Clinical Trial: The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery: a Randomized Double Blinded Placebo Controlled Trial

Brief Summary: We are doing this study to see if using an over the counter mild laxative, SennaS, there is a difference in time required to have a bowel movement in women who are having surgery for prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or incontinence (when you leak urine or stool without your control) as compared to a sugar pill or placebo.

Detailed Summary: Right now, doctors use mild laxatives and stool softeners to help you have a bowel movement earlier and with less pain after surgery. Sometimes if the stool softener or mild laxatives do not work, you may need to use stronger laxatives or enemas. We want to see if specifically using SennaS is better for having a bowel movement soon after surgery and with less pain. SennaS is FDA approved for constipation. It has a stool softener and a mild laxative and has been shown to be safe and effective for treating constipation.
Sponsor: Hartford Hospital

Current Primary Outcome: 1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period. [ Time Frame: 7 weeks post-operatively ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Straining and pain with bowel movements in the immediate post-operative period [ Time Frame: First post-operative week ]

Original Secondary Outcome: Same as current

Information By: Hartford Hospital

Dates:
Date Received: December 10, 2007
Date Started: January 2008
Date Completion:
Last Updated: January 3, 2012
Last Verified: January 2012