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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536221
• Other study ID #: STUDY00003436
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Fecal Incontinence
• Pelvic Floor Disorders
• Prolapse
• Urinary Incontinence

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Epub 2005 Apr 26 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolapse	Prevalence of prolapse in the population studied	Aug-Sep 2018
Primary	Urinary incontinence	Prevalence of urinary incontinence in the population studied	Aug-Sep 2018
Primary	Fecal incontinence	Prevalence of fecal incontinence in the population studied	Aug-Sep 2018
Primary	Bladder pain	Prevalence of bladder pain in the population studied	Aug-Sep 2018

External Links

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