Brief Title
The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
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 Description
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.
Study Type
Observational
Primary Outcome
The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores
Secondary Outcome
The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea
Condition
Adenomyosis
Intervention
myomectomy or adenomyomectomy
Study Arms / Comparison Groups
Women with uterine myoma
Description: Women with uterine myoma
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
150
Start Date
November 15, 2014
Completion Date
December 31, 2022
Primary Completion Date
December 31, 2022
Eligibility Criteria
Inclusion Criteria: 1. >20 years old. 2. Myoma: women with >3 cm uterine myoma 3. Adenomyosis: women with uterus having several dark area (lacunar areas) in one uterine wall or thickening uterine wall Inclusion criteria: 1. >20 years old. 2. Women without myoma or adenomyosis Exclusion Criteria: 1. The patient has a lower urinary tract infection or acute intestinal inflammation. 2. Previous surgery for the bladder or urethra. 3. History of urinary tract stones or tumors.
Gender
Female
Ages
20 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Sheng-Mou Hsiao, MD, +89667000, [email protected]
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT02495311
Organization ID
103129-F
Responsible Party
Principal Investigator
Study Sponsor
Far Eastern Memorial Hospital
Study Sponsor
Sheng-Mou Hsiao, MD, Principal Investigator, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan
Verification Date
February 2022