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

Adenomyosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02495311
• Other study ID #: 103129-F
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenomyosis
• Leiomyoma
• Lower Urinary Tract Symptoms
• Uterine Leiomyoma

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