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

D2D What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Prolapse; Fecal Incontinence; Bladder Pain Syndrome

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 Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years and older who attend the Minnesota State Fair and are willing to participate in the survey.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolapse	Prevalence of prolapse in the population studied	Aug-Sep 2018
Urinary incontinence	Prevalence of urinary incontinence in the population studied	Aug-Sep 2018
Fecal incontinence	Prevalence of fecal incontinence in the population studied	Aug-Sep 2018
Bladder pain	Prevalence of bladder pain in the population studied	Aug-Sep 2018

Collaborators and Investigators

• Sponsor: University of Minnesota

Publications and helpful links

General Publications

• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
• Egger MJ, Lukacz ES, Newhouse M, Wang J, Nygaard I. Web versus paper-based completion of the epidemiology of prolapse and incontinence questionnaire. Female Pelvic Med Reconstr Surg. 2013 Jan-Feb;19(1):17-22. doi: 10.1097/SPV.0b013e31827bfd93.
• Wu JM, Kawasaki A, Hundley AF, Dieter AA, Myers ER, Sung VW. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynecol. 2011 Sep;205(3):230.e1-5. doi: 10.1016/j.ajog.2011.03.046. Epub 2011 Apr 2.
• Lukacz ES, Lawrence JM, Buckwalter JG, Burchette RJ, Nager CW, Luber KM. Epidemiology of prolapse and incontinence questionnaire: validation of a new epidemiologic survey. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jul-Aug;16(4):272-84. doi: 10.1007/s00192-005-1314-5. Epub 2005 Apr 26.

Helpful Links

• Predicted growth of Minnesota's population
• Age breakdown of Minnesota's predicted growth

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pregnancy Complications; Cystitis; Urinary Incontinence; Prolapse; Pelvic Floor Disorders; Cystitis, Interstitial; Fecal Incontinence
• Other Study ID Numbers: STUDY00003436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plan at present

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No