Randomized Trial on Expectations and Pain Control Advancement in Surgery: The REPAIR Study.

IMPORTANCE: Following standardized preoperative education and adoption of shared decision making positively affects postoperative narcotic practices. OBJECTIVES: The aim of this study was to assess the impact of patient-centered preoperative education and shared decision making on the quantities of postoperative narcotics prescribed and consumed after urogynecologic surgery. STUDY DESIGN: Women undergoing urogynecologic surgery were randomized to "standard" (standard preoperative education, standard narcotic quantities at discharge) or "patient-centered" (patient-informed preoperative education, choice of narcotic quantities at discharge) groups. At discharge, the "standard" group received 30 (major surgery) or 12 (minor surgery) pills of 5-mg oxycodone. The "patient-centered" group chose 0 to 30 (major surgery) or 0 to 12 (minor surgery) pills. Outcomes included postoperative narcotics consumed and unused. Other outcomes included patient satisfaction/preparedness, return to activity, and pain interference. An intention-to-treat analysis was performed. RESULTS: The study enrolled 174 women; 154 were randomized and completed the major outcomes of interest (78 in the standard group, 76 in the patient-centered group). Narcotic consumption did not differ between groups (standard group: median of 3.5 pills, interquartile range [IQR] of [0, 8.25]; patient centered: median of 2, IQR of [0, 9.75]; P = 0.627). The patient-centered group had fewer narcotics prescribed ( P < 0.001) and unused ( P < 0.001), and chose a median of 20 pills (IQR [10, 30]) after a major surgical procedure and 12 pills (IQR [6, 12]) after a minor surgical procedure, with fewer unused narcotics (median difference, 9 pills; 95% confidence interval, 5-13; P < 0.001). There were no differences between groups' return to function, pain interference, and preparedness or satisfaction ( P > 0.05). CONCLUSIONS: Patient-centered education did not decrease narcotic consumption. Shared decision making did decrease prescribed and unused narcotics. Shared decision making in narcotic prescribing is feasible and may improve postoperative prescribing practices.

Risk Factors for De Novo Overactive Bladder After Midurethral Sling.

IMPORTANCE: The low incidence of de novo overactive bladder (OAB) symptoms after a midurethral sling (MUS) procedure better informs preoperative counseling. OBJECTIVE: The study aimed to measure the incidence and risk factors for de novo OAB after MUS. STUDY DESIGN: This was a retrospective cohort study of de novo OAB symptoms in patients who underwent MUS surgery in a health maintenance organization between January 1, 2008, and September 30, 2016. Patients were identified using Current Procedural Terminology codes for MUS and International Classification of Diseases, Tenth Revision codes for urinary urgency, frequency, nocturia, OAB, and urgency urinary incontinence (UUI). The cohort of patients was identified by the absence of these International Classification of Diseases, Tenth Revision codes 12 months preoperatively and the presence of these codes within 6 months after surgery. This cohort was used to calculate the rate of de novo OAB after MUS surgery. Clinical and demographic factors were abstracted. Statistical analysis was performed using descriptive, χ2 , simple logistic, and multiple logistic regression. RESULTS: During the study period, 13,893 patients underwent MUS surgery and 6,634 met the inclusion criteria. The mean age was 56.9 years, mean parity was 2.76, and mean body mass index was 28.9 (calculated as weight in kilograms divided by height in meters squared). Of these, 410 (6.1%) developed de novo OAB within 12 months. The most common symptoms were urgency (65.4%), UUI (42.2%), and frequency (19.8%). On multivariable regression modeling, de novo urgency and UUI were not associated with concurrent surgery ( P < 0.05). Increasing age and body mass index were associated with an increased risk of nocturia ( P < 0.05). CONCLUSIONS: The incidence of de novo OAB after MUS surgery was 6.1%. This aligns with current literature and critically informs preoperative counseling for MUS surgery.

Factors Associated With Increased Estimated Blood Loss and Factors Associated With Utilization of Type and Screen in Benign Gynecology: A Retrospective Chart Review.

