NCT01691742

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. 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.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 15, 2017

Status Verified

October 1, 2014

Enrollment Period

2.5 years

First QC Date

September 18, 2012

Last Update Submit

February 14, 2017

Conditions

Post Procedural Constipation

Keywords

Postoperative constipationUrogynecologic SurgeryMiraLaxDocusate Sodium

Outcome Measures

Primary Outcomes (1)

  • Time to first postoperative bowel movement

    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.

    First postoperative week

Secondary Outcomes (4)

  • Other postoperative medication use

    First postoperative week

  • Evaluation of symptoms and quality of life related to constipation

    First postoperative week

  • Symptoms of Over-Effectiveness

    First Postoperative Week

  • Evaluation of symptoms and quality of life related to constipation 6-weeks postoperatively

    5-7 weeks postoperatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Rescue Laxative

MiraLax

ACTIVE COMPARATOR

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

Drug: MiraLaxDrug: Rescue Laxative

Interventions

MiraLaxDRUG

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

Also known as: PEG 3350, Polyethylene Glycol 3350
MiraLax
PlaceboDRUG

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

Also known as: Maltodextrin
Placebo
Rescue LaxativeDRUG

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.

Also known as: Milk of Magnesia
MiraLaxPlacebo

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University, Department of Urogynecology

Durham, North Carolina, 27707, United States

Location

Related Publications (1)

  • 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.

    PMID: 27500338DERIVED

MeSH Terms

Interventions

polyethylene glycol 3350maltodextrinMagnesium Hydroxide

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesMagnesium Compounds

Study Officials

  • Anthony G Visco, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 25, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

February 15, 2017

Record last verified: 2014-10

Locations

US(1)