NCT01288703

Brief Summary

The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

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

August 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

January 28, 2011

Last Update Submit

May 27, 2014

Conditions

Urinary Incontinence

Keywords

urinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    To test the feasibility and acceptability of PROMIS and Computerized-Adaptive Testing (CAT) technology in women with Urinary incontinence. In recruiting sixty women, we will conduct pilot-testing on the CAT mode of the PROMIS questionnaires, and compare participant's attitudes about the paper short-forms versus the CAT modes of administration.

    1 day

Eligibility Criteria

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

60 women seeking care for PFDs will be eligible. Women will be excluded if they are unable to read English or have cognitive limitations precluding the completion of PROMIS questionnaires.

You may qualify if:

  • Female
  • Able to read English
  • Diagnosis of urinary incontinence
  • Age 18 or older

You may not qualify if:

  • Unable to read English or cognitive limitations making it difficult for study participants to complete PROMIS questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital Division of Urogynecology

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Sung VW, Marques F, Rogers RR, Williams DA, Myers DL, Clark MA. Content validation of the patient-reported outcomes measurement information system (PROMIS) framework in women with urinary incontinence. Neurourol Urodyn. 2011 Apr;30(4):503-9. doi: 10.1002/nau.21048. Epub 2011 Mar 11.

    PMID: 21400574RESULT

MeSH Terms

Conditions

Urinary Incontinence

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 Symptoms

Study Officials

  • Vivian W Sung, MD, MPH

    Women & Infants Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 2, 2011

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2012

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

US(1)