Impact of treatment for Fecal Incontinence on Constipation Symptoms.
Abstract
OBJECTIVE:Defecatory symptoms, such as sense of incomplete emptying and straining
with bowel movements, are paradoxically present in women with fecal incontinence (FI).
Treatments for FI, such as loperamide and biofeedback, can worsen or improve defecatory
symptoms, respectively. The primary aim of this study was to compare changes in constipation
symptoms in women undergoing treatment for FI with education only, loperamide, anal
muscle exercises with biofeedback, or both loperamide and biofeedback. Our secondary
aim was to compare changes in constipation symptoms among responders and non-responders
to FI treatment. METHODS:This was a planned secondary analysis of a randomized controlled
trial comparing 2 first-line therapies for FI in a 2x2 factorial design. Women with
at least monthly FI and normal stool consistency were randomized to 4 groups: 1) oral
placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus
anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback. Defecatory
symptoms were measured using the Patient Assessment of Constipation Symptoms (PAC-SYM)
questionnaire at baseline, 12 weeks and 24 weeks. The PAC-SYM consists of 12 items
that contribute to a global score and 3 subscales: stool characteristics/symptoms
(hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms
(burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort,
pain, bloating, cramps). Scores for each subscale as well as the global score range
from 0 (no symptoms) to 4 (maximum score), with negative change scores representing
improvement in defecatory symptoms. Responders to FI treatment were defined as women
with a minimally important clinical improvement of ≥5-points on the St. Mark's (Vaizey)
scale between baseline and 24 weeks. Intent-to-treat analysis was performed using
a longitudinal mixed model, controlling for baseline scores, to estimate changes in
PAC-SYM scores from baseline through 24 weeks. RESULTS:At 24 weeks, there were small
changes in PAC-SYM global scores in all four groups: oral placebo plus education (-0.3;
95% CI -0.5, -0.1), loperamide plus education (-0.1, 95% CI -0.3, 0.0), oral placebo
plus biofeedback (-0.3, 95% CI -0.4, -0.2), and loperamide plus biofeedback (-0.3,
95% CI -0.4, -0.2). No differences were observed in change in PAC-SYM scores between
women randomized to placebo plus education and those randomized to loperamide plus
education (p=0.17) or placebo plus biofeedback (p=0.82). Change in PAC-SYM scores
in women randomized to combination loperamide plus biofeedback therapy was not different
from that of women randomized to treatment with loperamide or biofeedback alone. Responders
had greater improvement in PAC-SYM scores than non-responders (-0.4; 95% CI -0.5,
-0.3 vs. -0.2; 95% CI -0.3, -0.0, p<0.01, mean difference 0.2, 95% CI 0.1, 0.4). CONCLUSION:Change
in constipation symptoms following treatment of FI in women are small and are not
significantly different between groups. Loperamide treatment for FI does not worsen
constipation symptoms among women with normal consistency stool. Women with clinically
significant improvement in FI symptoms report greater improvement in constipation
symptoms.
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Journal articlePermalink
https://hdl.handle.net/10161/19755Published Version (Please cite this version)
10.1016/j.ajog.2019.11.1256Publication Info
Andy, Uduak U; Jelovsek, J Eric; Carper, Benjamin; Meyer, Isuzu; Dyer, Keisha Y; Rogers,
Rebecca G; ... Pelvic Floor Disorders Network (2019). Impact of treatment for Fecal Incontinence on Constipation Symptoms. American journal of obstetrics and gynecology. 10.1016/j.ajog.2019.11.1256. Retrieved from https://hdl.handle.net/10161/19755.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
John E Jelovsek
Professor of Obstetrics and Gynecology
Dr. Jelovsek is the Director of Data Science for Women’s Health in Department of Obstetrics
& Gynecology (OBGYN) at Duke University. He is Board Certified in OBGYN by the American
Board of OBGYN and Board Certified in Female Pelvic Medicine & Reconstructive Surgery
by the American Board of OBGYN and American Board of Urology. He currently practices
Female Pelvic Medicine and Reconstructive Surgery (FPMRS). He has expertise in the
development and validation of “individualiz

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