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Characteristics Predictive of Pessary Success

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123213
First Posted: May 14, 2010
Last Update Posted: July 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karen Noblett, University of California, Irvine
  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

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

Enrollment: 158
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Karen Noblett, Division Director, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01123213     History of Changes
Other Study ID Numbers: 2008-6704
First Submitted: May 12, 2010
First Posted: May 14, 2010
Last Update Posted: July 1, 2013
Last Verified: June 2013

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