Background Uterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging–guided focused ultrasound surgery are minimally invasive therapies approved by the United States Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments. (NCT00995878, clinicaltrials.gov) Objective To summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment. Study Design Premenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n=57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n=34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected. Results Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P<.001). Of women undergoing focused ultrasound (n=43), 23 (53%) underwent 2 treatment days. Immediate self-rated postprocedure pain was higher after uterine artery embolization than focused ultrasound (median [interquartile range], 5 [1–7] vs 1 [1–4]; P=.002). Compared with those having focused ultrasound (n=39), women undergoing embolization (n=36) were more likely to use outpatient opioid (75% vs 21%; P<.001) and nonsteroidal anti-inflammatory medications (97% vs 67%; P<.001) and to have a longer median (interquartile range) recovery time (days off work, 8 [6–14] vs 4 [2–7]; P<.001; days until returned to normal, 15 [10–29] vs 10 [10–15]; P=.02). There were no significant differences in the incidence or severity of adverse events between treatment arms; 86% (42/49) of adverse events required only observation or nominal treatment, and no events caused permanent sequelae or death. After adjustment for baseline pain and uterine fibroid load, uterine artery embolization was still significantly associated with higher opioid use and lon...
Background: Uterine leiomyomas (fibroids) cause considerable symptoms in 30% to 50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroids often seek uterine-preserving treatments, but comparative effectiveness trials are lacking.Objective: To report treatment effectiveness and ovarian function after uterine artery embolization versus magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study.Study Design: Fibroid Interventions: Reducing Symptoms Today and Tomorrow, a randomized controlled trial of uterine artery embolization versus magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroids; women declining randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroids within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function.Results: During 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 magnetic resonance imaging-guided focused ultrasound surgery Laughlin-Tommaso et al.
Predicting release from degradable hydrogels is challenging but highly valuable in a multitude of applications such as drug delivery and tissue engineering. In this study, we developed a simple mathematical and computational model that accounts for time-varying diffusivity and geometry to predict solute release profiles from degradable hydrogels. Our approach was to use time snapshots of diffusivity and hydrogel geometry data measured experimentally as inputs to a computational model which predicts release profile. We used two model proteins of varying molecular weights: bovine serum albumin (BSA; 66 kDa) and immunoglobulin G (IgG; 150 kDa). We used fluorescence correlation spectroscopy (FCS) to determine protein diffusivity as a function of hydrogel degradation. We tracked changes in gel geometry over the same time period. Curve fits to the diffusivity and geometry data were used as inputs to the computational model to predict the protein release profiles from the degradable hydrogels. We validated the model using conventional bulk release experiments. Because we approached the hydrogel as a black box, the model is particularly valuable for hydrogel systems whose degradation mechanisms are not known or cannot be accurately modeled.
BACKGROUND: Fertility preservation enables patients undergoing gonadotoxic therapies to retain the potential for biological children and now has broader implications in the care of transgender individuals. Multiple medical societies recommend counseling on fertility preservation before initiating therapy for gender dysphoria; however, outcome data pre-and posttreatment are limited in feminizing transgender adolescents and young adults. METHODS: The University of Pittsburgh Institutional Research Board approved this study. Data were collected retrospectively on transgender patients seeking fertility preservation between 2015 and 2018, including age at initial consultation and semen analysis parameters.
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