Ovarian EndometriomaNCT02623244
The Association Between Ovarian Endometrioma and Lower Urinary Tract Symptoms
An observational study of Ovarian Endometrioma, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- Laparoscopic oophorocystectomy or oophorectomy
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Nov 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with ovarian endometrioma
Who may be able to join
- >20 years old.
- Ovarian endometrioma: women having a frosted glass content in ovarian cyst
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
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.
Read the 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.
- Conditions
- Ovarian Endometrioma
- Being tested
- Laparoscopic oophorocystectomy or oophorectomy
- Keywords
- ovarian endometrioma, lower urinary tract symptoms, sexual dysfunction, gastrointestinal symptoms
- Medical subject headings
- Endometriosis, Lower Urinary Tract Symptoms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic oophorocystectomy or oophorectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ovarian endometrioma | Women with ovarian endometrioma noted by ultrasonography. Receives: Procedure: Laparoscopic oophorocystectomy or oophorectomy | |
| The control group | Women with age and body mass index matched and without ovarian endometrioma in ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association of ovarian endometrioma and overactive bladder symptoms score
The Spearman correlation between the presence of ovarian endometrioma and overactive bladder symptoms score
Measured: 1 week
Secondary outcomes (2)
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
Measured: 1 weeks
The association between ovarian endometrioma and bowel incontinence assessment score
The Spearman correlation between the presence of ovarian endometrioma and bowel incontinence assessment score
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start15 Nov 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian EndometriomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
- Investigators
- Sheng-Mou Hsiao, MD, Principal investigator, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623244
- Sponsor's protocol ID
- 104120-F
- Status last verified
- Feb 2022
- First submitted
- 3 Dec 2015
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Ovarian Endometrioma and Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT02623244
- Acronym / sponsor ID
- 104120-F
- Conditions
- Ovarian Endometrioma
- Keywords
- ovarian endometrioma, lower urinary tract symptoms, sexual dysfunction, gastrointestinal symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ovarian endometrioma | – | Procedure: Laparoscopic oophorocystectomy or oophorectomyWomen with ovarian endometrioma noted by ultrasonography. |
| The control group | – | –Women with age and body mass index matched and without ovarian endometrioma in ultrasonography |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with ovarian endometrioma
Key inclusion criteria (2 listed)
- >20 years old.
- Ovarian endometrioma: women having a frosted glass content in ovarian cyst
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic oophorocystectomy or oophorectomy | Procedure or surgery | ovarian endometrioma |
Primary outcome
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
2 secondary outcomes
The association between ovarian endometrioma and female sexual function index score
Time frame: 1 weeks
The association between ovarian endometrioma and bowel incontinence assessment score
Time frame: 1 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Mou Hsiao, MD principal investigator
Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Endometrioma, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Mou Hsiao, MD (+89667000 ext. 1818, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association of ovarian endometrioma and overactive bladder symptoms score (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.