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

Urinary Incontinence Clinical Trial

Official title:

Improving the Assessment of Women's Health Through the Use of a Computerized Pelvic Floor Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880880
• Other study ID #: HS17028
• Secondary ID: 1R36HS017028-01A
• Status: Completed
• Phase: N/A
• First received: April 13, 2009
• Last updated: October 1, 2015
• Start date: August 2007

Study information

• Verified date: April 2009
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fecal Incontinence
• Pelvic Floor Disorders
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
United States	UW Health Women's Health Internal Medicine West	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Agency for Healthcare Research and Quality (AHRQ), Sigma Xi Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mention of urinary incontinence in the clinic visit note			No
Secondary	Mention of fecal incontinence in the clinic visit note			No
Secondary	Participant report of urinary discussion		same day (within one week of appointment)	No
Secondary	Participant report of fecal incontinence discussion		same day (within one week of appointment)	No
Secondary	MD/NP initiated urinary incontinence discussion (per participant report)			No
Secondary	MD/NP initiate discussion of Fecal incontinence per participant report			No
Secondary	Urinary Incontinence History Score (Assessed from Clinic Note)			No
Secondary	Fecal Incontinence History Score (Assessed from Clinic Note)			No
Secondary	Urinary Incontinence Assessment and Treatment Score (from Clinic Note)			No
Secondary	Fecal Incontinence Assessment & Treatment Score (from Clinic Note)			No
Secondary	Any Urinary Incontinence Treatment or Referral (per clinic note)			No
Secondary	Any treatment or referral for fecal incontinence? (per clinic note)			No
Secondary	Diagnostic code given - Urinary incontinence			No
Secondary	Diagnostic code given - fecal incontinence			No
Secondary	Urinary incontinence detected		clinic visit	No
Secondary	fecal incontinence detected		clinic visit	No