NCT01479816

Brief Summary

This study will analyse existing data to establish a clinically useful index to predict those women who are more likely to become incontinent. This would create significant opportunities for focused prevention and early intervention strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
702

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

4 years

First QC Date

November 22, 2011

Last Update Submit

July 19, 2016

Conditions

Urinary Incontinence

Keywords

continenceindex

Outcome Measures

Primary Outcomes (1)

  • Index Estimation for Urinary Incontinence Prediction

    Several risk factors identified can serve as an index in predicting the development of urinary incontinence in elderly women.

    2 years

Secondary Outcomes (1)

  • Predictive Reliability of Urinary Incontinence Index and its Validation

    3 years

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women 55 years and older

You may qualify if:

  • Women

You may not qualify if:

  • Men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oakland University

Rochester, Michigan, 48309, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceErythema Multiforme

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsErythemaSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vesiculobullous

Study Officials

  • Ananias Diokno, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 24, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

July 21, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)