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What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT03536221
Collaborator
(none)
1,200
Enrollment
1
Location
14
Actual Duration (Months)
85.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the prevalence of pelvic organ prolapse and urinary incontinence among women in Minnesota using a short web-based self-administered questionnaire.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will be administered at the 2018 Minnesota State Fair at the Driven to Discover building. The study will be administered entirely for research purposes. All data will be self-reported (see attached survey). Data collection will be through a web-based version of the EPIQ loaded into Research Electronic Data Capture REDCap, a secure web-based system for data collection. Data collection will occur over 6 half day sessions at the University of Minnesota D2D building at the Minnesota State Fair Grounds while the Fair is running.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    D2D What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?
    Actual Study Start Date :
    Aug 1, 2018
    Actual Primary Completion Date :
    Sep 30, 2019
    Actual Study Completion Date :
    Sep 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Prolapse [Aug-Sep 2018]

      Prevalence of prolapse in the population studied

    2. Urinary incontinence [Aug-Sep 2018]

      Prevalence of urinary incontinence in the population studied

    3. Fecal incontinence [Aug-Sep 2018]

      Prevalence of fecal incontinence in the population studied

    4. Bladder pain [Aug-Sep 2018]

      Prevalence of bladder pain in the population studied

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women who are age 18 or older on the date they take the survey who are willing to take the survey. Pregnant women may participate in the survey.
    Exclusion Criteria:
    • Inability to provide consent to take the survey, and inability to speak and understand English.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT03536221
    Other Study ID Numbers:
    • STUDY00003436
    First Posted:
    May 24, 2018
    Last Update Posted:
    Nov 1, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fecal Incontinence
    Urinary Incontinence
    Pelvic Floor Disorders
    Cystitis, Interstitial
    Prolapse

    Study Results

    No Results Posted as of Nov 1, 2019