Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Implication of DAC (Detrusor After-contraction)

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01154946
First received: June 29, 2010
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

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

Condition
Voiding Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A New Approach to Clinical Implication of Detrusor After-contraction (DAC)

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • to confirm whether DAC is a true contraction or not [ Time Frame: up to 2 years (2007.Jan-2008.Dec) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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


Enrollment: 2309
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
DAC group
patients who show detrusor after-contraction during voiding cystometrography (CMG)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154946

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Seung-June Oh, M.D.,Ph.D. Seoul National University Hospital
  More Information

Publications:
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01154946     History of Changes
Other Study ID Numbers: DAC, H-0805-056-245
Study First Received: June 29, 2010
Last Updated: June 30, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
detrusor after-contraction
urodynamic
LUTS
urinary bladder, overactive
bladder dysfunction

ClinicalTrials.gov processed this record on November 20, 2014