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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborator:
American Urogynecologic Society
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01691742
First received: September 18, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Post Procedural Constipation
Drug: MiraLax
Drug: Placebo
Drug: Rescue Laxative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-Blind Randomized Controlled Trial of MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery in Women Receiving Routine Docusate Sodium

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Time to first postoperative bowel movement [ Time Frame: First postoperative week ] [ Designated as safety issue: No ]
    The primary outcome is time to first postoperative bowel movement (in hours, converted to days) based upon postoperative bowel diary. Time will be calculated based upon date and time of first postoperative bowel movement from start time of surgery.


Secondary Outcome Measures:
  • Other postoperative medication use [ Time Frame: First postoperative week ] [ Designated as safety issue: No ]
    Rescue laxative use, daily pain level and narcotic use will be obtained from postoperative bowel diaries.

  • Evaluation of symptoms and quality of life related to constipation [ Time Frame: First postoperative week ] [ Designated as safety issue: No ]
    The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM.

  • Symptoms of Over-Effectiveness [ Time Frame: First Postoperative Week ] [ Designated as safety issue: No ]
    Symptoms of over-effectiveness, including abdominal pain or cramping, bloating, loose stools, watery diarrhea and their impact on GI-related quality of life will be evaluated based upon bowel diaries, Bristol stool scales and the PAC-SYM and PAC-QOL questionnaires.

  • Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively [ Time Frame: 5-7 weeks postoperatively ] [ Designated as safety issue: No ]
    The investigators will evaluate BM quality based upon Bristol stool scale. Straining, abdominal or rectal pain, incomplete evacuation and the impact of these symptoms on GI-related quality of life will be assessed by the PAC-SYM and PAC-QOL validated questionnaires. The PAC-SYM is a validated 12-item questionnaire based upon the Rome criteria for constipation and is tailored to assess a change in symptoms following an intervention.2 This questionnaire has been previously used with success in studies with urogynecologic patients. The PAC-QOL is a validated 28-item questionnaire assessing quality-of-life issues, including burden of constipation on daily functioning and well-being. The Bristol stool scale, which is a visual BM rating scale from 1 to 7, provides a validated measure of gut transit time based upon the shape, consistency and appearance of BM.


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
Drug: Placebo
Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
Other Names:
  • Maltodextrin
  • Placebo
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.
Other Name: Milk of Magnesia
Active Comparator: MiraLax
MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
Drug: MiraLax
MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
Other Names:
  • PEG 3350
  • Polyethylene Glycol 3350
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.
Other Name: Milk of Magnesia

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691742

Contacts
Contact: Autumn L Edenfield, MD 919-401-1006 autumn.edenfield@dm.duke.edu
Contact: Jean Maynor, RN 919-401-1018 jean.maynor@dm.duke.edu

Locations
United States, North Carolina
Duke University, Department of Urogynecology Recruiting
Durham, North Carolina, United States, 27707
Contact: Autumn L Edenfield, MD    919-401-1006    autumn.edenfield@dm.duke.edu   
Contact: Jean Maynor, RN    919-401-1018    jean.maynor@dm.duke.edu   
Principal Investigator: Anthony G Visco, MD         
Sub-Investigator: Autumn L Edenfield, MD         
Sponsors and Collaborators
Duke University
American Urogynecologic Society
Investigators
Principal Investigator: Anthony G Visco, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01691742     History of Changes
Other Study ID Numbers: Pro00035126
Study First Received: September 18, 2012
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Postoperative constipation
Urogynecologic Surgery
MiraLax
Docusate Sodium

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Laxatives
Cathartics
Bismuth subsalicylate
Magnesium Hydroxide
Magnesium Oxide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014