IMPORTANCE: There is minimal literature discussing factors associated with increased estimated blood loss (EBL) or transfusion in gynecologic surgery in tertiary academic centers. OBJECTIVE: The aim of the study was to determine factors associated with transfusion and increased blood loss during gynecologic surgery. STUDY DESIGN: This retrospective cohort investigated patients undergoing benign gynecologic procedures at a tertiary medical center. We excluded women undergoing surgery for known or suspected malignancy, emergent surgery, obstetrical procedures, or cases with another surgical specialty. Patient age, body mass index, American Society of Anesthesiologists class, medical history, EBL, arterial line placement, preoperative laboratory studies, and transfusion receipt for up to 6 weeks postoperatively were extracted. The primary outcome was transfusion within 6 weeks of surgery; risk factors for high blood loss (EBL >500 mL) and transfusion were explored. RESULTS: Nine hundred seventy-five surgical procedures were included (59% vaginal, 36% laparoscopic, 4% robotic). Median EBL was 50 mL (interquartile range, 10-100 mL). Estimated blood loss increased with duration of surgery (P < 0.01). Transfusions were more likely to occur during open procedures (13%) compared with vaginal (2%), laparoscopic (2%), or robotic (3%). Arterial line placement (relative risk [RR], 11.8; 95% confidence interval [CI], 5.3-26.1) and additional intravenous placement (RR, 6.0; 95% CI, 2.6 to 13.7) were associated with transfusion. Vaginal surgery (RR, 0.13; 95% CI, 0.05 to 0.32) and urogynecologic procedures (RR, 0.1; CI, 0.01-0.7) were associated with reduced risk of needing transfusion. CONCLUSIONS: Most benign gynecologic surgical procedures have minimal blood loss. Patients undergoing surgery through minimally invasive routes or urogynecologic procedures are at further decreased risk of transfusion.

Female Pelvic Fistulae.

Female pelvic fistulae are a pathologic connection between the urinary or gastrointestinal tract and the genital tract. Although this condition has been present for millennia, successful surgical treatments have only been described for the past few hundred years. In developed nations, the most common cause of genitourinary fistulae is benign gynecologic surgery, but worldwide it is obstetric trauma. Fistulae management is rooted in surgical intervention with the highest probability of success associated with the first repair.

A lasting impression: telemedicine in urogynecology during the coronavirus disease 2019 pandemic.

PURPOSE OF REVIEW: Amidst the worldwide coronavirus disease 2019 pandemic, a new medical landscape revolving around telemedicine has arisen. The purpose of this review is to describe and analyze current urogynecologic guidelines for optimizing usage of telemedicine when treating women with pelvic floor disorders. RECENT FINDINGS: Women managed by urogynecologists are on average older, and hence more likely to have comorbidities that make them susceptible to developing coronavirus disease 2019 with severe symptoms. Telemedicine is key in minimizing exposure without sacrificing treatments and quality of life. Recent studies published prior to the pandemic helped set the stage for successful components of virtual care. Nonsurgical options are crucial to beginning a treatment plan while elective surgeries are still restricted in many hospitals. Medication management and innovative technology, such as smart telephone applications, play a prominent role. The comprehensive literature review discussed here describes the degree of evidence supporting each management option, while also noting the limitations of telemedicine. SUMMARY: Telemedicine has opened a new door for the field of urogynecology allowing for continued safe, evidence-based care. The pandemic culture has tipped the balance away from surgery and toward nonsurgical treatments while attempting not to sacrifice outcomes or quality of care.

A ruptured vulvar labial artery pseudoaneurysm causes a secondary postpartum hemorrhage: A case report.

BACKGROUND: Postpartum hemorrhage is the most common cause of maternal morbidity in the United States. However, secondary postpartum hemorrhage is rare and includes pseudoaneurysms, which represent only 3.3% of all cases of secondary postpartum hemorrhage. Vulvar labial artery pseudoaneurysm had never been reported in the literature. CASE: This is a case of ruptured vulvar labial pseudoaneurysm leading to secondary postpartum hemorrhage. Computerized tomography angiography showed it to be located in a distal branch of the vulvar labial artery. This location is unique, although there are reported cases of pseudoaneurysms in the uterine artery. The patient was successfully treated with arterial embolization. CONCLUSION: Recognition of a ruptured pseudoaneurysm as the cause of postpartum hemorrhage allows for its proper management by arterial embolization.

The Ecstacy of Gold: Patent Expirations for Trastuzumab, Bevacizumab, Rituximab, and Cetuximab.

