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

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.

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).

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.