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Characteristics Predictive of Pessary Success

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01123213
First received: May 12, 2010
Last updated: May 13, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition
All Patients Who Have Undergone a Pessary Fitting.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Characteristics Predictive of Pessary Success

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123213

Locations
United States, California
UC Irvine Women's Healthcare
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen Noblett, MD UCI Medical Center
  More Information

No publications provided

Responsible Party: Karen Noblett, MD, UCI Medical Center
ClinicalTrials.gov Identifier: NCT01123213     History of Changes
Other Study ID Numbers: 2008-6704
Study First Received: May 12, 2010
Last Updated: May 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
pelvic organ prolapse
pessary fitting

ClinicalTrials.gov processed this record on May 16, 2013