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Clinical Implication of DAC (Detrusor After-contraction) (DAC)

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ClinicalTrials.gov Identifier: NCT01154946
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

Tracking Information
First Submitted Date June 29, 2010
First Posted Date July 1, 2010
Last Update Posted Date July 1, 2010
Study Start Date January 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2010)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 30, 2010)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Implication of DAC (Detrusor After-contraction)
Official Title A New Approach to Clinical Implication of Detrusor After-contraction (DAC)
Brief 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
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
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Voiding Dysfunction
Intervention Not Provided
Study Groups/Cohorts DAC group
patients who show detrusor after-contraction during voiding cystometrography (CMG)
Publications * Ruarte AC, Podestá ML, Medel R. Detrusor after-contractions in children with normal urinary tracts. BJU Int. 2002 Aug;90(3):286-93.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 30, 2010)
2309
Original Actual Enrollment Same as current
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01154946
Other Study ID Numbers DAC
H-0805-056-245
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Seung-June Oh, M.D.,Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date June 2010