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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02495311
Other study ID # 103129-F
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2014
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Far Eastern Memorial Hospital
Contact Sheng-Mou Hsiao, MD
Phone +89667000
Email smhsiao2@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility <Women with myoma or adenomyosis> 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 <The control group> Inclusion criteria: 1. >20 years old. 2. Women without myoma or adenomyosis <Both groups> 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.

Study Design


Intervention

Procedure:
myomectomy or adenomyomectomy


Locations

Country Name City State
Taiwan Far-Eastern Memorial Hospital Banqiao New Taipei

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores The Spearman's correlation between the size of uterine myoma and the score of Overactive Bladder Symptoms Scores 12 weeks
Secondary The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea The Spearman's correlation between the size of uterine myoma and the presence of constipation/diarrhea 12 weeks
Secondary Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group by Wilcoxon rank-sum test 12 weeks
Secondary Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group by Chi-square test or Fisher's exact test 12 weeks
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