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Outcomes by frailty and mobility in older patients undergoing major urogynecologic surgery
A planned supplementary study of the ASPIRe trial
Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (2025). Outcomes by frailty and mobility in older patients undergoing major urogynecologic surgery: A planned supplementary study of the ASPIRe trial. American Journal of Obstetrics and Gynecology. Advance online publication. https://doi.org/10.1016/j.ajog.2025.11.002
OBJECTIVE: The impact of frailty and compromised mobility on immediate postoperative complications, geriatric outcomes, and treatment failure after prolapse surgery remains uncertain. The objective of this study was to prospectively characterize frailty and mobility and their impact on immediate postoperative complications, geriatric outcomes, and treatment success in older patients undergoing major urogynecologic surgery for pelvic organ prolapse.
STUDY DESIGN: A nested prospective cohort study within a three-arm randomized clinical trial was conducted at nine clinical sites in 146 participants. Participants aged ≥ 65 years with symptomatic vaginal vault prolapse underwent baseline assessments of frailty and compromised mobility. Frailty was measured using the Robinson Frailty Index. The Robinson frailty index score ranges from 0 to 7 and scores ≥2 were considered pre-frail/frail. Compromised mobility was defined as either TUG≥15sec, use of an assistive device, or observed gait difficulties. The primary outcome was immediate postoperative moderate to severe adverse events assessed according to the Clavien-Dindo Severity Classification (Grade ≥ II). Geriatric-specific outcomes included 30-day postoperative complications, need for increased social support assessed 6-weeks post-op, falls, new admission to skilled nursing facilities, all-cause hospital admissions, and mortality. Treatment outcome was time to composite treatment failure. Geriatric and treatment outcomes were assessed biannually for 36 up to 60 months.
RESULTS: 146 supplemental study participants underwent randomized prolapse surgery in the main trial: 50 in the transvaginal native tissue repair, 47 in the abdominal sacral colpopexy, and 48 in the transvaginal mesh repair arms. Compared with non-frail subjects, pre-frail/frail participants experienced no difference in geriatric-specific outcomes. Pre-frail/frail participants living alone before surgery were more likely to require support (family/friends or assistance) in the first six weeks after surgery (19% vs. 6%, p=0.04). Pre-frail/frail and compromised mobility participants had a shorter time to surgical treatment failure than did non-frail or non-compromised patients (frail vs. non-frail adjusted hazard ratio [aHR] 2.1: 95%CI 1.2, 3.6).
CONCLUSIONS: Despite measurable frailty or compromised mobility, many older patients underwent prolapse surgery with few complications; however, enhanced social support was needed in the first six weeks after surgery. Treatment failure was higher in patients with preoperative frailty, suggesting that frailty is important to incorporate in surgical treatment planning for the correction of pelvic organ prolapse in older patients.
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