OBJECTIVE: Fully humanized monoclonal antibodies have revolutionized the treatment of many solid tumors, including ovarian, lung, colorectal, and breast cancer. Among the most widely used monoclonal antibodies in clinical oncology are cetuximab, trastuzumab, rituximab, and bevacizumab. METHODS: This is a review article focusing on the drug patents for cetuximab, trastuzumab, rituximab, and bevacizumab. RESULTS: These four monoclonal antibodies are used in both first and second line treatment regimens for multiple common malignancies. With recent patent expirations, pharmaceutical companies involved in biosimilar manufacture are looking to establish ownership over these financial monopolies. CONCLUSION: This article will review these four notable monoclonal antibodies, their role in clinical oncology, and the drug patents that are nearing expiration. There are currently only two biosimilars approved in the United States: the trastuzumab biosimilar trastuzumab-dkst (Ogivri) and the bevacizumab biosimilar bevacizumab-awwb (Mvasi). In Europe, SB3, a trastuzumab biosimilar, is approved for use as well as two rituzimab biosimilars, truxima and rixathon.

Cardiophrenic lymph node metastasis in low-grade serous ovarian adenocarcinoma.

•Cardiophrenic lymph node metastasis in low-grade ovarian carcinoma is rare.•Two cases presented here identify clinical strategies needing further attention.•Low-grade disease is treated with surgery given high chemotherapeutic resistance.•Preoperative awareness of lymph node metastasis allows for optimal debulking.•Identifying radiologic evidence of distant metastasis improves patient outcomes.

A review of HER2-targeted therapy in breast and ovarian cancer: lessons from antiquity - CLEOPATRA and PENELOPE.

Although breast and ovarian cancer have notable distinctions, there may exist parallel pathways that can be exploited for therapeutic gain. For example, the therapeutic arena in breast cancer has benefited greatly from available endocrine therapies as well as novel drugs designed to target the HER2 receptor, including trastuzumab, lapatinib, T-DM1 and pertuzumab. CLEOPATRA, a Phase III randomized clinical trial studying pertuzumab in women with HER2-amplified metastatic breast cancer, was practice-changing in 2014. Its counterpart, the Phase III randomized PENELOPE trial, was activated following promising Phase II data and studied pertuzumab in an enriched ovarian cancer patient population with low HER3 mRNA. This review will trace the development of anti-HER2 therapies in breast and ovarian cancer.

ATP Binding Cassette C1 (ABCC1/MRP1)-mediated drug efflux contributes to disease progression in T-lineage acute lymphoblastic leukemia.

PURPOSE: In acute lymphoblastic leukemia (ALL), multidrug resistance is often mediated by ATPase Binding Cassette (ABC) proteins, which principally involve ABCB1 (multidrug resistance 1, MDR1) and ABCC1 (multidrug resistance protein 1, MRP1). However, direct comparisons between the differential effects of ABCB1 and ABCC1 have been difficult, since identical cell lines with differential expression of these transporters have not been developed. EXPERIMENTAL DESIGN: In this study, we developed and compared the biological profiles of Jurkat cell lines that selectively over-expressed ABCB1 and ABCC1. Vincristine (VCR) plays an important role in the treatment of T-lineage ALL (T-ALL), and is often the first drug given to newly-diagnosed patients. Because of its importance in treatment, we provided escalating, sub-lethal doses of VCR to Jurkat cells, and extended our observations to expression profiling of newly diagnosed patients with T-ALL. RESULTS: We found that VCR-resistant cells over-expressed ABCC1 nearly 30-fold. The calcein AM assay confirmed that VCR-resistant cells actively extruded VCR, and that ABCC1-mediated drug resistance conferred a different spectrum of multidrug resistance than other T-ALL induction agents. siRNA experiments that blocked ABCC1 export confirmed that VCR resistance could be reversed in vitro. Analyses of T-lymphoblasts obtained from 92 newly diagnosed T-ALL patients treated on Children's Oncology Group Phase III studies 8704/9404 showed that induction failure could be explained in all but one case by the over-expression of ABCB1 or ABCC1. CONCLUSIONS: Taken together, these results suggest that over-expression of ABC transporters plays a contributing role in mediating treatment failure in T-ALL, and underscore the need to employ alternate treatment approaches in patients for whom induction failed or for those with relapsed disease.