Post Procedural Constipation | MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
Post Procedural Constipation research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Post Procedural Constipation
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MiraLaxMiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
Drug:PlaceboPlacebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
Drug:Rescue LaxativeAll 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboPlacebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
MiraLaxMiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
Start Date: September 2012
Completed Date: April 2015
Primary Outcome: Time to first postoperative bowel movement
Secondary Outcome: Other postoperative medication use
Study sponsors, principal investigator, and references
Principal Investigator: Anthony G Visco, MD
Lead Sponsor: Duke University
Collaborator: American Urogynecologic Society