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

ASTORA Women's Health1,543 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,543

Conditions

Vaginal Prolapse

Interventions

AMS Prolapse ProductDEVICE

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

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Samuel Zylstra, MD

Whitinsville, Massachusetts, United States

Outcomes

Primary Outcomes

Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device

Time frame: up to 2-years post-implant

Secondary Outcomes

Prolapse Efficacy Success Rate

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.

Time frame: 24 months

Data from ClinicalTrials.gov

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