Skip to main content
OpenTrials
Completed

NCT Number: NCT01548105

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

PROLAPSE group

  • More than 18 years old
  • Symptomatic POP at or beyond the hymen as determined by physical examination and a positive answer to the screening questions
  • For smoker group- smoke more than one pack per day
  • For non smoker group- non smoker for more than 7 years

No Prolapse group:

  • Absence of prolapse and negative answer to the screening questions

Exclusion criteria

  • Using Hormone Replacement Therapy (systemic estrogen, progesterone or testosterone)
  • Using vaginal estrogen (cream, ring, tablet)
  • Chronic steroid use
  • Past medical history of connective tissue disease
  • Scurvy, malabsorption, alcoholism, pregnancy, hyperthyroidism, liver disease and renal failure

Treatment and study plan

Blood draw for the study participants

Other

These will include:

  • Procollagen 1-N propeptide levels (PINP)
  • Matrix metalloproteinase (MMP9)
  • Plasma Vitamin C levels

Primary outcomes

  1. 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

    These will include blood levels of the following:

    • Procollagen 1-N propeptide levels (PINP)
    • Matrix metalloproteinase (MMP9)
    • Plasma Vitamin C levels

Secondary outcomes

  1. • 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

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2012
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.