The Association Between Ovarian Endometrioma and Lower Urinary Tract Symptoms

Ovarian Endometrioma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02623244
• Other study ID #: 104120-F
• Status: Recruiting
• Start date: November 15, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Far Eastern Memorial Hospital
• Contact: Sheng-Mou Hsiao, MD
• Phone: +89667000
• Email: smhsiao2[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Lower Urinary Tract Symptoms
• Ovarian Endometrioma

Intervention

Procedure:
• Laparoscopic oophorocystectomy or oophorectomy

Locations

Country	Name	City	State
Taiwan	Far-Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association of ovarian endometrioma and overactive bladder symptoms score	The Spearman correlation between the presence of ovarian endometrioma and overactive bladder symptoms score	1 week
Secondary	The association between ovarian endometrioma and female sexual function index score	The Spearman correlation between the presence of ovarian endometrioma and female sexual function index score	1 weeks
Secondary	The association between ovarian endometrioma and bowel incontinence assessment score	The Spearman correlation between the presence of ovarian endometrioma and bowel incontinence assessment score	1 weeks