- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01154946
Clinical Implication of DAC (Detrusor After-contraction) (DAC)
June 30, 2010 updated by: Seoul National University Hospital
A New Approach to Clinical Implication of Detrusor After-contraction (DAC)
The aims of this study are
- to confirm whether detrusor after-contraction (DAC) is a true contraction or not with a new approach
- and to understand clinical implication of DAC
Study Overview
Status
Completed
Conditions
Detailed Description
The definition of detrusor after-contraction (DAC) is usually accepted as the increase of detrusor pressure (Pdet), whether it is sudden or not, after cessation of urinary flow.
The amount of increase in Pdet is sometimes included in the definition of DAC (14, 15, 20 cmH2O or at least two times the level of the maximal Pdet during the voiding phase).
However, it is clear that the lack of a well-established definition may induce much bias in the interpretation of the clinical implication of DAC.
The previous studies showed a wide range of prevalence.1-4
DAC seemed to occur more frequently in children and the occurrence rate usually decreased with age in urodynamic studies.
Study Type
Observational
Enrollment (Actual)
2309
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
2,309 patients more than 18 years old with neurogenic or non-neurogenic voiding dysfunction who performed urodynamic studies
Description
Inclusion Criteria:
- Indications and selection of patients for conduction of urodynamic studies (UDS) were followed as the recommendation of ICS (international continence society).
Exclusion Criteria:
- Patients with indwelling catheters, urinary tract infection and urinary stones were excluded from this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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DAC group
patients who show detrusor after-contraction during voiding cystometrography (CMG)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
to confirm whether DAC is a true contraction or not
Time Frame: up to 2 years (2007.Jan-2008.Dec)
|
no change of Pdet when patients cough could confirm that DAC was a true contraction.
Because an artifact occurred when a catheter was pressed against bladder wall or urethra, no change of intravesical pressure and increase of abdominal pressure finally induced a negative deflection of Pdet and this change of Pdet could be regarded as an artifact.
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up to 2 years (2007.Jan-2008.Dec)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Past medical history including neurological disorders and pelvic irradiation were also included in the database
Time Frame: up to 2 years (2007.Jan-2008.Dec)
|
One-way analysis of variance and the chi-square test were performed to determine whether there was a relationship between the presence of DAC and the underlying neurogenic and non-neurogenic conditions
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up to 2 years (2007.Jan-2008.Dec)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seung-June Oh, M.D.,Ph.D., Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
June 29, 2010
First Submitted That Met QC Criteria
June 30, 2010
First Posted (Estimate)
July 1, 2010
Study Record Updates
Last Update Posted (Estimate)
July 1, 2010
Last Update Submitted That Met QC Criteria
June 30, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- DAC
- H-0805-056-245
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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