Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products (POWER1012)
|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.|
|ClinicalTrials.gov Identifier: NCT00388947|
Recruitment Status : Completed
First Posted : October 17, 2006
Results First Posted : November 20, 2012
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment|
|Vaginal Prolapse||Device: AMS Prolapse Product|
The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for up to 2 years and collected demographic, clinical, surgical, safety, and patient outcomes data.
The registry was a web-based system in which surgeons entered patient information with regard to their prolapse surgery. All information entered was de-identified (no names, no date of birth, no date of surgery, etc).
|Study Type :||Observational|
|Actual Enrollment :||1543 participants|
|Official Title:||The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse|
|Study Start Date :||September 2006|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
AMS Prolapse Product (AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family)
Device: AMS Prolapse Product
AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family
Other Name: Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior
- Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device [ Time Frame: up to 2-years post-implant ]
- Prolapse Efficacy Success Rate [ Time Frame: 24 months ]Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used.
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): NCT00388947
|United States, Massachusetts|
|Samuel Zylstra, MD|
|Whitinsville, Massachusetts, United States, 01588|
|Principal Investigator:||Samuel Zylstra, MD||Whitinsville Medical Center|