Clinical trial NCT01548105: Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
Official title: Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
smoking and collagen metabolism
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: One day- day of blood draw
Secondary outcomes:
measure: • 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
timeFrame: One day- day of blood draw
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: Good Samaritan Hospital
name: Maria Victoria C Estanol, MD
role: PRINCIPAL_INVESTIGATOR
References: