The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

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Copyright © 2020 American Urogynecologic Society. All rights reserved.

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E.E. receives grant funding from NIH/National Center for Advancing Translational Sciences NCATS KL2TR001088; S.M. receives honoraria from UpToDate is a board member of the American Urogynecologic Society; Y.M.K. receives grant funding and salary supported by National Institutes of Health (NIH)/National Center for Complementary and Integrative Health R01AT007171; C.A.F. receives unrestricted research grants from Coloplast, Inc, and Caldera, Inc, and royalties from UpToDate, Inc; D.D.R. receives grant funding and investigator-initiated research with Pfizer (study drug provided by company), R01 AG047290; D.M. is a government employee (NIH/NICHD); H.E.R. receives grant funding from NICHD/National Institute on Aging and Pelvalon, is consultant to Pelvalon, Bluewind, and Renovia, receives royalties from Up to Date, and is board member of the Society of Gynecologic Surgeons, World Wide Fistula Fund. The other authors have declared they have no conflicts of interest.