) decrease in number of leakages without forewarning (p = 0.04); (2) decrease in number of stools with urgency (p = 0.001); (3) decrease in number of loose stool consistency; and (4) an increase in rectal sensory thresholds, both for maximum tolerable rectal pressure and first sensation (< 0.01). The combination treatment was superior to both single treatments in terms of symptoms and functions. There was no significant difference between the two groups at any time point. CONCLUSIONS: The combination therapy with biofeedback and medical treatment is effective for symptom relief in FI. The symptom improvement was associated with improved fecal consistency, reduced urgency, and increased rectal sensory thresholds.

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