- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123213
Characteristics Predictive of Pessary Success
February 5, 2018 updated by: Karen Noblett, University of California, Irvine
Pessaries are mechanical support devices worn vaginally to treat the symptoms of pelvic organ prolapse, such as vaginal pressure or a vaginal bulge.
Pessaries are one of the options along with surgery and expectant management for pelvic organ prolapse.
As the aging population grows, more patients will need treatment for pelvic organ prolapse.
Various studies have been conducted previously to identify patient parameters predictive of successful pessary fitting and continued use.
Our study is a retrospective chart review to identify patient characteristics predictive of successful pessary fitting and use, specifically focusing on the parameters of POPQ, pelvic organ prolapse quantification exam, and the ratio of the genital hiatus, which is the length of the vaginal opening, and total vaginal length.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
158
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Orange, California, United States, 92868
- UC Irvine Women's Healthcare
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All patients who have undergone a pessary fitting by physicians in the division of Urogynecology between the years of 2000 to 20008 will be eligible.
Description
Inclusion Criteria:
- undergone a pessary fitting by physicians in the division of Urogynecology between the years of 2000 to 20008.
Exclusion Criteria:
- Patients will be excluded only if their chart does not contain the clinical data under review.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
May 12, 2010
First Submitted That Met QC Criteria
May 13, 2010
First Posted (Estimate)
May 14, 2010
Study Record Updates
Last Update Posted (Actual)
February 7, 2018
Last Update Submitted That Met QC Criteria
February 5, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-6704
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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