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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Urinary Incontinence
Fecal Incontinence
Pelvic Floor Disorders
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014