MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery (MVP)

Duke University

Status: Completed

Conditions: Post Procedural Constipation

Treatments: Drug: MiraLax; Drug: Rescue Laxative; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01691742

Pro00035126

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 131 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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131 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Rescue Laxative

MiraLax

Active Comparator group

Description:

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

Treatment:

Drug: Rescue Laxative

Drug: MiraLax