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

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ClinicalTrials.gov Identifier: NCT02495311
Recruitment Status : Recruiting
First Posted : July 13, 2015
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital

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.

Condition or disease Intervention/treatment
Adenomyosis Uterine Leiomyoma 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms and Gastrointestinal Symptoms
Actual Study Start Date : November 15, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores [ Time Frame: 12 weeks ]
    The Spearman's correlation between the size of uterine myoma and the score of Overactive Bladder Symptoms Scores


Secondary Outcome Measures :
  1. The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea [ Time Frame: 12 weeks ]
    The Spearman's correlation between the size of uterine myoma and the presence of constipation/diarrhea

  2. Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group [ Time Frame: 12 weeks ]
    Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group by Wilcoxon rank-sum test

  3. Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group [ Time Frame: 12 weeks ]
    Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group by Chi-square test or Fisher's exact test



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with uterine myoma or adenomyosis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495311


Contacts
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Contact: Sheng-Mou Hsiao, MD +89667000 ext 1818 smhsiao2@gmail.com

Locations
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Taiwan
Far-Eastern Memorial Hospital Recruiting
Banqiao, New Taipei, Taiwan, 22050
Contact: Sheng-Mou Hsiao, M.D.    +886-2-89667000 ext 1818    smhsiao2@gmail.com   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
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Principal Investigator: Sheng-Mou Hsiao, MD Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

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Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02495311     History of Changes
Other Study ID Numbers: 103129-F
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

Keywords provided by Sheng-Mou Hsiao, Far Eastern Memorial Hospital:
adenomyosis
uterine myoma
lower urinary tract symptoms
sexual dysfunction
gastrointestinal symptom

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Leiomyoma
Myofibroma
Adenomyosis
Urological Manifestations
Signs and Symptoms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female