Clinical Trial: The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms and Gastrointestinal Symptoms
Brief Summary: The aim of this study is to assess the relationship between adenomyosis/myoma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms.
Detailed Summary: 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.
Sponsor: Far Eastern Memorial Hospital
Current Primary Outcome: The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea [ Time Frame: 12 weeks ]The Spearman's correlation between the size of uterine myoma and the presence of constipation/diarrhea
- Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group [ Time Frame: 12 weeks ]Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group by Wilcoxon rank-sum test
- Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group [ Time Frame: 12 weeks ]Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group by Chi-square test or Fisher's exact test
Original Secondary Outcome: Same as current
Information By: Far Eastern Memorial Hospital
Dates:
Date Received: July 4, 2015
Date Started: November 2014
Date Completion: December 2017
Last Updated: September 4, 2016
Last Verified: September 2016