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

Recruiting

• Conditions: Uterine Leiomyoma; Adenomyosis
• Interventions: Procedure: myomectomy or adenomyomectomy

• Registration Number: NCT02495311
• Lead Sponsor: Far Eastern Memorial Hospital

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 Timeline

• Study Start: 2014-11-15
• Study First Submitted: 2015-07-04
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with uterine myoma	myomectomy or adenomyomectomy	Women with uterine myoma
Women with adenomyosis	myomectomy or adenomyomectomy	Women with adenomyosis

Primary Outcome Measures

Name	Time	Method
The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores	12 weeks	The Spearman's correlation between the size of uterine myoma and the score of Overactive Bladder Symptoms Scores

Secondary Outcome Measures

Name	Time	Method
The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea	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	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	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

Trial Locations

Locations (1)

Far-Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan