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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01548105
First received: March 4, 2012
Last updated: October 15, 2014
Last verified: February 2014

March 4, 2012
October 15, 2014
March 2012
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

These will include blood levels of the following:

  • Procollagen 1-N propeptide levels (PINP)
  • Matrix metalloproteinase (MMP9)
  • Plasma Vitamin C levels
Same as current
Complete list of historical versions of study NCT01548105 on ClinicalTrials.gov Archive Site
• 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with pelvic organ prolapse and without prolapse will be identified based on a manual review of patients in a tertiary care referral-based Urogynecology practice

Pelvic Organ Prolapse
Other: Blood draw for the study participants

These will include:

  • Procollagen 1-N propeptide levels (PINP)
  • Matrix metalloproteinase (MMP9)
  • Plasma Vitamin C levels
  • Prolapse and Smoker
    Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and have been smoking more than one pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
    Intervention: Other: Blood draw for the study participants
  • Prolapse and non smoker
    Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
    Intervention: Other: Blood draw for the study participants
  • No prolapse and smoker
    Patients in this arm, have been determined not to have prolapse and smokes more than 1 pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
    Intervention: Other: Blood draw for the study participants
  • No prolapse and non smoker
    Patients in this arm have been determined not to have prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels
    Intervention: Other: Blood draw for the study participants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
March 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01548105
Smoking and prolapse
No
TriHealth Inc.
TriHealth Inc.
Not Provided
Principal Investigator: Maria Victoria C Estanol, MD Good Samaritan Hospital
TriHealth Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP