Faculty Bibliography

OBJECTIVE:To evaluate a GABAergic, melatonergic, and glutamatergic supplement for enhancing sleep quality in perimenopausal and postmenopausal women with low vasomotor symptom (VMS) burden. METHODS:A randomized, double-blind, placebo-controlled, decentralized trial (NCT07375095) was performed in healthy perimenopausal and postmenopausal women with moderate-to-severe sleep disturbance (patient-reported outcome measure information system sleep disturbance [PROMIS SD] SF 8b T-score ≥60) and minimal VMS (≤5 hot flashes and ≤2 night sweats/wk). Participants were randomized to a neurotransmitter-modulating supplement (NMS; L-theanine, gamma-aminobutyric acid, magnesium, S-adenosyl methionine, propyl gallate) or placebo for three weeks. Primary outcomes were changes in PROMIS SD and sleep-related impairment T-scores and responder rates. Secondary outcomes included diary-based total sleep time, sleep efficiency, and visual analog ratings of sleepiness and daytime functioning. RESULTS:Of 128 randomized participants, 127 completed the trial (NMS, n = 65; placebo, n = 62). Baseline characteristics and VMS frequency were similar between groups (3.0 ± 4.0 hot flashes and 1.9 ± 1.7 night sweats/wk). At week 3, NMS significantly improved PROMIS SD T-score (LS mean difference: -11.1 [95% CI, -13.6 to -8.6]; P = 0.0012) and responder rate (90.9% vs. 45.2%; P < 0.001) versus placebo. PROMIS sleep-related impairment T-score (-4.8 [95% CI, -7.3 to -2.3]; P < 0.001) and responder rate (50.8% vs. 32.2%; P = 0.047) also improved. All primary endpoints reached significance by week 2. NMS increased total sleep time by 40.9 minutes versus a 14.9-minute decrease with placebo (P < 0.001), and sleep efficiency improved by 7.4% versus 3.4% (P = 0.021). No between-group differences in adverse events were observed. CONCLUSION/CONCLUSIONS:In perimenopausal and postmenopausal women with disrupted sleep but minimal VMS, a NMS significantly improved sleep quality and duration.

The prevalence of uterine sarcoma, typically leiomyosarcoma, is greater than previously believed, with current data indicating a risk as high as one in 770 women undergoing surgery for presumed leiomyomas (uterine fibroids). Presurgical detection of uterine sarcoma is an important clinical concern for gynecologists and gynecologic oncologists worldwide. Inadvertent minimally invasive treatment of unsuspected uterine leiomyosarcoma may delay definitive therapy or lead to disease dissemination. Contrast-enhanced MRI with diffusion-weighted imaging and apparent diffusion coefficient measurement provides high accuracy (88%-94.6%) in detecting uterine leiomyosarcoma, making radiologists valuable partners to gynecologists in risk assessment and disease management. The algorithm outlined in the Radiology 2023 MRI Evaluation of Uterine Masses for Risk of Leiomyosarcoma consensus statement has been preliminarily validated, and the authors present additional nuances to enhance its application in clinical practice.

