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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: Blood draw for the study participants

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.

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	These will include blood levels of the following: Procollagen 1-N propeptide levels (PINP); Matrix metalloproteinase (MMP9); Plasma Vitamin C levels	One day- day of blood draw

Secondary Outcome Measures

Outcome Measure	Time Frame
• 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	One day- day of blood draw

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Maria Victoria C Estanol, MD, Good Samaritan Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 4, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): October 17, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; smoking and collagen metabolism
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Smoking and prolapse