Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: One day- day of blood draw
These will include blood levels of the following: * Procollagen 1-N propeptide levels (PINP) * Matrix metalloproteinase (MMP9) * Plasma Vitamin C levels
次要结局
- • 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)