Lower Urinary Tract Symptoms Screening Questionnaire | NCT01616810

Studies
Lower Urinary Tract Symptoms Screening Questionnaire

NCT01616810

Sponsor

Unity Health Toronto

Status

Completed

Last Update Posted

Feb 22, 2019Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Cystocele

Interventions

Not provided

Countries

Not provided

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 26, 2011

First Submission Date that Met QC Criteria

Jun 8, 2012

First Posted Date

Jun 12, 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

Feb 20, 2019

Last Update Posted Date

Feb 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to determine the validity of a screening tool which has been designed to detect the presence or absence of lower urinary tract symptoms in the general female population.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

300Actual

Label	Type	Description	Intervention Names
observation		Healthy participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence or absence of lower urinary tract symptoms in the general female population	To validate the effectiveness of a screening tool in detecting the presence or absence of lower urinary tract symptoms in the general female population.	Five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy participants, 18 years of age and older with any gynecological symptoms

Exclusion Criteria:

Patients with lower urinary tract symptoms and pelvic floor dysfunction

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy participants, 18 years of age and older with any gynecological symptoms other than lower urinary tract symptoms or pelvic floor dysfunction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dana Soroka, MD, FRCS(C)	Unity Health Toronto	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D052858	Cystocele

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided