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The Association Between Ovarian Endometrioma and Lower Urinary Tract Symptoms

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ClinicalTrials.gov Identifier: NCT02623244
Recruitment Status : Recruiting
First Posted : December 7, 2015
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Brief Summary:
To assess the relationship between ovarian endometrioma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms. In addition, the investigators also assess the impact of surgeries for ovarian endometrioma on lower urinary tract symptoms, sexual function and gastrointestinal symptoms.

Condition or disease Intervention/treatment
Ovarian Endometrioma Procedure: Laparoscopic oophorocystectomy or oophorectomy

Detailed Description:
All patients were found to have ovarian endometrioma were invited to participate in this study. The size and location of ovarian endometrioma should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete overactive bladder symptom score, female bladder function, female sexual function, and bowel incontinence assessment questionnaires and CA125 level. In addition, patients who underwent surgeries for ovarian endometrioma will be requested to complete the above questionnaires and CA125 check-up at 3 & 6 months after surgery. At least 30 women with age and body mass index matched and without ovarian endometrioma will be invited to participate in this study as the control group.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : November 6, 2015
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ovarian endometrioma
Women with ovarian endometrioma noted by ultrasonography.
Procedure: Laparoscopic oophorocystectomy or oophorectomy
The control group
Women with age and body mass index matched and without ovarian endometrioma in ultrasonography



Primary Outcome Measures :
  1. The association of ovarian endometrioma and overactive bladder symptoms score [ Time Frame: 1 week ]
    The Spearman correlation between the presence of ovarian endometrioma and overactive bladder symptoms score


Secondary Outcome Measures :
  1. The association between ovarian endometrioma and female sexual function index score [ Time Frame: 1 weeks ]
    The Spearman correlation between the presence of ovarian endometrioma and female sexual function index score

  2. The association between ovarian endometrioma and bowel incontinence assessment score [ Time Frame: 1 weeks ]
    The Spearman correlation between the presence of ovarian endometrioma and bowel incontinence assessment score



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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 ovarian endometrioma
Criteria

Inclusion Criteria:

  1. >20 years old.
  2. Ovarian endometrioma: women having a frosted glass content in ovarian cyst

Exclusion Criteria:

  1. The patient is acute lower urinary tract infection or intestinal inflammation.
  2. Had received surgery bladder or urethra.
  3. Patients with a 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): NCT02623244


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 Ob/Gyn, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02623244     History of Changes
Other Study ID Numbers: 104120-F
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

Keywords provided by Sheng-Mou Hsiao, Far Eastern Memorial Hospital:
ovarian endometrioma
lower urinary tract symptoms
sexual dysfunction
gastrointestinal symptoms

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Endometriosis
Urological Manifestations
Signs and Symptoms
Genital Diseases, Female