AIMS/UNASSIGNED:To evaluate the clinical and economic value of onabotulinumtoxinA (onabotA) vs oral pharmacotherapies for adults with OAB inadequately managed with anticholinergics from a United States (US) Medicare + societal perspective over 1 year. MATERIALS AND METHODS/UNASSIGNED:A Markov model-based 1-year cost per responder (CPR) analysis was conducted for patients achieving complete response (100% reduction in urinary incontinence episodes [i.e. complete dryness]). Comparators included onabotA and oral therapies (vibegron [brand], mirabegron 25/50 mg [brand and generic], and anticholinergics [generic]), using inputs for efficacy, costs, and healthcare resource use. The primary outcome was CPR for a complete response, with secondary outcomes including number of urinary incontinence episodes per patient and number needed to treat (NNT). Uncertainty was evaluated through one-way and probabilistic sensitivity analyses. Scenario analyses assessed results using commercial costs and longer-term effects for selected outcomes. RESULTS/UNASSIGNED:In the base-case analysis, onabotA had the highest complete response rate (23.5%), resulting in the lowest NNT and CPR (4.3; $18,646) vs oral therapies (response 10.9-12.1%; NNT 8.3-9.2; CPR $21,941-$49,524). Scenario and sensitivity analyses were consistent with these findings and supported the base-case results. LIMITATIONS/UNASSIGNED:Model inputs were primarily based on clinical trial data and may not fully reflect real-world practice; differences across trials may limit comparability. The stringent responder definition, use of non-US productivity estimates, 1-year time horizon, and exclusion of neuromodulation therapies may further limit generalizability and scope. CONCLUSIONS/UNASSIGNED:OnabotA demonstrated favorable clinical and economic value relative to oral pharmacotherapies that was consistent across sensitivity and scenario analyses. About 1 in 4 patients treated with onabotA could achieve a 100% response over 1 year compared to 1 in at least 8 with oral pharmacotherapies. These findings support onabotA as a treatment option with demonstrated clinical and economic value for patients who do not achieve adequate symptom relief with oral OAB therapies.

BACKGROUND:Chorioamnionitis has serious maternal-newborn risks. Risk factors include prelabor rupture of membranes (PROM), vaginal exams, and inadequate perineal hygiene. There may be opportunities to reduce chorioamnionitis with PROM and newborns affected by chorioamnionitis within the Joint Commission Measure of Unexpected Newborn Complications (PC-06) using an infection prevention bundle. PROBLEM/OBJECTIVE:An internal audit found an increased incidence of newborns born to women with chorioamnionitis. Patients with PROM had a 6.2% chorioamnionitis rate compared to a 3.6% overall chorioamnionitis rate. INTERVENTIONS/METHODS:A quality improvement project using an infection prevention bundle for PROM was implemented using three interventions: avoiding unnecessary vaginal exams in PROM diagnosis, hourly pericare with peripad changes, and hand hygiene compliance. RESULTS:Data were compared from first quarter 2023 before bundle implementation through third quarter 2023 post bundle implementation. The rate of chorioamnionitis was decreased among patients with PROM from 8.1% (9/111) in first quarter 2023 to 3.1% (4/126) in third quarter 2023. There were fewer newborns affected by chorioamnionitis within PC-06, from 9% (3/32) in first quarter 2023 to 7% (3/46) in third quarter 2023. PROM with chorioamnionitis within PC-06 was 0% (0/32) at first and (0/46) third quarter 2023. CONCLUSIONS:Bundle adherence with PROM could help decrease chorioamnionitis and contribute to fewer newborn complications related to chorioamnionitis.

INTRODUCTION/BACKGROUND:Persistent cloaca occurs in approximately 1 in 25,000 live births. Among patients with cloaca, the absence of a vaginal connection to the common channel represents a rare phenotype with distinct anatomic and management considerations. We describe the urologic, gynecologic, and surgical characteristics of this patient subset. METHODS:We performed a retrospective analysis of a single-institution cohort of patients with persistent cloaca managed at a quaternary-care children's hospital between 2019 and 2025. Patients were eligible if they underwent primary cloacal repair by our multidisciplinary team and met all three diagnostic criteria for absent vaginal-common channel fistula: no hydrocolpos on imaging, no identified vaginal opening on cystoscopy or cloacagram, and no visible lumen between müllerian and cloacal structures identified intraoperatively. RESULTS:Of 51 patients who underwent primary repair, 6 (12%) met criteria for absent vaginal-common channel fistula. All met criteria for VACTEGRLS association. Common channel length ranged from 1.1 to 7.0 cm and urethral length from 0.5 to 2.2 cm. Urologic anomalies were nearly universal: five patients (83%) had a solitary functional kidney and four (67%) had vesicoureteral reflux. All underwent posterior sagittal anorectoplasty (PSARP) for rectal repair with the common channel repurposed as the neourethra. Five (83%) underwent diagnostic laparoscopy during which the müllerian structures were examined but left in situ. At last follow-up (median 17.5 months, range 4-35 months), three patients (50%) had volitional voiding and three (50%) required assisted bladder emptying via vesicostomy or Mitrofanoff. CONCLUSION/CONCLUSIONS:Persistent cloaca without a vaginal-common channel fistula represents a rare but clinically distinct phenotype characterized by severe urologic anomalies. Recognition of this phenotype is essential for surgical planning and long-term urologic and gynecologic surveillance. Because there was no connection between the vagina and the urinary tract, delaying management of the müllerian structures did not adversely affect the urinary tract.

