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

NCT01548105 | Completed

• 1 other identifier: Smoking and prolapse
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; smoking and collagen metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• • 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

Study Arms (4)

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

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

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

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

Interventions

Blood draw for the study participants OTHER

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

No prolapse and non smoker; No prolapse and smoker; Prolapse and Smoker; Prolapse and non smoker

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Smoking

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maria Victoria C Estanol, MD

  Good Samaritan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2012
• First Posted: March 8, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 17, 2014

Record last verified: 2014-02

Locations

US (1)