Virtual Compared With In-Office Postoperative Visits After Urogynecologic Surgery: A Randomized Controlled Trial.

OBJECTIVE: To compare patient satisfaction, health care resource utilization, and adverse events among patients receiving a virtual video compared with in-office postoperative visit after urogynecologic surgery. We hypothesized that virtual video visits would be noninferior to in-office visits. METHODS: This was a randomized noninferiority clinical trial of patients undergoing surgery for pelvic organ prolapse and urinary incontinence at a single academic tertiary referral center. Participants were randomized to receive either a virtual video postoperative visit or a standard in-office postoperative visit. The primary outcome was patient satisfaction measured by the validated PSQ-18 (Patient Satisfaction Questionnaire-18) (noninferiority margin 5 points) at the 6-week postoperative visit. Secondary outcomes included PSQ-18 domain scores (noninferiority margin 0.5 points) and composite health care resource utilization and adverse events after the 6-week postoperative visit up to 12 weeks after surgery (noninferiority margin 10%). A sample size of 100 participants (50 per group) would allow 80% power to assess a 5-point noninferiority margin on the total PSQ-18 with an SD of 10 and α=0.05. RESULTS: From January 2023 to September 2023, 265 patients were screened for eligibility, and 104 were randomized. A total of 100 participants (50 per arm) completed the study and were included in the analysis. The mean±SD age of all participants was 57.0±13.2 years. The mean±SD PSQ-18 total score was 75.18±8.15 in the virtual group and 75.14±8.7 in the in-office group. The mean PSQ-18 total score was 0.04 points higher (ie, greater degree of satisfaction) in the virtual group, with a 95% CI of -2.75 to 2.83, which met the criterion for noninferiority. Between-group differences for all PSQ-18 domain scores likewise met criterion for noninferiority. Composite health care resource utilization was 14.0% lower in the virtual group than in the in-office group (20.0% vs 34.0%, 95% CI, -28.0% to 1.0%). For composite adverse events, the between-group difference was 2.0% (2.0% in virtual group vs 0.0% in in-office group, 95% CI,-3.0% to 8.0%). CONCLUSION: Virtual video postoperative visits were noninferior to in-office visits with regard to patient satisfaction, health care resource utilization, and adverse events and can be offered as an alternative to in-office visits for postoperative follow-up after urogynecologic surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05641077.

A safe insect-based Chikungunya fever vaccine affords rapid and durable protection in cynomolgus macaques.

Chikungunya virus (CHIKV), which induces chikungunya fever and chronic arthralgia, is an emerging public health concern. Safe and efficient vaccination strategies are needed to prevent or mitigate virus-associated acute and chronic morbidities for preparation of future outbreaks. Eilat (EILV)/CHIKV, a chimeric alphavirus which contains the structural proteins of CHIKV and the non-structural proteins of EILV, does not replicate in vertebrate cells. The chimeric virus was previously reported to induce protective adaptive immunity in mice. Here, we assessed the capacity of the virus to induce quick and durable protection in cynomolgus macaques. EILV/CHIKV protected macaques from wild-type (WT) CHIKV infection one year after a single dose vaccination. Transcriptome and in vitro functional analyses reveal that the chimeric virus triggered toll-like receptor signaling and T cell, memory B cell and antibody responses in a dose-dependent manner. Notably, EILV/CHIKV preferentially induced more durable, robust, and broader repertoire of CHIKV-specific T cell responses, compared to a live attenuated CHIKV 181/25 vaccine strain. The insect-based chimeric virus did not cause skin hypersensitivity reactions in guinea pigs sensitized to mosquito bites. Furthermore, EILV/CHIKV induced strong neutralization antibodies and protected cynomolgus macaques from WT CHIKV infection within six days post vaccination. Transcriptome analysis also suggest that the chimeric virus induction of multiple innate immune pathways, including Toll-like receptor signaling, type I IFN and IL-12 signaling, antigen presenting cell activation, and NK receptor signaling. Our findings suggest that EILV/CHIKV is a safe, highly efficacious vaccine, and provides both rapid and long-lasting protection in cynomolgus macaques.