STUDY OBJECTIVE/OBJECTIVE:Published information on the sexual health and well-being of individuals with complete androgen insensitivity syndrome (CAIS) remains limited. In this study, we aimed to evaluate the vaginal lengths, sexual well-being and body image findings of a relatively large, young cohort of individuals with CAIS, with the goal of guiding clinical practice toward more accurate and individualized patient-centered counseling. METHODS:In this interim analysis of a prospective IRB-approved AIS Natural History Study funded by the National Institutes of Health (NIH), we collected demographic information and vaginal length measurements from 23 individuals with CAIS between 2021 and 2025. Participants over 18 were invited to complete the PROMIS Sexual Function and Satisfaction (PROMIS SexFS) questionnaire and the Body Image Scale (BIS) questionnaire. RESULTS:The cohort (n = 23) ranged in age from 14 to 65 (median = 19). Fourteen participants (61%) identified as heterosexual, 7 (30%) had undergone complete gonadectomy, and 1 had undergone vaginoplasty. Three participants reported practicing serial vaginal dilations. Vaginal length measurements (n = 14) ranged from 25 to 90mm (median = 60mm). Of those who completed the PROMIS SexFS (n = 11), mean t-scores were within one standard deviation of normalized U.S. female population ranges. Of those who completed the BIS (n = 15), the average mean-item score was 0.9 on a Likert scale from 0 "not at all" to 3 "very much". CONCLUSION/CONCLUSIONS:Aside from one outlier, vaginal lengths in our cohort did not differ significantly from those reported in the general population, and most participants reported a positive body image and the ability to engage in fulfilling sexual activity.

PURPOSE/OBJECTIVE:While guidelines emphasize the benefits of multimodal anesthesia for hysterectomy procedures, including regional anesthesia (RA), utilization rates remain understudied. This study described multilevel factors associated with RA receipt across the US Military Health System. METHODS:This retrospective cohort study included patients undergoing a hysterectomy between January 2022 and April 2025 (N = 5,150). Patient- (e.g., demographic and clinical information), care- (e.g., route, surgical duration, adjuncts), and system- (e.g., facility) level factors were covariates in a generalized additive mixed-effects model (GAMM) evaluating RA receipt. RESULTS:Overall, 13% received RA. Across 33 facilities, RA use ranged from 0 to 66% (median 9%, IQR 3-15%). In the GAMM, surgical facility accounted for 23% of the outcome variance. Odds (95% CI) of RA receipt were higher for patients with a Charlson Comorbidity Index of 1 relative to 0 (OR = 1.33, 1.03-1.71, p = 0.03), with leiomyoma diagnoses (OR = 1.26, 1.01-1.58, p = 0.04), and who received an open hysterectomy (OR = 6.02, 4.55-7.96, p < 0.001) and more adjuncts (OR = 1.15, 1.05-1.27, p = 0.005). The smooth effect of age was significant (p = 0.03), such increasing age was associated with lower odds of RA receipt. CONCLUSION/CONCLUSIONS:RA receipt was not common; variability was largely attributed to facility. Patients receiving RA tended to receive more adjuncts (e.g., dexmedetomidine, ketamine, NSAID, acetaminophen, gabapentinoids), which suggests anesthesia clinicians who use RA are also those who more frequently use multimodal analgesia. Further research is needed to evaluate acute and subacute hysterectomy outcomes that accounts for the full range of anesthesia and analgesia selection, as well as clinician practice patterns and motivations for RA use.