Clinical trial NCT01691742: MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
Official title: Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Procedural Constipation
Keywords: Postoperative constipation
Urogynecologic Surgery
MiraLax
Docusate Sodium
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
First posted: 2012-09-25
Enrollment: 131
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first postoperative bowel movement
timeFrame: First postoperative week
Secondary outcomes:
measure: Other postoperative medication use
timeFrame: First postoperative week
measure: Evaluation of symptoms and quality of life related to constipation
timeFrame: First postoperative week
measure: Symptoms of Over-Effectiveness
timeFrame: First Postoperative Week
measure: Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively
timeFrame: 5-7 weeks postoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University, Department of Urogynecology
state: North Carolina
Study officials:
affiliation: Duke University
name: Anthony G Visco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edenfield AL, Siddiqui NY, Wu JM, Dieter AA, Garrett MA, Visco AG. Polyethylene Glycol 3350 and Docusate Sodium Compared With Docusate Sodium Alone After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2016 Sep;128(3):543-9. doi: 10.1097/AOG.0000000000001565.