NCT02623244

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

9.1 years

First QC Date

December 3, 2015

Last Update Submit

February 7, 2022

Conditions

Ovarian Endometrioma

Keywords

ovarian endometriomalower urinary tract symptomssexual dysfunctiongastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The association between ovarian endometrioma and female sexual function index score

    1 weeks

  • The association between ovarian endometrioma and bowel incontinence assessment score

    1 weeks

Study Arms (2)

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

Interventions

Laparoscopic oophorocystectomy or oophorectomyPROCEDURE
ovarian endometrioma

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with ovarian endometrioma

You may qualify if:

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

You may not qualify if:

  • The patient is acute lower urinary tract infection or intestinal inflammation.
  • Had received surgery bladder or urethra.
  • Patients with a history of urinary tract stones or tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Conditions

EndometriosisLower Urinary Tract SymptomsSexual Dysfunction, Physiological

Interventions

Ovariectomy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CastrationEndocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical ProceduresGynecologic Surgical Procedures

Study Officials

  • Sheng-Mou Hsiao, MD

    Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+89667000smhsiao2@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Ob/Gyn

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 7, 2015

Study Start

November 15, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

TW(1)