MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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This is a randomized double-blind placebo-controlled clinical trial of MiraLAX versus placebo in women undergoing pelvic reconstructive surgery receiving routine docusate sodium. Subjects will be screened for eligibility during their preoperative visits and once enrolled, they will be randomized to receive MiraLAX or placebo starting on postoperative day (POD) 1 and continuing through POD 5. Subjects will be instructed to stop taking this medication if they experience any diarrhea. Subjects in both arms will be instructed to take milk of magnesia as a rescue laxative if they do not experience a BM by the morning of POD 6. All subjects will be provided a 30 day supply of docusate sodium and be instructed to begin this medication on POD 1.

Conditions

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Post Procedural Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Rescue Laxative

Intervention Type DRUG

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.

MiraLax

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

Group Type ACTIVE_COMPARATOR

MiraLax

Intervention Type DRUG

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

Rescue Laxative

Intervention Type DRUG

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.

Interventions

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MiraLax

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

Intervention Type DRUG

Placebo

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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PEG 3350 Polyethylene Glycol 3350 Maltodextrin Milk of Magnesia

Eligibility Criteria

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Inclusion Criteria

* English-speaking female patients
* \> 18 years of age
* Not pregnant (patients of childbearing potential will have a serum pregnancy test done pre-operatively as part of their surgical planning)
* Undergoing surgery for pelvic organ prolapse or stress urinary incontinence
* Recruited from the Duke University Division of Urogynecology

Exclusion Criteria

* Allergy/hypersensitivity to study medications
* Cardiac or renal disease
* Takes chronic daily laxatives
* Excluded if unable to complete at least 5 days of a 7 day baseline bowel diary
* Excluded if mesh resection or Interstim procedure
* Excluded if concurrent surgery includes anal sphincteroplasty or rectovaginal fistula repair

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No