Clinical trial NCT02495311: The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
Official title: The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms and Gastrointestinal Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenomyosis
Uterine Leiomyoma
Keywords: adenomyosis
uterine myoma
lower urinary tract symptoms
sexual dysfunction
gastrointestinal symptom
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with uterine myoma or adenomyosis

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.

Eligibility 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.

Primary outcomes:
measure: The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores
timeFrame: 12 weeks
Secondary outcomes:
measure: The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea
timeFrame: 12 weeks
measure: Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group
timeFrame: 12 weeks
measure: Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
affiliation: Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan
name: Sheng-Mou Hsiao, MD
role: PRINCIPAL_INVESTIGATOR
References: