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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014