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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548105
• Other study ID #: Smoking and prolapse
• Status: Completed
• Phase: N/A
• First received: March 4, 2012
• Last updated: October 15, 2014
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2014
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• 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	No