MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
Launched by DUKE UNIVERSITY · Sep 20, 2012
Trial Information
Current as of June 08, 2025
Completed
Keywords
ClinConnect Summary
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 experien...
Gender
FEMALE
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
About Duke University
Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Patients applied
Trial Officials
Anthony G Visco, MD
Principal Investigator
Duke University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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