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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01548105
Enrollment
96
Registered
2012-03-08
Start date
2012-03-31
Completion date
2013-03-31
Last updated
2014-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse, smoking and collagen metabolism

Brief summary

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

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.

Interventions

OTHERBlood draw for the study participants

These will include: * Procollagen 1-N propeptide levels (PINP) * Matrix metalloproteinase (MMP9) * Plasma Vitamin C levels

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.One day- day of blood drawThese will include blood levels of the following: * Procollagen 1-N propeptide levels (PINP) * Matrix metalloproteinase (MMP9) * Plasma Vitamin C levels

Secondary

MeasureTime 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 markersOne day- day of blood draw

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026