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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Other: Blood draw for the study participants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prolapse and Smoker<br>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<br>* These will include: Procollagen 1-N propeptide levels (PINP) Matrix metalloproteinase (MMP9) Plasma Vitamin C levels<br>|
| Prolapse and non smoker<br>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<br>* These will include: Procollagen 1-N propeptide levels (PINP) Matrix metalloproteinase (MMP9) Plasma Vitamin C levels<br>|
| No prolapse and smoker<br>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<br>* These will include: Procollagen 1-N propeptide levels (PINP) Matrix metalloproteinase (MMP9) Plasma Vitamin C levels<br>|
| No prolapse and non smoker<br>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<br>* These will include: Procollagen 1-N propeptide levels (PINP) Matrix metalloproteinase (MMP9) Plasma Vitamin C levels<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, smoking and collagen metabolism