NCT01616810

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

August 26, 2011

Last Update Submit

February 20, 2019

Conditions

Cystocele

Keywords

urinary tract

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

observation

Healthy participants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with lower urinary tract symptoms and pelvic floor dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dana Soroka, MD, FRCS(C)

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

June 12, 2012

Study Start

January 1, 2007

Primary Completion

October 1, 2007

Study Completion

December 1, 2011

Last Updated

February 22, 2019

Record last verified: 2019-02