NCT00880880

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
Last Updated

October 5, 2015

Status Verified

April 1, 2009

Enrollment Period

1 year

First QC Date

April 13, 2009

Last Update Submit

October 1, 2015

Conditions

Urinary IncontinenceFecal IncontinencePelvic Floor Disorders

Keywords

urinary incontinencefecal incontinencecommunication

Outcome Measures

Primary Outcomes (1)

  • Mention of urinary incontinence in the clinic visit note

Secondary Outcomes (15)

  • Mention of fecal incontinence in the clinic visit note

  • Participant report of urinary discussion

    same day (within one week of appointment)

  • Participant report of fecal incontinence discussion

    same day (within one week of appointment)

  • MD/NP initiated urinary incontinence discussion (per participant report)

  • MD/NP initiate discussion of Fecal incontinence per participant report

  • +10 more secondary outcomes

Study Arms (2)

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

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.

Interventions

e-PAQ-PFOTHER

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.

Also known as: electronic personal assessment questionnaire - pelvic floor, electronic pelvic floor questionnaire
pre-visit e-PAQ-PF

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Health Women's Health Internal Medicine West

Madison, Wisconsin, 53717, United States

Location

Related Publications (1)

  • 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.

    PMID: 26555779DERIVED

MeSH Terms

Conditions

Urinary IncontinenceFecal IncontinencePelvic Floor DisordersCommunication

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPregnancy ComplicationsBehavior

Study Officials

  • Chris M Schussler-Fiorenza, MD

    University of Wisconsin School of Medicine & Public Health

    PRINCIPAL INVESTIGATOR

  • Ronald E Gangnon, PhD

    University of Wisconsin, Madison

    STUDY CHAIR

  • Arnold Wald, MD

    University of Wisconsin School of Medicine & Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

August 1, 2007

Primary Completion

August 1, 2008

Last Updated

October 5, 2015

Record last verified: 2009-04

Locations

US(1)