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A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System

This study has been completed.
Sponsor:
Information provided by:
The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
ClinicalTrials.gov Identifier:
NCT01134003
First received: May 27, 2010
Last updated: May 28, 2010
Last verified: May 2010
History of Changes
  Purpose

retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System


Condition
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania:

Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population

women receiving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift

Criteria

Inclusion Criteria:

  • women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134003

Locations
United States, Pennsylvania
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
  More Information

No publications provided

Responsible Party: Dr. Vincent Lucente, Institute for Female Pelvic Medicine
ClinicalTrials.gov Identifier: NCT01134003     History of Changes
Other Study ID Numbers: SLHN 2007-98
Study First Received: May 27, 2010
Last Updated: May 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania:
Gynecare Prolift
Pelvic organ prolapse
forming a large database of women who have recieve Gynecare prolift system

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013