The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.
Study Type
OBSERVATIONAL
Enrollment
810
Recurrence of Prolapse
Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Time frame: 12 Month
Rate of device and procedure related serious adverse events
Time frame: 12 Month
Recurrence of Prolapse
Recurrent prolapse is measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Time frame: 12 Month
Recurrence of Prolapse
Recurrent Prolapse is measured anatomically by leading edge of prolapse in the target compartment beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Time frame: 36 Month
Recurrence of Prolapse
Recurrent Prolapse measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Time frame: 36 Month
Device or Procedure related AEs of interest
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sherry Thomas, M.D.
Agoura Hills, California, United States
Stanford University
Stanford, California, United States
SurgOne Pelvic Solutions Center
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Center for Urogynecology and Pelvic Surgery, Christiana Care Health System
Newark, Delaware, United States
MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery
Washington D.C., District of Columbia, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Andrew Shapiro
Owings Mills, Maryland, United States
Baystate Health System
Springfield, Massachusetts, United States
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States
...and 39 more locations