Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products (POWER1012)

Astora Women's Health

Status: Completed

Conditions: Vaginal Prolapse

Treatments: Device: AMS Prolapse Product

Study type: Observational

Funder types: Industry

Identifiers

NCT00388947

1012

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,543 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female at least 21 years old
• Has pelvic organ prolapse requiring surgical repair
• Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse

Exclusion criteria

• Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.

Trial design

1,543 participants in 1 patient group

1

Description:

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)

Treatment:

Device: AMS Prolapse Product