Prolapse Genital Clinical Trial
Official title:
Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device
Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.
112 women operated by two surgeons at one center (2 years follow up) are to be compared to
207 women operated by twenty six surgeons at twenty four centers (1 year follow-up).
Screening at baseline for apical (uterine or vaginal vault) prolapse stage II with or without
concomitant anterior or vaginal wall prolapse ≥ stage 2 according to the pelvic organ
prolapse quantification (POP-Q) system.
Surgical data including operation data, complications and hospital stay are to be compared.
Anatomical outcome measurements by POP-Q evaluations. Subjective symptoms are to be evaluated
by prolapse specific symptom questionnaires (PFIQ-7, UDI-6 and PFIQ) whereas sexual function
to be estimated by PISQ-12.
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