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

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

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

Study Overview

• Status: Recruiting
• Conditions: Adenomyosis; Uterine Leiomyoma
• Intervention / Treatment: Procedure: myomectomy or adenomyomectomy

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
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Sheng-Mou Hsiao, MD; Phone Number: 1818 +89667000; Email: smhsiao2@gmail.com

Study Locations

• Taiwan
  • New Taipei
    • Banqiao, New Taipei, Taiwan, 22050
      • Recruiting
      • Far-Eastern Memorial Hospital
      • Contact: Sheng-Mou Hsiao, M.D.; Phone Number: 1818 +886-2-89667000; Email: smhsiao2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women with uterine myoma or adenomyosis

Description

<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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with uterine myoma	Procedure: myomectomy or adenomyomectomy
Women with adenomyosis	Procedure: myomectomy or adenomyomectomy
Women without uterine myoma or adenomyosis; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Sheng-Mou Hsiao, MD, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2014
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 4, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimated): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: sexual dysfunction; lower urinary tract symptoms; adenomyosis; uterine myoma; gastrointestinal symptom
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Urological Manifestations; Uterine Diseases; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Lower Urinary Tract Symptoms; Adenomyosis; Leiomyoma; Myofibroma
• Other Study ID Numbers: 103129-F