NCT00870376

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2009

Completed
Last Updated

February 10, 2017

Status Verified

July 1, 2015

Enrollment Period

Same day

First QC Date

March 26, 2009

Last Update Submit

February 9, 2017

Conditions

Lower Urinary Tract Symptoms

Keywords

lower urinary tract symptomsbiomarkersurodynamic studies

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Study Arms (1)

urodynamic studies

Other: biomarkers

Interventions

biomarkersOTHER

To define a biomarker or combination of overactive bladder syndrome

urodynamic studies

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female patients with LUTS

You may qualify if:

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

You may not qualify if:

  • Female patients with tumor and stone were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banciao, Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 23, 2009

Last Updated

February 10, 2017

Record last verified: 2015-07

Locations

TW(1)