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

This study is currently recruiting participants.
Verified December 2012 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
Maria Victoria Estanol, TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01548105
First received: March 4, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
 Other: Blood draw for the study participants

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • • 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 ]

Estimated Enrollment: 96
Study Start Date: March 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
 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 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
 Other: Blood draw for the study participants

These will include:

  • Procollagen 1-N propeptide levels (PINP)
  • Matrix metalloproteinase (MMP9)
  • Plasma Vitamin C levels
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
 Other: Blood draw for the study participants

These will include:

  • Procollagen 1-N propeptide levels (PINP)
  • Matrix metalloproteinase (MMP9)
  • Plasma Vitamin C levels
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
 Other: Blood draw for the study participants

These will include:

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548105

Contacts
Contact: Maria Victoria C Estanol, MD 513-862-4171 maria_estanol@trihealth.com

Locations
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Maria Victoria C Estanol, MD     513-862-4171     maria_estanol@trihealth.com    
Contact: Angela Fellner, PhD     513-862-2330     angie_fellner@trihealth.com    
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Maria Victoria C Estanol, MD Good Samaritan Hospital
  More Information

No publications provided

Responsible Party: Maria Victoria Estanol, MD, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01548105     History of Changes
Other Study ID Numbers: Smoking and prolapse
Study First Received: March 4, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
Pelvic organ prolapse
smoking and collagen metabolism

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Ascorbic Acid
Vitamins
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013