跳至主要内容
临床试验/NCT02495311
NCT02495311招募中不适用

The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms and Gastrointestinal Symptoms

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores

研究概览

简要总结

The aim of this study is to assess the relationship between adenomyosis/myoma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms.

详细描述

All outpatient patients were found to have >3 cm uterine myoma or adenomyosis were invited to participate in this study. The size and location of uterine myoma or adenomyosis and the uterus should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete overactive bladder symptom score, female bladder function (UDI-6 & IIQ-7), female sexual function index, and bowel incontinence assessment questionnaires. In addition, patients who underwent surgeries for myoma or adenomyosis will be requested to complete the above questionnaires at 3 months after surgery. Women with intact uterus should be assessed again by ultrasonography. At least 30 women with age and body mass index matched and without uterine myoma or adenomyosis will be invited to participate in this study as the control group.

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
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • >20 years old.
  • Myoma: women with >3 cm uterine myoma
  • Adenomyosis: women with uterus having several dark area (lacunar areas) in one uterine wall or thickening uterine wall
  • <The control group>
  • Inclusion criteria:
  • >20 years old.
  • Women without myoma or adenomyosis
  • <Both groups>

排除标准

  • The patient has a lower urinary tract infection or acute intestinal inflammation.
  • Previous surgery for the bladder or urethra.
  • History of urinary tract stones or tumors.

结局指标

主要结局

The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores

时间窗: 12 weeks

The Spearman's correlation between the size of uterine myoma and the score of Overactive Bladder Symptoms Scores

次要结局

  • The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea(12 weeks)
  • Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group(12 weeks)
  • Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Far Eastern Memorial Hospital

研究点 (1)

Loading locations...

相似试验