Studies of Biomarkers in Female Lower Urinary Tract Symptoms | NCT01681784

Studies
Studies of Biomarkers in Female Lower Urinary Tract Symptoms

NCT01681784

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 10, 2012Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Disorder of the Lower Urinary Tract

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Sep 5, 2012

First Submission Date that Met QC Criteria

Sep 7, 2012

First Posted Date

Sep 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2012

Last Update Posted Date

Sep 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Hospital, Professor Ho-Hsiung Lin, National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations in diagnosing different urodynamic diagnoses.

Detailed Description

Abstract

Background/Purpose:

Urodyamic 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.

Patients and Methods:

We will perform a prospective study to recruit 300 female patients with LUTS at the outpatient clinic of Department of Obstetrics and Gynecology of National Taiwan University Hospital and Far Eastern Memorial Hospital.

All patients will be asked to complete OABSS, UDI-6 & IIQ-7 questionnaires, voiding diary, 20-min pad test and urodynamic studies. Urinary nerve growth factor, prostaglandin E2, interleukin-6 and epidermal growth factor were also measured. Besides, we will also recruit 30 female patients without LUTS in our outpatient clinic, and they will be asked to complete the above questionnaire and examinations except pad test and urodynamic studies.

Possible Results:

With the comparison of the above parameters between non-LUTS and LUTS patients, we can answer the questions that (1) the mean values of urinary NGF, PGE2, IL-6, EGF in different urodynamic studies, (2) the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations in diagnosing different urodynamic diagnoses.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients with lower urinary tract symptoms

Exclusion Criteria:

acute cystitis

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female patients with lower urinary tract symptoms and underwent urodynamic studies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ho-Hsiung Lin, MD, PhD	Contact	+88623123456	71557	hhlin@ntuh.gov.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei	Taipei	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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