Voiding DysfunctionDACNCT01154946
Clinical Implication of DAC (Detrusor After-contraction)
An observational study of Voiding Dysfunction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Voiding Dysfunction
- How many people
- 2,309 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Dec 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 2,309 patients more than 18 years old with neurogenic or non-neurogenic voiding dysfunction who performed urodynamic studies
Who may be able to join
- Indications and selection of patients for conduction of urodynamic studies (UDS) were followed as the recommendation of ICS (international continence society).
Who cannot join
- Patients with indwelling catheters, urinary tract infection and urinary stones were excluded from this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: 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
Read the 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.
- Conditions
- Voiding Dysfunction
- Keywords
- detrusor after-contraction, urodynamic, LUTS, urinary bladder, overactive, bladder dysfunction
- Medical subject headings
- Urinary Bladder, Overactive
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 |
|---|---|---|
| DAC group | patients who show detrusor after-contraction during voiding cystometrography (CMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to confirm whether DAC is a true contraction or not
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.
Measured: up to 2 years (2007.Jan-2008.Dec)
Secondary outcomes (1)
Past medical history including neurological disorders and pelvic irradiation were also included in the database
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
Measured: up to 2 years (2007.Jan-2008.Dec)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Seung-June Oh, M.D.,Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154946
- Sponsor's protocol ID
- DAC
- Other IDs
- H-0805-056-245
- Acronym
- DAC
- Status last verified
- Jun 2010
- First submitted
- 29 Jun 2010
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruarte AC, Podesta ML, Medel R. Detrusor after-contractions in children with normal urinary tracts. BJU Int. 2002 Aug;90(3):286-93. doi: 10.1046/j.1464-410x.2002.02827.x.
PubMed 12133067
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Clinical Implication of Detrusor After-contraction (DAC)
- ClinicalTrials.gov ID
- NCT01154946
- Acronym / sponsor ID
- DAC / DAC
- Conditions
- Voiding Dysfunction
- Keywords
- detrusor after-contraction, urodynamic, LUTS, urinary bladder, overactive, bladder dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,309 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Jul 2010 (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 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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAC group | – | –patients who show detrusor after-contraction during voiding cystometrography (CMG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2,309 patients more than 18 years old with neurogenic or non-neurogenic voiding dysfunction who performed urodynamic studies
Key inclusion criteria (1 listed)
- Indications and selection of patients for conduction of urodynamic studies (UDS) were followed as the recommendation of ICS (international continence society).
Key exclusion criteria (1 listed)
- Patients with indwelling catheters, urinary tract infection and urinary stones were excluded from this study
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
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.
1 secondary outcome
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)
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 1 Jul 2010.
- Background: PubMed 12133067Ruarte AC, Podesta ML, Medel R. Detrusor after-contractions in children with normal urinary tracts. BJU Int. 2002 Aug;90(3):286-93. doi: 10.1046/j.1464-410x.2002.02827.x.
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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.
Seung-June Oh, M.D.,Ph.D. principal investigator
Seoul National University Hospital
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 Voiding Dysfunction, run by Seoul National University Hospital 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 1 inclusion and 1 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 1 Jul 2010. 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?
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?
to confirm whether DAC is a true contraction or not (time frame: up to 2 years (2007.Jan-2008.Dec)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154946, which also lists 1 linked publication.
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 1 Jul 2010.