The Association Between Ovarian Endometrioma and Lower Urinary Tract Symptoms

February 7, 2022 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Recruiting
        • Far-Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with ovarian endometrioma

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 weeks
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
1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2015

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104120-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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