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Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

This study has suspended participant recruitment.
(no budget)
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00870376
First received: March 26, 2009
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  Purpose

Urodynamic study is an objective method to evaluate female patients with lower urinary tract symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to find a simple and objective method to help in evaluating female patients with LUTS. Several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS.


Condition Intervention
Lower Urinary Tract Symptoms
 Other: biomarkers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: April 2009
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
urodynamic studies Other: biomarkers
To define a biomarker or combination of overactive bladder syndrome

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

female patients with LUTS

Criteria

Inclusion Criteria:

  • All female patients (> 20 years) with Lower urinary tract syndrome.

Exclusion Criteria:

  • Female patients with tumor and stone were excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870376

Locations
Taiwan
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banciao, Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Research Ethics Review Committee, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00870376     History of Changes
Other Study ID Numbers: 97109
Study First Received: March 26, 2009
Last Updated: January 5, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:
lower urinary tract symptoms
biomarkers
urodynamic studies

ClinicalTrials.gov processed this record on May 22, 2013