NCT00388947

Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,543 (actual)
• Sponsor: ASTORA Women's Health · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

Detailed description

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).

Conditions

• Vaginal Prolapse

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2006-10-17
• Last updated: 2016-08-11
• Results posted: 2012-11-20

Locations

1 site across 1 country: United States