Polyethylene Glycol 3350 and Docusate Sodium Compared With Docusate Sodium Alone After Urogynecologic Surgery: A Randomized Controlled Trial.
Edenfield, Autumn L. MD; Siddiqui, Nazema Y. MD, MHSc; Wu, Jennifer M. MD, MPH; Dieter, Alexis A. MD; Garrett, Melissa A. MD; Visco, Anthony G. MD
Obstetrics & Gynecology.
128(3):543-549, September 2016.
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OBJECTIVE: To compare time to first bowel movement and additional gastrointestinal outcomes between women receiving polyethylene glycol 3350 (PEG3350) and docusate sodium and docusate sodium alone after urogynecologic surgery.
METHODS: Participants received twice-daily 100 mg docusate sodium and were randomized to daily 1) PEG3350 or 2) inert placebo for 5 days after urogynecologic surgery. They completed bowel diaries, Bristol stool scale, validated Patient Assessment of Constipation Symptom Questionnaire, and Patient Assessment of Constipation Quality-of-Life Questionnaire preoperatively and 1 week after surgery. Our primary outcome was time to first bowel movement after surgery. To detect a 1-day difference in time to first bowel movement (4 compared with 3 days), 63 participants were needed in each group.
RESULTS: From September 2012 through March 2015, 145 women were randomized and 131 (90%) analyzed: 66 received PEG3350, and 65 received placebo. Polyethylene glycol 3350 did not significantly reduce time to first bowel movement after surgery compared with placebo (2.77 days [interquartile range 1.86-3.40] compared with 2.92 days [interquartile range 1.85-4.02] P=.25). Women in the PEG3350 group were less likely to take additional laxatives postoperatively, and the PEG3350 group was more adherent to the study drug regimen. Questionnaire scores, fecal incontinence, and urgency were similar between groups.
CONCLUSION: In women taking routine docusate sodium after urogynecologic surgery, adding PEG3350 postoperatively did not reduce time to first bowel movement.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01691742.
(C) 2016 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.