Urinary IncontinenceNCT02145806
Validation of Korean Version of ICIQ-SF
An observational study of Urinary Incontinence, run by The Catholic University of Korea.
Trial summary
1. Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women 2. Evaluation the effect of urinary incontinence in pregnant and postpartum women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Sep 2014
- How long will I take part?
- 1 Week
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 130
Who may be able to join
- Being pregnant or postpartum ≤ 3 weeks
- Able to read and understand Korean
- At least 18 years of age
Who cannot join
- Refuse to participate in the study
- Pelvic inflammatory disease
- Psychiatric disease
- Needed to be treated in the 7 days
About this study
- Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women
- Evaluation the effect of urinary incontinence in pregnant and postpartum women.
- Conditions
- Urinary Incontinence
- Keywords
- Urinary incontinence, Validation study, Pregnant women, Postpartum period
- Medical subject headings
- Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Cross-sectional
- Enrolment
- 134 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea
- Responsible party
- Principal investigator, Yeon Hee Kim, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145806
- Sponsor's protocol ID
- CMC_UI_2014
- Status last verified
- Feb 2015
- First submitted
- 21 May 2014
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Korean Version of ICIQ-SF
- ClinicalTrials.gov ID
- NCT02145806
- Acronym / sponsor ID
- CMC_UI_2014
- Conditions
- Urinary Incontinence
- Keywords
- Urinary incontinence, Validation study, Pregnant women, Postpartum period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 May 2014 (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.
- Validation of the Korean version of the ICIQ-UI SF for pregnant and postpartum women
- Evaluation the effect of urinary incontinence in pregnant and postpartum women.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 130
Key inclusion criteria (3 listed)
- Being pregnant or postpartum ≤ 3 weeks
- Able to read and understand Korean
- At least 18 years of age
Key exclusion criteria (4 listed)
- Refuse to participate in the study
- Pelvic inflammatory disease
- Psychiatric disease
- Needed to be treated in the 7 days
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
Urinary incontinence
Time frame: 1-2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by The Catholic University of 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary incontinence (time frame: 1-2 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 13 Feb 2015.