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

F

Far Eastern Memorial Hospital

Status

Enrolling

Conditions

Uterine Leiomyoma
Adenomyosis

Treatments

Procedure: myomectomy or adenomyomectomy

Study type

Observational

Funder types

Other

Identifiers

NCT02495311
103129-F

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

<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.

Trial design

150 participants in 3 patient groups

Women with uterine myoma
Description:
Women with uterine myoma
Treatment:
Procedure: myomectomy or adenomyomectomy
Women with adenomyosis
Description:
Women with adenomyosis
Treatment:
Procedure: myomectomy or adenomyomectomy
Women without uterine myoma or adenomyosis
Description:
Control group

Trial contacts and locations

1

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Central trial contact

Sheng-Mou Hsiao, MD

Data sourced from clinicaltrials.gov

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