Adjuvanted subunit intranasal vaccine prevents SARS-CoV-2 onward transmission in hamsters.

Most COVID-19 vaccine trials have focused on recipient protection, not protection of their contacts, a critical need. As a subunit intranasal COVID-19 vaccine reduced nasopharyngeal virus more than did an intramuscular (IM) vaccine, we hypothesized that this vaccine might reduce onward transmission to others. We vaccinated hamsters with either the IM-administrated Moderna mRNA vaccine twice or one dose of mRNA IM followed by adjuvanted subunit intranasal vaccine. 24 hours after SARS-CoV-2 challenge, these animals were housed with naïve recipients in a contactless chamber that allows airborne transmission. Onward airborne transmission was profoundly blocked: the donor and recipients of the intranasal vaccine-boosted group had lower oral and lung viral loads (VL), which correlated with mucosal ACE2 inhibition activity. These data strongly support the use of the intranasal vaccine as a boost to protect not only the vaccinated person, but also people exposed to the vaccinated person, a key public health goal. Author summary: Natural transmission of SARS-CoV-2 is primarily airborne, through the respiratory mucosal route. However, current licensed COVID-19 vaccines are all intramuscular and induce more systemic than mucosal immunity. Here, we did a head-to-head comparison of COVID-19 booster vaccines on SARS-CoV-2 onward transmission. We found that compared to boosting with a Moderna mRNA systemic vaccine, a nanoparticle intranasal COVID-19 vaccine much more effectively prevents onward airborne transmission to naïve recipient hamsters. The protection was correlated with local mucosal antibody. Thus, a mucosal nanoparticle vaccine should be considered for preventing onward airborne transmission, a key public health necessity that has not been adequately studied.

Healthcare Resource Utilization Following Minimally Invasive Sacrocolpopexy: Impact of Concomitant Rectopexy.

INTRODUCTION AND HYPOTHESIS: Combined surgical procedures with sacrocolpopexy (SCP) and rectopexy (RP) are more commonly being performed for treatment of multicompartment pelvic organ prolapse. This study aimed to compare healthcare resource utilization (HRU) within 6 weeks following combined surgery (SCP-RP) versus SCP alone (SCP-only). We hypothesized that concomitant RP does not impact HRU. METHODS: A retrospective cohort study of patients who underwent minimally invasive SCP from 2017 to 2022 was conducted at a tertiary referral center. Patients were grouped based on the performance of concomitant RP. HRU was defined as a composite of unscheduled office visits, emergency department visits, and readmissions before the 6-week postoperative visit. HRU was compared in the SCP-RP and SCP-only groups. Multivariable regression analysis was performed to identify factors associated with HRU. RESULTS: There were 144 patients in the SCP-RP group and 405 patients in the SCP-only group. Patient characteristics were similar between the two groups, with the following exceptions: the SCP-RP group was older, more likely to have comorbid conditions, and live >60 miles from the hospital. Of the 549 patients, 183 (33.3%) had ≥1 HRU encounter within 6 weeks after surgery. However, there was no difference between the SCP-RP and SCP-only groups in composite HRU (34.0% vs 33.1%, p = 0.84). The most common reasons for HRU were pain, urinary tract infection symptoms, and wound issues. Concomitant mid-urethral sling was associated with a two-fold increased risk of HRU after surgery. CONCLUSIONS: One in 3 patients undergoing minimally invasive SCP had at least one unanticipated encounter within 6 weeks after surgery. Concomitant RP was not associated with increased postoperative HRU.

Urethral Bulking With Polyacrylamide Hydrogel Compared With Other Treatments for Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

Our objective was to perform a cost-effectiveness analysis comparing polyacrylamide hydrogel urethral bulking with other surgical and nonsurgical treatments for stress urinary incontinence (SUI). We created a cost-effectiveness analysis using TreeAge Pro, modeling eight SUI treatments. Treatment with midurethral sling (MUS) had the highest effectiveness (1.86 quality-adjusted life-years [QALYs]), followed by polyacrylamide hydrogel (1.82 QALYs), with a difference (Δ 0.02/year) less than the minimally important difference for utilities of 0.03 annually. When the proportion of polyacrylamide hydrogel urethral bulking procedures performed in the office setting is greater than 58%, polyacrylamide hydrogel is a cost-effective treatment for SUI, along with pessary, pelvic floor physical therapy, and MUS. Although MUS is more effective and, therefore, the preferred SUI treatment, polyacrylamide hydrogel is a reasonable alternative depending on patient preferences and treatment goals.

Patient Outcomes After Robotic Ventral Rectopexy With Sacrocolpopexy.

IMPORTANCE: As few studies exist examining postoperative functional outcomes in patients undergoing robotic sacrocolpopexy and ventral rectopexy, results from this study can help guide surgeons in counseling patients on their outcomes. OBJECTIVE: The aim of the study was to evaluate functional outcomes and overall postoperative satisfaction as measured by the Pelvic Floor Disability Index 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Patient Global Impression of Improvement Scale (PGI-I) in patients who underwent combined robotic ventral rectopexy and sacrocolpopexy for concomitant pelvic organ prolapse (POP) and rectal prolapse or intussusception (RP/I). METHODS: This was a retrospective cohort and survey study of patients with combined POP and RP/I who underwent the previously mentioned surgical repair between January 2018 and July 2021. Each patient was contacted to participate in a survey evaluating postoperative symptoms related bother, sexual function, and overall satisfaction using the PFDI-20, PISQ-12, and PGI-I. RESULTS: A total of 107 patients met study inclusion criteria with 67 patients completing the surveys. The mean age and body mass index were 63.7 ± 11.5 years and 25.0 ± 5.4, respectively. Of the patients, 19% had a prior RP repair and 23% had a prior POP repair. Rectal prolapse or intussusception recurrence was reported in 10.4% of patients and objective POP recurrence was found in 7.5% of patients. Sixty-seven patients (62%) completed the surveys. The median time to survey follow-up was 18 (8.8-51.8) months. At the time of survey, the mean PFDI-20 score was 95.7 ± 53.7. The mean PISQ-12 score for all patients was 32.8 ± 7.2 and the median PGI-I score was 2.0 (interquartile range, 1.0-3.0). CONCLUSIONS: In this cohort of patients who underwent a combined robotic ventral rectopexy and sacrocolpopexy, patient-reported postoperative symptom bother was low, sexual function was high, and their overall condition was much improved.

Vaginal hysteropexy compared with vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: A 5-year cost-effectiveness Markov model.

OBJECTIVE: Our objective was to perform a 5-year cost-effectiveness analysis of transvaginal hysteropexy (HP) via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) versus vaginal hysterectomy (VH) with apical suspension via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) for the treatment of uterine prolapse. DESIGN: A decision analytic model assessed the cost-effectiveness of the surgical intervention over a 5-year horizon. SETTING: This model was constructed using TreeAge® software. POPULATION OR SAMPLE: Healthy women undergoing surgery for uterine prolapse were modeled. METHODS: A Markov model was constructed to simulate the possible recurrence of prolapse. Recurrence rates, repeat surgery for surgical failures and complication rates were modeled. Base case, sensitivity analyses and probabilistic modeling were performed. MAIN OUTCOME MEASURES: The primary outcome was the incremental cost-effectiveness ratio (ICER) of <$100 000 per quality-adjusted life year (QALY). RESULTS: Using the available prolapse recurrence rates and repeat surgery rates in the literature, both HP-SS and HP-US are cost-effective at a willingness-to-pay (WTP) threshold of <$100 000 per QALY. The incremental cost-effectiveness ratio (ICER) for HP-US compared to HP-SS is $90 738.14, while VH-US and VH-SS are both dominated strategies. HP-US is the optimal cost-effective strategy but decays exponentially with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. The cost-effectiveness acceptability curve (CEAC) favors sacrospinous hysteropexy until reaching a WTP threshold between $90 000 and $100 000. CONCLUSION: Hysteropexy surgical strategies are cost-effective transvaginal surgical approaches for uterine prolapse. Vaginal hysterectomy with apical suspension becomes more cost-effective with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. Given the variability of prolapse recurrence rates in the literature, more comparative studies are needed to understand the cost-effectiveness relationship between these different surgical approaches.

Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Increased Grades of Rectal Intussusception: Role of Decline in Pelvic Floor Integrity and Association With Dyssynergic Defecation.

INTRODUCTION: The natural history of rectal intussusception (RI) is poorly understood. We hypothesized that decline in pelvic floor integrity and function leads to increasing RI grades. METHODS: Retrospective analysis of a registry of patients with defecatory disorders with high-resolution anorectal manometry and magnetic resonance defecography was performed. Association of risk factors on increasing RI grades was assessed using logistic regression. RESULTS: Analysis included a total of 238 women: 90 had no RI, 43 Oxford 1-2, 49 Oxford 3, and 56 Oxford 4-5. Age ( P = 0.017), vaginal delivery ( P = 0.008), and prior pelvic surgery ( P = 0.032) were associated with increased Oxford grades. Obstructive defecation symptoms and dyssynergic defecation were observed at relatively high rates across groups. Increased RI grades were associated with less anal relaxation at simulated defecation yet, higher rates of normal balloon expulsion ( P < 0.05), linked to diminished anal sphincter. Indeed, increased RI grades were associated with worsening fecal incontinence severity, attributed to higher rates of anal hypotension. Levator ani laxity, defined by increased levator hiatus length and its excessive descent at straining, was associated with increasing RI grades, independent of age, history of vaginal delivery, and pelvic surgeries and could independently predict increased RI grades. Concurrent anterior and posterior compartments, and visceral prolapse were associated with higher Oxford grades. DISCUSSION: Our data suggest that decline in pelvic floor integrity with abnormal levator ani laxity is associated with increased RI grades, a process that is independent of age, history of vaginal deliveries, and/or pelvic surgeries, and perhaps related to dyssynergic defecation.

Trends in Urogynecologic Surgery Among Obstetrics and Gynecology Residents From 2002 to 2022.

IMPORTANCE: The number of American women with a pelvic floor disorder is projected to increase from 28.1 million in 2010 to 43.8 million in 2050. OBJECTIVES: The objective of this study was to evaluate trends in the number of urogynecologic procedures performed by graduating obstetrics and gynecology residents and to compare variability in volume between residents in the 70th and 30th percentiles for logged cases. STUDY DESIGN: National case log measures for residents who graduated between 2003 and 2022 were reviewed. Mean case numbers and variability in case numbers were analyzed over time. RESULTS: Data were collected from a median of 1,216.5 residents (range, 1,090 to 1,427) annually. Mean number of vaginal hysterectomies logged per resident decreased by 46.4% from 2002/2003 to 2021/2022 ( P = 0.0007). Mean number of urogynecology procedures increased by 1,165.5% from 2002/2003 to 2007/2008 ( P = 0.0015). Mean number of incontinence and pelvic floor procedures (including cystoscopies) increased by 190.9% from 2002/2003 to 2011/2012 ( P = 0.0002). Mean number of incontinence and pelvic floor procedures (excluding cystoscopies) decreased by 39.7% from 2012/2013 to 2021/2022 ( P < 0.0001). Mean number of cystoscopies increased by 19.7% from 2012/2013 to 2021/2022 ( P < 0.0001). Ratios of cases logged by residents in the 70th percentile to those in the 30th percentile decreased for vaginal hysterectomies and cystoscopies ( P < 0.0001 and P = 0.0040, respectively). The ratio for incontinence and pelvic floor procedures (excluding cystoscopies) was 1.76 in 2012/2013 and 2.35 in 2021/2022 ( P = 0.2878). CONCLUSION: Resident surgical training in urogynecology is decreasing nationally.

Albumin Proteins as Delivery Vehicles for PFAS Contaminants into Respiratory Membranes.

Poly- and perfluoroalkyl substances (PFAS) are a family of chemicals that have been used in a wide range of commercial products. While their use is declining, the prevalence of PFAS, combined with their chemical longevity, ensures that detectable levels will remain in the environment for years to come. As such, there is a pressing need to understand how PFAS contaminants interact with other elements of the human exposome and the consequences of these interactions for human health. Using serum albumin as a model system, we show that proteins can bind PFAS contaminants and facilitate their incorporation into model pulmonary surfactant systems and lipid bilayers. Protein-mediated PFAS delivery significantly altered the structure and function of both model membrane systems, potentially contributing to respiratory dysfunction and airway diseases in vivo. These results provide valuable insights into the synergistic interaction between PFAS contaminants and other elements of the human exposome and their potential consequences for human health.

Surgical correction of the genital hiatus at the time of sacrocolpopexy - a 7-year Markov analysis: a cost-effectiveness analysis.

INTRODUCTION AND HYPOTHESIS: To perform a cost-effectiveness analysis of concurrent posterior repair performed at the time of laparoscopic hysterectomy with sacrocolpopexy over a 7-year time period. We hypothesize it is not cost-effective to perform a posterior colporrhaphy. METHODS: We used TreeAge Pro® to construct a decision model with Markov modeling to compare sacrocolpopexy with and without concurrent posterior repair (SCP and SCP+PR) over a time horizon of 7 years. Outcomes included probability and costs associated with prolapse recurrence, prolapse retreatment, and complications including rectal injury, rectovaginal hematoma requiring reoperation, and postoperative dyspareunia. Cost-effectiveness was defined as an incremental cost-effectiveness ratio (ICER) calculated as ∆ costs /∆ effectiveness and the willingness to pay (WTP) was set at $100,000/QALY. RESULTS: Our model showed that SCP was the dominant strategy, with lower costs (-$ 2681.06) and higher effectiveness (+0.10) compared to SCP+PR over the 7-year period. In two-way sensitivity analyses, we varied the probability of prolapse recurrence after both strategies. Our conclusions would only change if the probability of recurrence after SCP was at least 29.7% higher than after SCP+PR. When varying the probabilities of dyspareunia for both strategies, SCP+PR only became the dominant strategy if the probability of dyspareunia for SCP+PR was lower than the rate of SCP alone. CONCLUSIONS: In this 7-year Markov cost-effectiveness analysis, SCP without concurrent PR was the dominant strategy. SCP+PR costs more with lower effectiveness than SCP alone, due to higher surgical cost of SCP+PR and higher probability of dyspareunia after SCP+PR.

Medium-Term Outcomes of Conservative and Surgical Treatments for Stress Urinary Incontinence: A Medicare Claims Analysis: Developed by the AUGS Payment Reform Committee.

OBJECTIVE: This study aimed to evaluate the 3- to 5-year retreatment outcomes for conservatively and surgically treated urinary incontinence (UI) in a population of women 66 years and older. METHODS: This retrospective cohort study used 5% Medicare data to evaluate UI retreatment outcomes of women undergoing physical therapy (PT), pessary treatment, or sling surgery. The data set used inpatient, outpatient, and carrier claims from 2008 to 2016 in women 66 years and older with fee-for-service coverage. Treatment failure was defined as receiving another UI treatment (pessary, PT, sling, Burch urethropexy, or urethral bulking) or repeat sling. A secondary analysis was performed where additional treatment courses of PT or pessary were also considered a treatment failure. Survival analysis was used to evaluate the time from treatment initiation to retreatment. RESULTS: Between 2008 and 2013, 13,417 women were included with an index UI treatment, and follow-up continued through 2016. In this cohort, 41.4% received pessary treatment, 31.8% received PT, and 26.8% underwent sling surgery. In the primary analysis, pessaries had the lowest treatment failure rate compared with PT (P<0.001) and sling surgery (P<0.001; survival probability, 0.94 [pessary], 0.90 [PT], 0.88 [sling]). In the analysis where retreatment with PT or a pessary was considered a failure, sling surgery had the lowest retreatment rate (survival probability, 0.58 [pessary], 0.81 [PT], 0.88 [sling]; P<0.001 for all comparisons). CONCLUSIONS: In this administrative database analysis, there was a small but statistically significant difference in treatment failure among women undergoing sling surgery, PT, or pessary treatment, but pessary use was commonly associated with the need for repeat pessary fittings.

Sexual Function in Women at 6 and 12 Months After Obstetric Anal Sphincter Injury: Is Pelvic Floor Physical Therapy Associated With Improved Outcomes?

IMPORTANCE: Women with obstetric anal sphincter injury (OASI) are at increased risk of postpartum sexual dysfunction. Risk persists beyond 3 years after perineal trauma in up to half of patients with OASI. OBJECTIVES: The aims of this study were to determine if postpartum pelvic floor physical therapy (PFPT) is associated with improved sexual function after vaginal delivery with OASI and to describe sexual function in patients with OASI at 6 and 12 months postpartum. STUDY DESIGN: This is a retrospective cohort study of patients with OASI. Women were grouped according to PFPT attendance. The Postpartum Pelvic Floor and Birth Questionnaire (PPFBQ), which compares current sexual function to baseline prepregnancy sexual function, and the Female Sexual Function Index (FSFI) were administered at 6 and 12 months, respectively, to evaluate postpartum sexual function. RESULTS: Two hundred women were included. Sixty-four (32%) women attended PFPT; 136 (68%) did not attend PFPT. Patients reported worse-than-baseline sexual function at 6 months postpartum in the PPFBQ sexual activity domain, but the PFPT group had lower median score than the non-PFPT group (2.3 [2.0, 2.8] vs 2.7 [2.1, 3.1], P = 0.034), with scores <3.0 indicating worse-than-baseline functioning. The FSFI composite scores were similar between groups and showed 80.7% of the patients with OASI meeting the criteria for female sexual dysfunction at 12 months postpartum. Attendance of PFPT was not significantly associated with composite FSFI scores and most domains of PPFBQ. CONCLUSIONS: Attendance of PFPT did not significantly impact overall sexual function in OASI patients at 6 and 12 months postpartum. Sexual function is complex and may be more effectively addressed in the postpartum period using a multidimensional approach.

Nonhome Discharge in Patients Undergoing Pelvic Reconstructive Surgery: A National Analysis.

IMPORTANCE: Discharge to home after surgery has been recognized as a determinant of long-term survival and is a common concern in the elderly population. OBJECTIVE: The aim of the study was to determine the incidence and risk factors for nonhome discharge in patients undergoing major surgery for pelvic organ prolapse. STUDY DESIGN: We performed a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program Database from 2010 to 2018. We included patients who underwent sacrocolpopexy, vaginal colpopexy, and colpocleisis. We compared perioperative characteristics in patients who were discharged home versus those who were discharged to a nonhome location. Stepwise backward multivariate logistic regression was then used to control for confounding variables and identify independent predictors of nonhome discharge. RESULTS: A total of 38,012 patients were included in this study, 209 of whom experienced nonhome discharge (0.5%). Independent predictors of nonhome discharge included preoperative weight loss (adjusted odds ratio [aOR], 5.9; 95% confidence interval [CI], 1.3-27.5), dependent health care status (aOR, 5.0; 95% CI, 2.6-9.5), abdominal hysterectomy (aOR, 2.3; 95% CI, 1.4-3.7), American Society of Anesthesiologists class 3 or greater (aOR, 2.0; 95% CI, 1.5-2.7), age (aOR, 1.1; 95% CI, 1.05-1.09), operative time (aOR, 1.005; 95% CI, 1.003-1.006), laparoscopic hysterectomy (aOR, 0.6; 95% CI, 0.4-1.0), and laparoscopic sacrocolpopexy (aOR, 0.5; 95% CI, 0.3-0.8). CONCLUSIONS: In patients undergoing surgery for pelvic organ prolapse, nonhome discharge is associated with various indicators of frailty, including age, health care dependence, and certain comorbidities. An open surgical approach increases the risk of nonhome discharge, while a laparoscopic approach is associated with lower risk.

