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

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Brief Title

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

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 Type

Observational


Primary Outcome

The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores

Secondary Outcome

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

Condition

Adenomyosis

Intervention

myomectomy or adenomyomectomy

Study Arms / Comparison Groups

 Women with uterine myoma
Description:  Women with uterine myoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

150

Start Date

November 15, 2014

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        

        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

        

        Inclusion criteria:

          1. >20 years old.

          2. Women without myoma or adenomyosis

        

        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.
      

Gender

Female

Ages

20 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sheng-Mou Hsiao, MD, +89667000, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT02495311

Organization ID

103129-F


Responsible Party

Principal Investigator

Study Sponsor

Far Eastern Memorial Hospital


Study Sponsor

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


Verification Date

April 2020