Clinical trial NCT03536221: What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?
Official title: D2D What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapse
Urinary Incontinence
Fecal Incontinence
Bladder Pain Syndrome
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prolapse
timeFrame: Aug-Sep 2018
measure: Urinary incontinence
timeFrame: Aug-Sep 2018
measure: Fecal incontinence
timeFrame: Aug-Sep 2018
measure: Bladder pain
timeFrame: Aug-Sep 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.