Improving Women's Health by Using an Electronic Pelvic Floor Questionnaire - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison Sigma Xi Society Agency for Healthcare Research and Quality (AHRQ)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00880880

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

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence Women's Health

U.S. FDA Resources

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

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
pre-visit e-PAQ-PF: Experimental 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.
post-visit e-PAQ-PF: No Intervention 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

Agency for Healthcare Research and Quality (AHRQ)

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

Keywords provided by University of Wisconsin, Madison:

urinary incontinence
fecal incontinence
communication

Study placed in the following topic categories:

Signs and Symptoms
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Urination Disorders

Gastrointestinal Diseases
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Fecal Incontinence
Digestive System Diseases
Urologic Diseases

Urination Disorders
Gastrointestinal Diseases
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 07, 2009