跳至主要内容
临床试验/NCT04525105
NCT04525105已完成不适用

ARE SMAD2, SMAD3 AND TGF-β GENE EXPRESSION VALUABLE IN THE MANAGEMENT OF THE URGE URINARY INCONTINENCE?

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
SMAD3

研究概览

简要总结

Urge urinary incontinence (UUI) is a common health problem. Changes in collagen metabolism in pelvic support organs, such as uterosacral ligaments (USLs), might be responsible for the complex pathophysiology of UUI. The TGF-β pathway is involved in collagen synthesis and degradation. The Transforming Growth Family- β (TGF-β) superfamily has essential intracellular signaling components, such as newly identified SMAD family members. We evaluated the changes in the levels of TGF-β and SMAD gene and protein expression in the USL of patients with concomitant pelvic organ prolapse (POP) and UUI.

详细描述

This study included 10 patients who had been diagnosed with POP and UUI in the study group and 14 asymptomatic women without complaints of POP and UUI in the control group. Biopsy samples were collected from bilateral USL tissues during vaginal or abdominal hysterectomy. Total RNA was extracted from USL tissue and analyzed by qPCR. The protein expression levels were also analyzed with ELISA.

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

入选标准

  • patients who had been diagnosed with POP and UUI
  • asymptomatic women without complaints of POP and UUI

排除标准

  • Women who have SUI,
  • a history of gynecologic malignancy,
  • endometriosis,
  • connective tissue disorders,
  • previous pelvic inflammatory disease,
  • pelvic radiation anamnesis,
  • previous surgery for POP or UI,
  • those on steroid therapy and hormone replacement therapy

结局指标

主要结局

SMAD3

时间窗: intraoperative

tissue expression and protein level

TGF-ß1 mRNA Expression Levels

时间窗: intraoperative

tissue expression and protein level

SMAD2

时间窗: intraoperative

tissue expression and protein level

次要结局

未报告次要终点

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melike Nur AKIN

Dr Melike Nur Akın

Muğla Sıtkı Koçman University

研究点 (1)

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