Urinary IncontinenceNCT00880880
Improving Women's Health by Using an Electronic Pelvic Floor Questionnaire
A study testing e-PAQ-PF in people with Urinary Incontinence and Fecal Incontinence, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Fecal Incontinence, Pelvic Floor Disorders
- What is being tested?
- e-PAQ-PF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Woman
- Aged 40 and older
- Scheduled for a well visit at the Women's Health Internal Medicine West Clinic
Who cannot join
- Unable to speak English
- Unable to fill out questionnaire
- Excluded by patient's clinician prior to recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Health Women's Health Internal Medicine West
Madison, Wisconsin, 53717
About this study
Official title: Improving the Assessment of Women's Health Through the Use of a Computerized Pelvic Floor Questionnaire
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.
- Being tested
- e-PAQ-PF
- Keywords
- urinary incontinence, fecal incontinence, communication
- Medical subject headings
- Urinary Incontinence, Fecal Incontinence, Pelvic Floor Disorders, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-PAQ-PFOther
Also called electronic personal assessment questionnaire - pelvic floor, electronic pelvic floor questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: same day (within one week of appointment)
Participant report of fecal incontinence discussion
Measured: 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
Urinary Incontinence History Score (Assessed from Clinic Note)
Fecal Incontinence History Score (Assessed from Clinic Note)
Urinary Incontinence Assessment and Treatment Score (from Clinic Note)
Fecal Incontinence Assessment & Treatment Score (from Clinic Note)
Any Urinary Incontinence Treatment or Referral (per clinic note)
Any treatment or referral for fecal incontinence? (per clinic note)
Diagnostic code given - Urinary incontinence
Diagnostic code given - fecal incontinence
Urinary incontinence detected
Measured: clinic visit
fecal incontinence detected
Measured: clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startAug 2007
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Xi Society, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Chris M Schussler-Fiorenza, MD, Principal investigator, University of Wisconsin School of Medicine & Public HealthRonald E Gangnon, PhD, Study chair, University of Wisconsin, MadisonArnold Wald, MD, Principal investigator, University of Wisconsin School of Medicine & Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880880
- Sponsor's protocol ID
- HS17028
- Other IDs
- 1R36HS017028-01A1
- Status last verified
- Apr 2009
- First submitted
- 13 Apr 2009
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26555779
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Assessment of Women's Health Through the Use of a Computerized Pelvic Floor Questionnaire
- ClinicalTrials.gov ID
- NCT00880880
- Acronym / sponsor ID
- HS17028
- Keywords
- urinary incontinence, fecal incontinence, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Sigma Xi Society, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-visit e-PAQ-PF | Experimental | Other: e-PAQ-PFParticipants 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. |
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Woman
- Aged 40 and older
- Scheduled for a well visit at the Women's Health Internal Medicine West Clinic
Key exclusion criteria (3 listed)
- Unable to speak English
- Unable to fill out questionnaire
- Excluded by patient's clinician prior to recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-PAQ-PFAlso: electronic personal assessment questionnaire - pelvic floor, electronic pelvic floor questionnaireParticipants 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 | pre-visit e-PAQ-PF |
Primary outcome
Mention of urinary incontinence in the clinic visit note
15 secondary outcomes
Mention of fecal incontinence in the clinic visit note
Participant report of urinary discussion
Time frame: same day (within one week of appointment)
Participant report of fecal incontinence discussion
Time frame: 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
Urinary Incontinence History Score (Assessed from Clinic Note)
Fecal Incontinence History Score (Assessed from Clinic Note)
Urinary Incontinence Assessment and Treatment Score (from Clinic Note)
Fecal Incontinence Assessment & Treatment Score (from Clinic Note)
Any Urinary Incontinence Treatment or Referral (per clinic note)
Any treatment or referral for fecal incontinence? (per clinic note)
Diagnostic code given - Urinary incontinence
Diagnostic code given - fecal incontinence
Urinary incontinence detected
Time frame: clinic visit
fecal incontinence detected
Time frame: clinic visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Derived from this study: PubMed 26555779Schussler-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris M Schussler-Fiorenza, MD principal investigator
University of Wisconsin School of Medicine & Public Health
Ronald E Gangnon, PhD study chair
University of Wisconsin, Madison
Arnold Wald, MD principal investigator
University of Wisconsin School of Medicine & Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-PAQ-PF in people with Urinary Incontinence and Fecal Incontinence, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mention of urinary incontinence in the clinic visit note. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.