MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate
postoperative period following pelvic reconstructive surgery in women taking routine docusate
sodium.
B. Objectives
1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between
MiraLAX versus placebo in women receiving routine docusate sodium after pelvic
reconstructive surgery.
Specific Aim 2: To compare patient reported outcomes of BM quality and associated
gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool
scale and the validated Patient Assessment of Constipation Symptom Questionnaire
(PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive
surgery.
Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo
utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire
(PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive
surgery.
2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent
constipation following pelvic reconstructive surgery by decreasing time to first BM,
decreasing GI symptoms associated with constipation, and increasing measures of
GI-related quality of life, while minimizing the bothersome side effects associated with
stimulant laxatives.