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

This study has been completed.
Sponsor:
Collaborators:
Sigma Xi Society
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00880880
First received: April 13, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Urinary Incontinence
Fecal Incontinence
Pelvic Floor Disorders
Other: e-PAQ-PF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving the Assessment of Women's Health Through the Use of a Computerized Pelvic Floor Questionnaire

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Mention of urinary incontinence in the clinic visit note [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mention of fecal incontinence in the clinic visit note [ Designated as safety issue: No ]
  • Participant report of urinary discussion [ Time Frame: same day (within one week of appointment) ] [ Designated as safety issue: No ]
  • Participant report of fecal incontinence discussion [ Time Frame: same day (within one week of appointment) ] [ Designated as safety issue: No ]
  • MD/NP initiated urinary incontinence discussion (per participant report) [ Designated as safety issue: No ]
  • MD/NP initiate discussion of Fecal incontinence per participant report [ Designated as safety issue: No ]
  • Urinary Incontinence History Score (Assessed from Clinic Note) [ Designated as safety issue: No ]
  • Fecal Incontinence History Score (Assessed from Clinic Note) [ Designated as safety issue: No ]
  • Urinary Incontinence Assessment and Treatment Score (from Clinic Note) [ Designated as safety issue: No ]
  • Fecal Incontinence Assessment & Treatment Score (from Clinic Note) [ Designated as safety issue: No ]
  • Any Urinary Incontinence Treatment or Referral (per clinic note) [ Designated as safety issue: No ]
  • Any treatment or referral for fecal incontinence? (per clinic note) [ Designated as safety issue: No ]
  • Diagnostic code given - Urinary incontinence [ Designated as safety issue: No ]
  • Diagnostic code given - fecal incontinence [ Designated as safety issue: No ]
  • Urinary incontinence detected [ Time Frame: clinic visit ] [ Designated as safety issue: No ]
  • fecal incontinence detected [ Time Frame: clinic visit ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: August 2007
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pre-visit e-PAQ-PF
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.
Other: e-PAQ-PF
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.
Other Names:
  • electronic personal assessment questionnaire - pelvic floor
  • electronic pelvic floor questionnaire
No Intervention: post-visit e-PAQ-PF
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880880

Locations
United States, Wisconsin
UW Health Women's Health Internal Medicine West
Madison, Wisconsin, United States, 53717
Sponsors and Collaborators
University of Wisconsin, Madison
Sigma Xi Society
Investigators
Principal Investigator: Chris M Schussler-Fiorenza, MD University of Wisconsin School of Medicine & Public Health
Study Chair: Ronald E Gangnon, PhD University of Wisconsin, Madison
Principal Investigator: Arnold Wald, MD University of Wisconsin School of Medicine & Public Health
  More Information

No publications provided

Responsible Party: Chris M Schussler-Fiorenza / Ronald Gangnon (Advisor), University of Wisconsin - Madison
ClinicalTrials.gov Identifier: NCT00880880     History of Changes
Other Study ID Numbers: HS17028, 1 R36 HS017028-01A1
Study First Received: April 13, 2009
Last Updated: April 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
urinary incontinence
fecal incontinence
communication

Additional relevant MeSH terms:
Fecal Incontinence
Urinary Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014