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Improving Women's Health by Using an Electronic Pelvic Floor Questionnaire

Primary Purpose

Urinary Incontinence, Fecal Incontinence, Pelvic Floor Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-PAQ-PF
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Urinary Incontinence focused on measuring urinary incontinence, fecal incontinence, communication

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Woman
  • Aged 40 and older
  • Scheduled for a well visit at the Women's Health Internal Medicine West Clinic

Exclusion Criteria:

  • Unable to speak English
  • Unable to fill out questionnaire
  • Excluded by patient's clinician prior to recruitment

Sites / Locations

  • UW Health Women's Health Internal Medicine West

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

pre-visit e-PAQ-PF

post-visit e-PAQ-PF

Arm Description

Participants assigned to fill out the e-PAQ-PF prior to their clinic visit. Participants will arrive early to clinic appointment and fill out e-PAQ-PF. Results will be given to clinician and participant. After their visit they will complete the post visit questionnaire.

Participants assigned to complete the e-PAQ-PF after their clinic visit. Pre-visit participants will sign consent form - but otherwise will receive no study interventions. Post-visit they will fill out e-PAQ-PF and post visit questionnaire.

Outcomes

Primary Outcome Measures

Mention of urinary incontinence in the clinic visit note

Secondary Outcome Measures

Mention of fecal incontinence in the clinic visit note
Participant report of urinary discussion
Participant report of fecal incontinence discussion
MD/NP initiated urinary incontinence discussion (per participant report)
MD/NP initiate discussion of Fecal incontinence per participant report
Urinary Incontinence History Score (Assessed from Clinic Note)
Fecal Incontinence History Score (Assessed from Clinic Note)
Urinary Incontinence Assessment and Treatment Score (from Clinic Note)
Fecal Incontinence Assessment & Treatment Score (from Clinic Note)
Any Urinary Incontinence Treatment or Referral (per clinic note)
Any treatment or referral for fecal incontinence? (per clinic note)
Diagnostic code given - Urinary incontinence
Diagnostic code given - fecal incontinence
Urinary incontinence detected
fecal incontinence detected

Full Information

First Posted
April 13, 2009
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
Sigma Xi Society, Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00880880
Brief Title
Improving Women's Health by Using an Electronic Pelvic Floor Questionnaire
Official Title
Improving the Assessment of Women's Health Through the Use of a Computerized Pelvic Floor Questionnaire
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Sigma Xi Society, Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall goal of this study is to test whether an electronic pelvic floor questionnaire (e-PAQ-PF) will increase discussion rates of incontinence in a primary care setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Fecal Incontinence, Pelvic Floor Disorders
Keywords
urinary incontinence, fecal incontinence, communication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pre-visit e-PAQ-PF
Arm Type
Experimental
Arm Description
Participants assigned to fill out the e-PAQ-PF prior to their clinic visit. Participants will arrive early to clinic appointment and fill out e-PAQ-PF. Results will be given to clinician and participant. After their visit they will complete the post visit questionnaire.
Arm Title
post-visit e-PAQ-PF
Arm Type
No Intervention
Arm Description
Participants assigned to complete the e-PAQ-PF after their clinic visit. Pre-visit participants will sign consent form - but otherwise will receive no study interventions. Post-visit they will fill out e-PAQ-PF and post visit questionnaire.
Intervention Type
Other
Intervention Name(s)
e-PAQ-PF
Other Intervention Name(s)
electronic personal assessment questionnaire - pelvic floor, electronic pelvic floor questionnaire
Intervention Description
Participants will fill out the e-PAQ-PF prior to their clinic visit. The e-PAQ-PF has 4 dimensions (urinary, bowel, vaginal, sexual) and asks about symptoms severity, bother of symptoms, and impact on quality of life. A copy of the results will be given to their clinician and the participant.
Primary Outcome Measure Information:
Title
Mention of urinary incontinence in the clinic visit note
Secondary Outcome Measure Information:
Title
Mention of fecal incontinence in the clinic visit note
Title
Participant report of urinary discussion
Time Frame
same day (within one week of appointment)
Title
Participant report of fecal incontinence discussion
Time Frame
same day (within one week of appointment)
Title
MD/NP initiated urinary incontinence discussion (per participant report)
Title
MD/NP initiate discussion of Fecal incontinence per participant report
Title
Urinary Incontinence History Score (Assessed from Clinic Note)
Title
Fecal Incontinence History Score (Assessed from Clinic Note)
Title
Urinary Incontinence Assessment and Treatment Score (from Clinic Note)
Title
Fecal Incontinence Assessment & Treatment Score (from Clinic Note)
Title
Any Urinary Incontinence Treatment or Referral (per clinic note)
Title
Any treatment or referral for fecal incontinence? (per clinic note)
Title
Diagnostic code given - Urinary incontinence
Title
Diagnostic code given - fecal incontinence
Title
Urinary incontinence detected
Time Frame
clinic visit
Title
fecal incontinence detected
Time Frame
clinic visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Woman Aged 40 and older Scheduled for a well visit at the Women's Health Internal Medicine West Clinic Exclusion Criteria: Unable to speak English Unable to fill out questionnaire Excluded by patient's clinician prior to recruitment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris M Schussler-Fiorenza, MD
Organizational Affiliation
University of Wisconsin School of Medicine & Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald E Gangnon, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arnold Wald, MD
Organizational Affiliation
University of Wisconsin School of Medicine & Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Health Women's Health Internal Medicine West
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26555779
Citation
Schussler-Fiorenza Rose SM, Gangnon RE, Chewning B, Wald A. Increasing Discussion Rates of Incontinence in Primary Care: A Randomized Controlled Trial. J Womens Health (Larchmt). 2015 Nov;24(11):940-9. doi: 10.1089/jwh.2015.5230.
Results Reference
derived

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Improving Women's Health by Using an Electronic Pelvic Floor Questionnaire

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