The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
Study Type
OBSERVATIONAL
Enrollment
100
There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States
RECRUITINGUMPC
Pittsburgh, Pennsylvania, United States
RECRUITINGUniversitatsklinikum Tubingen
Tübingen, Germany
RECRUITINGPhysical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange
Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam.
Time frame: Post-surgery through study completion, approximately 7 yrs
Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire
Time frame: Post-surgery through study completion, approximately 7yrs
Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
Time frame: Post-surgery through study completion, approximately 7yrs
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Time frame: Post-surgery through study completion, approximately 7yrs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.