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
  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:


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
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: 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

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014