Characterization of Ebola Virus Mucosal Challenge Routes in Cynomolgus Macaques.

Zaïre ebolavirus (EBOV) causes Ebola virus disease (EVD), a devastating viral hemorrhagic fever in humans. Nonhuman primate (NHP) models of EVD traditionally use intramuscular infection with higher case fatality rates and reduced mean time-to-death compared to contact transmission typical of human cases of EVD. A cynomolgus macaque model of oral and conjunctival EBOV was used to further characterize the more clinically relevant contact transmission of EVD. NHPs challenged via the oral route had an overall 50% survival rate. NHPs challenged with a target dose of 1 × 102 PFU or 1 × 104 PFU of EBOV via the conjunctival route had 40% and 100% mortality, respectively. Classic signs of lethal EVD-like disease were observed in all NHPs that succumbed to EBOV infection including viremia, hematological abnormalities, clinical chemistries indicative of hepatic and renal disease, and histopathological findings. Evidence of EBOV viral persistence in the eye was observed in NHPs challenged via the conjunctival route. IMPORTANCE This study is the first to examine the Kikwit strain of EBOV, the most commonly used strain, in the gold-standard macaque model of infection. Additionally, this is the first description of the detection of virus in the vitreous fluid, an immune privileged site that has been proposed as a viral reservoir, following conjunctival challenge. The oral and conjunctival macaque challenge model of EVD described here more faithfully recapitulates the prodrome that has been reported for human EVD. This work paves the way for more advanced studies to model contact transmission of EVD, including early events in mucosal infection and immunity, as well as the establishment of persistent viral infection and the emergence from these reservoirs.

The Impact of Pelvic Floor Physical Therapy on Bladder and Bowel Function After Obstetric Anal Sphincter Injury.

IMPORTANCE: Women with obstetric anal sphincter injury (OASI) are at increased risk of pelvic floor disorders. No standard of care exists for management of pelvic floor dysfunction after OASI. OBJECTIVES: The aims of this study were to evaluate the impact of pelvic floor physical therapy (PFPT) on bladder and bowel function after OASI and to describe adherence to PFPT. STUDY DESIGN: A retrospective cohort study of women with OASI presenting at a postpartum care clinic from 2017 to 2021 was conducted. Women were grouped according to PFPT attendance. Urinary Distress Inventory 6 (UDI-6) and Fecal Incontinence Severity Index (FISI) were administered at baseline and 6 months. RESULTS: A total of 430 women with OASI presented to a postpartum care clinic, of which 137 (31.9%) attended PFPT, and 293 (68.1%) did not attend. Baseline and 6-month questionnaires were completed by 169 women: 52 (30.8%) in the PFPT group and 117 (69.2%) in the non-PFPT group. Baseline UDI-6 and FISI scores were higher in the PFPT group. Improvement in UDI-6 was not different between groups (-5.8 ± 14.9 vs -3.7 ± 10.8, P = 0.36). The non-PFPT group had greater worsening of FISI compared with PFPT group (9.8 ± 15.2 vs 1.1 ± 11.5, P < 0.001). Sixty-six percent (n = 136) of women referred to PFFT attended at least 1 session, of which 32.4% (n = 44) completed all sessions. Completely adherent women were referred to PFPT earlier (18.5 vs 28.5 days postpartum, P = 0.027). CONCLUSIONS: Women in both the PFPT and non-PFPT groups reported improvement in bladder leakage 6 months after OASI. Women who did not attend PFPT had significant worsening of bowel leakage. Early referral to PFPT in women with pelvic floor dysfunction following OASI should be considered.

Racial and socioeconomic disparities in cost and postoperative complications following sacrocolpopexy in a US National Inpatient Database.

