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

TriHealth

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Other: Blood draw for the study participants

Study type: Observational

Funder types: Other

Identifiers

NCT01548105

Smoking and prolapse

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

96 participants in 4 patient groups

Prolapse and Smoker

Description:

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

Treatment:

Other: Blood draw for the study participants

Prolapse and non smoker

Description:

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

Treatment:

Other: Blood draw for the study participants

No prolapse and smoker

Description:

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

Treatment:

Other: Blood draw for the study participants

No prolapse and non smoker

Description:

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

Treatment:

Other: Blood draw for the study participants