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MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery

NCT01691742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2017-02-15

No results posted yet for this study

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.

Conditions

  • Post Procedural Constipation

Interventions

DRUG

MiraLax

MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery

DRUG

Placebo

Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery

DRUG

Rescue Laxative

All participants will be instructed to take Milk of Magnesia with standard over-the-counter dosing as a recue laxative if the subject has not had a bowel movement by postoperative day 6.

Sponsors & Collaborators

  • American Urogynecologic Society

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Anthony G Visco, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691742 on ClinicalTrials.gov