Benign Uterine DiseaseNCT01683890
Study on Bladder and Sexual Function Change After Simple Hysterectomy
An observational study of Benign Uterine Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring after simple hysterectomy and to analyze the influence of bladder symptoms and sexual function change on quality of life of patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Benign Uterine Disease
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Jul 2017
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patinets who undergo simple hysterectomy due to benign uterine disease at university hospital
Who may be able to join
- Patients who is planed to undergo simple hysterectomy due to benign uterine disease
- Uterine leiomyoma
- Uterine adenomyosis
- Endometrial hyperplasia
- Cervical intraepithelial neoplasia (including carcinoma in situ, FIGO stage IA1 cancer)
- Dysfunctional uterine bleeding
- Other benign uterine disease requiring hysterectomy
Who cannot join
- Patients who are taking medication for overactive bladder
- Patients who underwent incontinence surgery due to urinary incontinence
- Acute or chronic infectious disease of urinary tract
- Neurologic disease causing urinary abnormality
- Previous pelvic radiation therapy
- Patients who are undergoing incontinence surgery with hysterectomy
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
Official title: Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy
To evaluate the incidence and pattern of bladder symptoms and sexual function change occuring after simple hysterectomy and to analyze the influence of bladder symptoms and sexual function change on quality of life of patients.
- Conditions
- Benign Uterine Disease
- Keywords
- Bladder symptoms, Sexual function, Quality of life, Simple hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Simple hysterectomy group | Patients will undergo simple hysterectomy due to benign uterine disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bladder symptoms
Measured: within 6 months after surgery
Secondary outcomes (3)
Pattern change of bladder symptoms after surgery
Measured: Baseline and within 6 months after surgery
Sexual function change
Measured: Baseline and within 6 months after surgery
Quality of life
Measured: within 6 months aftr surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Uterine DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Hee-Dong Chae, Asan Medical Center
- Investigators
- Hee-Dong Chae, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683890
- Sponsor's protocol ID
- SBSFSH
- Status last verified
- May 2017
- First submitted
- 4 Sep 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Pattern of Overactive Bladder Symptoms Occurring After Hysterectomy
- ClinicalTrials.gov ID
- NCT01683890
- Acronym / sponsor ID
- SBSFSH
- Conditions
- Benign Uterine Disease
- Keywords
- Bladder symptoms, Sexual function, Quality of life, Simple hysterectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Sep 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 12 Sep 2012 (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 evaluate the incidence and pattern of bladder symptoms and sexual function change occuring after simple hysterectomy and to analyze the influence of bladder symptoms and sexual function change on quality of life of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simple hysterectomy group | – | –Patients will undergo simple hysterectomy due to benign uterine disease. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patinets who undergo simple hysterectomy due to benign uterine disease at university hospital
Key inclusion criteria (7 listed)
- Patients who is planed to undergo simple hysterectomy due to benign uterine disease
Key exclusion criteria (7 listed)
- Patients who are taking medication for overactive bladder
- Patients who underwent incontinence surgery due to urinary incontinence
- Acute or chronic infectious disease of urinary tract
- Neurologic disease causing urinary abnormality
- Previous pelvic radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of bladder symptoms
Time frame: within 6 months after surgery
3 secondary outcomes
Pattern change of bladder symptoms after surgery
Time frame: Baseline and within 6 months after surgery
Sexual function change
Time frame: Baseline and within 6 months after surgery
Quality of life
Time frame: within 6 months aftr surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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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.
Hee-Dong Chae, M.D., Ph.D. principal investigator
Asan Medical Center
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 Benign Uterine Disease, run by Asan Medical Center at 1 site in South Korea.
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 7 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 31 May 2017. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bladder symptoms (time frame: within 6 months after surgery). 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 31 May 2017.