Overview

Background

The surgical implementation of synthetic mesh in the repair of pelvic organ prolapse is perhaps the single most controversial and arguably the most important topic within the field of pelvic reconstructive surgery. The controversy stems primarily from a paucity of definitive data addressing postoperative complications and surgical outcomes. Many medical centers are actively engaged in research designed to contribute to our understanding of the performance, risks and benefits of placing vaginal mesh. However, the diversity of synthetic mesh products and surgical approaches makes application of this information problematic. A surgical registry allows for the establishment of a case denominator, which will define a baseline risk/benefit assessment to vaginal mesh and will facilitate future comparative analyses.

Design

This project is a regional multi-centered prospective observational surgeon-generated registry of synthetic permanent mesh placed for the surgical correction of urinary incontinence or pelvic organ prolapse. Primary outcomes will include information about “real-world” use of vaginal mesh, interval objective and subjective outcome measurements. Active surveillance will incorporate the hospital surgical log of implantable devices to ensure full reporting by participating surgeons.

Participation in the registry will be available to all interested surgeons who agree to enroll all of their reconstructive and incontinence cases. Case enrollment will occur immediately postoperatively (in the OR) and will include intra-operative complications. Twenty-five pelvic surgeons who use vaginal mesh have already agreed to 100% reporting to the PRISM Registry project.

Participating surgeons will submit postoperative objective interval outcome data points for their registered cases. Ongoing data collection will allow for cohort studies to report complications, subjective and objective outcomes. Interval postoperative patient satisfaction questionnaires will provide subjective outcome assessments.

Goals

  1. To establish an accurate regional database which represents all uses of synthetic vaginal mesh, related complications and surgical outcomes.
  2. To achieve a better understanding of vaginal mesh and it’s role in pelvic reconstructive surgery.
  3. To improve patient care by combining both individual and collective data to safely and effectively treat pelvic organ prolapse and incontinence.
  4. To ensure the safety of our clinical practice by enabling quality assurance evaluation.
  5. To improve the field of urogynecology by providing information about and evidence for our clinical practice.
  6. To offer our patients unequivocal evidence and appropriate expectations.
  7. To encourage supportive collaboration among surgeons.