ProlapseNCT03536221
What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?
An observational study of Prolapse and Urinary Incontinence, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse, Urinary Incontinence, Fecal Incontinence
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Sep 2019
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women aged 18 years and older who attend the Minnesota State Fair and are willing to participate in the survey.
Who may be able to join
- 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.
Who cannot join
- Inability to provide consent to take the survey, and inability to speak and understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Prolapse, Urinary Incontinence, Fecal Incontinence, Cystitis, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolapse
Prevalence of prolapse in the population studied
Measured: Aug-Sep 2018
Urinary incontinence
Prevalence of urinary incontinence in the population studied
Measured: Aug-Sep 2018
Fecal incontinence
Prevalence of fecal incontinence in the population studied
Measured: Aug-Sep 2018
Bladder pain
Prevalence of bladder pain in the population studied
Measured: Aug-Sep 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Aug 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ProlapseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536221
- Sponsor's protocol ID
- STUDY00003436
- Status last verified
- Oct 2019
- First submitted
- 14 May 2018
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan at present
Publications
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.
PubMed 23321654Olsen 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.
PubMed 9083302Wu 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.
PubMed 21600549Lukacz 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.
PubMed 15856132
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D2D What is the Prevalence of Female Pelvic Floor Disorders in Minnesota?
- ClinicalTrials.gov ID
- NCT03536221
- Acronym / sponsor ID
- STUDY00003436
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 24 May 2018 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years and older who attend the Minnesota State Fair and are willing to participate in the survey.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide consent to take the survey, and inability to speak and understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prolapse
Time frame: Aug-Sep 2018
Prevalence of prolapse in the population studied
Urinary incontinence
Time frame: Aug-Sep 2018
Prevalence of urinary incontinence in the population studied
Fecal incontinence
Time frame: Aug-Sep 2018
Prevalence of fecal incontinence in the population studied
Bladder pain
Time frame: Aug-Sep 2018
Prevalence of bladder pain in the population studied
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 1 Nov 2019.
- Background: PubMed 23321654Egger 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.
- Results publication: PubMed 9083302Olsen 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.
- Results publication: PubMed 21600549Wu 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.
- Results publication: PubMed 15856132Lukacz 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.
- Predicted growth of Minnesota's populationLink provided by the sponsor.
- Age breakdown of Minnesota's predicted growthLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. No plan at present
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse and Urinary Incontinence, run by University of Minnesota 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 1 inclusion and 1 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 1 Nov 2019. 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?
Prolapse (time frame: Aug-Sep 2018). The study lists 4 primary outcomes in all. 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 NCT03536221, which also lists 4 linked publications.
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 1 Nov 2019.