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

NCT ID: NCT02495311

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-15

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Adenomyosis Uterine Leiomyoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with uterine myoma

Women with uterine myoma

myomectomy or adenomyomectomy

Intervention Type PROCEDURE

Women with adenomyosis

Women with adenomyosis

myomectomy or adenomyomectomy

Intervention Type PROCEDURE

Women without uterine myoma or adenomyosis

Control group

No interventions assigned to this group

Interventions

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myomectomy or adenomyomectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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\>


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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheng-Mou Hsiao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

Locations

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Far-Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Mou Hsiao, MD

Role: CONTACT

+89667000 ext. 1818

Facility Contacts

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Sheng-Mou Hsiao, M.D.

Role: primary

+886-2-89667000 ext. 1818

Other Identifiers

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103129-F

Identifier Type: -

Identifier Source: org_study_id

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