Clinical Trial: Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse

Brief Summary: Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.

Detailed Summary:

Tissue destructive disorders are more common in smokers than in non-smokers. Alterations in wound healing and connective tissue turnover are suggested mechanisms, but exact details remain to be discovered. The synthesis of subcutaneous collagen in smokers is specifically impeded, and that smokers have less collagen compared to non-smokers. Jorgensen et al study showed that smokers tend to have less procollagen I N-propeptide (PINP) levels in the blood, less vitamin C and higher levels of matrix metalloproteinase (MMP-9), these findings reversed after smoking cessation.

Since smoking is one of the promoting and modifiable factors in the development of prolapse, understanding its effects on the support of pelvic organs may help modify the course of the POP condition in the future. Understanding the connective tissue effects of smoking using systemic markers of collagen metabolism in female smokers with prolapse may help future management and counseling of these patients. In addition, description of the markers of collagen metabolism in POP has not previously been documented.

Sponsor: TriHealth Inc.

Current Primary Outcome: Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism. [ Time Frame: One day- day of blood draw ]

Original Primary Outcome: Same as current

Current Secondary Outcome: • A secondary objective will be to determine whether women with pelvic organ prolapse are different than healthy controls with respect to the same systemic markers [ Time Frame: One day- day of blood draw ]

Original Secondary Outcome: Same as current

Information By: TriHealth Inc.

Dates:
Date Received: March 4, 2012
Date Started: March 2012
Date Completion:
Last Updated: October 15, 2014
Last Verified: February 2014