AdenomyosisNCT02495311
The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
An observational study of Adenomyosis and Uterine Leiomyoma, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to assess the relationship between adenomyosis/myoma and 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
- Adenomyosis, Uterine Leiomyoma
- What is being tested?
- myomectomy or adenomyomectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Nov 2014to 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 uterine myoma or adenomyosis
Who may be able to join
- >20 years old.
- Myoma: women with >3 cm uterine myoma
- Adenomyosis: women with uterus having several dark area (lacunar areas) in one uterine wall or thickening uterine wall
- <The control group>
- >20 years old.
- Women without myoma or adenomyosis
- <Both groups>
Who cannot join
- The patient has a lower urinary tract infection or acute intestinal inflammation.
- Previous surgery for the bladder or urethra.
- 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
Official title: The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms and Gastrointestinal Symptoms
The aim of this study is to assess the relationship between adenomyosis/myoma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms.
Read the detailed description
All outpatient patients were found to have >3 cm uterine myoma or adenomyosis were invited to participate in this study. The size and location of uterine myoma or adenomyosis and the uterus should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete overactive bladder symptom score, female bladder function (UDI-6 \& IIQ-7), female sexual function index, and bowel incontinence assessment questionnaires. In addition, patients who underwent surgeries for myoma or adenomyosis will be requested to complete the above questionnaires at 3 months after surgery. Women with intact uterus should be assessed again by ultrasonography. At least 30 women with age and body mass index matched and without uterine myoma or adenomyosis will be invited to participate in this study as the control group.
- Conditions
- Adenomyosis, Uterine Leiomyoma
- Being tested
- myomectomy or adenomyomectomy
- Keywords
- adenomyosis, uterine myoma, lower urinary tract symptoms, sexual dysfunction, gastrointestinal symptom
- Medical subject headings
- Adenomyosis, Myofibroma, 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.
myomectomy or adenomyomectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Women with uterine myoma | Women with uterine myoma Receives: Procedure: myomectomy or adenomyomectomy | |
| Women with adenomyosis | Women with adenomyosis Receives: Procedure: myomectomy or adenomyomectomy | |
| Women without uterine myoma or adenomyosis | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores
The Spearman's correlation between the size of uterine myoma and the score of Overactive Bladder Symptoms Scores
Measured: 12 weeks
Secondary outcomes (3)
The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea
The Spearman's correlation between the size of uterine myoma and the presence of constipation/diarrhea
Measured: 12 weeks
Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group
Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group by Wilcoxon rank-sum test
Measured: 12 weeks
Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group
Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group by Chi-square test or Fisher's exact test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study start15 Nov 2014
- 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 AdenomyosisStudies 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
- 150 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
- NCT02495311
- Sponsor's protocol ID
- 103129-F
- Status last verified
- Sep 2023
- First submitted
- 4 Jul 2015
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT02495311
- Acronym / sponsor ID
- 103129-F
- Conditions
- Adenomyosis, Uterine Leiomyoma
- Keywords
- adenomyosis, uterine myoma, lower urinary tract symptoms, sexual dysfunction, gastrointestinal symptom
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 15 Nov 2014 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Jul 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.
The aim of this study is to assess the relationship between adenomyosis/myoma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms.
Detailed description
All outpatient patients were found to have >3 cm uterine myoma or adenomyosis were invited to participate in this study. The size and location of uterine myoma or adenomyosis and the uterus should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete overactive bladder symptom score, female bladder function (UDI-6 \& IIQ-7), female sexual function index, and bowel incontinence assessment questionnaires. In addition, patients who underwent surgeries for myoma or adenomyosis will be requested to complete the above questionnaires at 3 months after surgery. Women with intact uterus should be assessed again by ultrasonography. At least 30 women with age and body mass index matched and without uterine myoma or adenomyosis will be invited to participate in this study as the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with uterine myoma | – | Procedure: myomectomy or adenomyomectomyWomen with uterine myoma |
| Women with adenomyosis | – | Procedure: myomectomy or adenomyomectomyWomen with adenomyosis |
| Women without uterine myoma or adenomyosis | – | –Control group |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with uterine myoma or adenomyosis
Key inclusion criteria (7 listed)
- >20 years old.
- Myoma: women with >3 cm uterine myoma
- Adenomyosis: women with uterus having several dark area (lacunar areas) in one uterine wall or thickening uterine wall
- <The control group>
- >20 years old.
Key exclusion criteria (3 listed)
- The patient has a lower urinary tract infection or acute intestinal inflammation.
- Previous surgery for the bladder or urethra.
- 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 |
|---|---|---|
| myomectomy or adenomyomectomy | Procedure or surgery | Women with adenomyosis, Women with uterine myoma |
Primary outcome
The corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores
Time frame: 12 weeks
The Spearman's correlation between the size of uterine myoma and the score of Overactive Bladder Symptoms Scores
3 secondary outcomes
The corrleation coefficient between the size of myoma and the presence of constipation/diarrhea
Time frame: 12 weeks
Comparison of Overactive Bladder Symptoms Scores between the adenomyosis group and the control group
Time frame: 12 weeks
Comparisons of the constipation/diarrhea rates between the adenomyosis group and the control group
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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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 Adenomyosis and Uterine Leiomyoma, 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 7 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 15 Sep 2023. 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 corrleation coefficient between the size of myoma and Overactive Bladder Symptoms Scores (time frame: 12 weeks). 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 15 Sep 2023.