PURPOSE: We sought to determine the association between socioeconomic factors, procedural costs, and postoperative complications among patients who underwent sacrocolpopexy. METHODS: The 2016-2017 US National Inpatient Sample from the Healthcare Cost and Utilization Project was used to identify females > 18 years of age with an ICD10 diagnosis code of apical prolapse who received open or laparoscopic/robotic sacrocolpopexy. We analyzed relationships between socioeconomic factors, procedural costs, and postoperative complications in these patients. Multivariate logistic and linear regressions were used to identify variables associated with increased complications and costs, respectively. RESULTS: We identified 4439 women who underwent sacrocolpopexy, of which 10.7% had complications. 34.6% of whites, 29.1% of Blacks, 29% of Hispanics, and 34% of Others underwent a laparoscopic/robotic procedure. Hispanic patients had the highest median charge associated with surgical admission for sacrocolpopexy at $51,768, followed by Other ($44,522), White ($43,471), and Black ($40,634) patients. Procedure being within an urban teaching hospital (+ $2602), laparoscopic/robotic (+ $6790), or in the West (+ $9729) were associated with a significantly higher median cost of surgical management. CONCLUSIONS: In women undergoing sacrocolpopexy, the protective factors against postoperative complications included private insurance status, a laparoscopic approach, and concurrent hysterectomy. Procedures held within an urban teaching hospital, conducted laparoscopically/robotically or in the West are associated with significantly higher costs of surgical management. Hispanic patients observe significantly higher procedure charges and costs, possibly resulting from the large number of this ethnic group living in the Western United States.

Evaluation of molnupiravir (EIDD-2801) efficacy against SARS-CoV-2 in the rhesus macaque model.

Molnupiravir (EIDD-2801) is a prodrug of a ribonucleoside analogue that is currently being used under a US FDA emergency use authorization for the treatment of mild to moderate COVID-19. We evaluated molnupiravir for efficacy as an oral treatment in the rhesus macaque model of SARS-CoV-2 infection. Twenty non-human primates (NHPs) were challenged with SARS-CoV-2 and treated with 75 mg/kg (n = 8) or 250 mg/kg (n = 8) of molnupiravir twice daily by oral gavage for 7 days. The NHPs were observed for 14 days post-challenge and monitored for clinical signs of disease. After challenge, all groups showed a trend toward increased respiration rates. Treatment with molnupiravir significantly reduced viral RNA levels in bronchoalveolar lavage (BAL) samples at Days 7 and 10. Considering the mild to moderate nature of SARS-CoV-2 infection in the rhesus macaque model, this study highlights the importance of monitoring the viral load in the lung as an indicator of pharmaceutical efficacy for COVID-19 treatments. Additionally, this study provides evidence of the efficacy of molnupiravir which supplements the current ongoing clinical trials of this drug.

Postoperative void trial failure and same-day discharge following apical pelvic organ prolapse surgery: a retrospective matched case-control study.

INTRODUCTION AND HYPOTHESIS: Robust data comparing the timing of voiding trials following prolapse surgery are lacking. Filling in these knowledge gaps would be helpful in counseling patients preoperatively about the concerns regarding same-day discharge. We aimed to compare the rate of a failed void trial after apical pelvic organ prolapse (POP) repair between patients who were discharged on the day of surgery versus those discharged on postoperative day 1. METHODS: This was a retrospective matched case-control study of women who underwent either a laparoscopic/robotic or transvaginal apical POP surgery with or without concurrent hysterectomy. Patients who were discharged on postoperative day 0 (POD0) were identified as cases and matched to control patients discharged on postoperative day 1 (POD1). Patients were matched 1:1 based on age and surgical approach. RESULTS: A total of 59 patients in each group met the inclusion criteria. Of the entire cohort, 34 (28.8%) patients failed their void trial, with no statistically significant difference between those who were discharged on POD0 versus POD1 (33.9% vs 23.7%, p=0.47). Patients who were discharged on POD0 were more likely to be diagnosed with a urinary tract infection (22.0% vs 8.4%, p=0.041) during the postoperative period. CONCLUSIONS: In patients undergoing surgery for apical prolapse, there was no difference in the rate of void trial failure in those who had a catheter removal on the day of surgery compared with those who experienced removal the following day.