Sexual and Urinary Health among Women following Bariatric Surgery.

PURPOSE: Women with obesity are more likely to experience bothersome urinary and sexual symptoms, but the long-term effect of metabolic and bariatric surgery (MBS) on these outcomes is poorly understood. We aimed to describe how MBS longitudinally impacted women's urinary and sexual health. METHODS: Patients who underwent MBS at the University of California, San Francisco Medical Center (UCSF) between 2009 and 2021 participated in a survey examining sexual health, pelvic organ prolapse (POP), and urinary health using three validated questionnaires: a modified version of the Female Sexual Function Index (FSFI), the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), and the Urinary Distress Inventory 6 (UDI-6). All questions asked referenced two time points: before surgery and at the time of survey. Logistic regression identified predictors of symptom improvement. RESULTS: Of 162 participants contacted, 118 (73%) had complete survey data. Mean body mass index (BMI) decreased from 52.4 ± 12.6 to 36.3 ± 9.7 kg/m2 (p < 0.01) with an average follow-up of 6 years. The mean UDI-6 score amongst women was 24 ± 24 prior to MBS and 24 ± 26 at the time of survey administration (p = 0.458). Mean modified FSFI scores amongst women were 15 ± 5 prior to surgery and 14 ± 7 at the time of survey administration (p = 0.005). The overall mean POPDI-6 score amongst women was 13 ± 15 prior to surgery and 9 ± 14 at the time of survey administration (p = 0.056). CONCLUSION: Women who underwent MBS reported a high rate of sexual and urological dysfunction that did not improve longitudinally, despite significant weight loss.

Patient decision-making for surgical treatment of post-prostatectomy stress urinary incontinence: a mixed-methods exploratory pilot study.

Background: Male stress urinary incontinence (SUI) is a known complication following surgical intervention on the prostate, particularly following surgery for prostate cancer. Effective surgical treatments for SUI include artificial urinary sphincter (AUS) and male urethral sling. Prior data suggest that men may forego available treatment despite bothersome symptoms. The objective was to explore how men who underwent surgical correction for post-prostatectomy SUI navigated SUI treatment decisions. Methods: Mixed method study was employed. Semi-structured interviews, participant surveys and objective clinical assessment of SUI were performed among a group of men living with incontinence after prostate cancer surgery who underwent surgery for SUI at the University of California in 2017. Results: Eleven men were interviewed after consultation for SUI and all had complete quantitative clinical data. Surgery for SUI included AUS (n=8) and sling (n=3). There was a decrease in pads per day from 3.2 to 0.9 and no major complications. Most patients found that the impact on activities and their treating urologist were of great importance. Sexual and relationships played a variable role with some participants ranking these as "great deal of influence" and others "little or no influence". Participants who underwent AUS were more likely to cite a higher importance on "being very dry" in choosing that surgery while sling patients had more variable ranking of important factors. Participants found a variety of inputs helpful in hearing information about SUI treatment options. Conclusions: Among a group of 11 men who underwent surgical correction for post-prostatectomy SUI, there were identifiable themes on how men make decisions, evaluate quality of life (QoL) changes and approach treatment options. Men value more than being dry with measures of individual success that can include sexual and relationship health. Furthermore the role of the Urologist remains crucial as patients relied heavily on input and discussion with their Urologist to assist in treatment decisions. These findings can be used to inform future studies of the experience of men with SUI.

Utility and Outcome of Angioembolization for High-Grade Renal Trauma Management in a Large Hospital-Based Trauma Registry.

PURPOSE: We evaluated angioembolization (AE) use for high-grade renal trauma (HGRT) management and compared AE vs surgical repair (SR) in requiring nephrectomy. MATERIALS AND METHODS: Using National Trauma Data Bank® 2013-2018, we identified patients with HGRT who underwent AE or SR as initial management. Therapy failure was defined as performing subsequent nephrectomy, partial nephrectomy, SR or AE. Logistic regression was performed to assess the association between intervention type (AE vs SR) and nephrectomy. Analysis was repeated in a propensity score-matched cohort constructed by matching AE to SR patients on American Association for the Surgery of Trauma (AAST) grade, injury mechanism (blunt vs penetrating) and hemodynamic instability (systolic blood pressure <90 mmHg). RESULTS: There were 266 patients in the AE group and 215 in the SR group. Median age was 29.5 years and 212 patients (44.1%) had penetrating injuries. AE was successful in 94.2% and 85.3% of grade IV and V injuries, respectively, whereas SR was successful in 82.1% and 56%, respectively. Grade V injury was associated with AE failure in the adjusted analysis (OR 3.55, 95% CI 1.22-10.2, p=0.02). Nephrectomy was less likely to be performed after AE vs after SR in HGRT (6.4% vs 17.2%, p=0.01), AAST grade IV (4.2% vs 13.7%, p=0.001) and AAST grade V (12% vs 44%, p=0.001). The matched cohort comprised 528 patients. In post-match regression, AE, compared to SR, was associated with lower odds of nephrectomy (OR 0.18, 95% CI 0.04-0.70, p=0.013). CONCLUSIONS: AE achieved superior kidney salvage compared to SR in this observational cohort. These results inform both clinical practice and future prospective trials.

Predictors of Regret among Older Men after Stress Urinary Incontinence Treatment Decisions.

PURPOSE: When seeking treatment for male stress urinary incontinence (mSUI), patients are faced with weighing complex risks and benefits in making treatment decisions within their individual context. We sought to quantify the frequency of decisional regret among this population and to determine factors associated with regret. MATERIALS AND METHODS: A cohort of 130 males aged ≥65 years seen for initial mSUI consultation at the University of California, San Francisco Medical Center and the San Francisco Veterans Affairs Medical Center between June 2015 and March 2020 was developed. Using retrospective chart review and telephone interviews, we ascertained decisional regret as well as other patient-, disease- and treatment-related characteristics. Decisional regret was analyzed by treatment type and patient-, disease- and treatment-related factors. Multivariable logistic regression models were built to examine the factors most associated with decisional regret. RESULTS: Among the entire cohort, 22% reported moderate to severe decisional regret. Regret was highest among those electing conservative management, with 34.7% having decisional regret (vs with surgery: 8.3% sling, 8.2% sphincter; p <0.001). In multivariable analysis, depression, lower rating of shared decision making and higher current incontinence scores were significantly associated with decisional regret. CONCLUSIONS: Recognition of depression, improved efforts at shared decision making and more individualized treatment counseling have the potential to improve patient satisfaction with treatment choice. In addition, given high levels of regret among those electing conservative treatment, we may be underutilizing mSUI surgery in this population.

Understanding the Health Characteristics and Treatment Choices of Older Men with Stress Urinary Incontinence.

OBJECTIVE: To describe the health characteristics and current treatment choices of male stress urinary incontinence (mSUI) patients to inform patient-centered decision-making. METHODS: We identified a cohort of mSUI patients aged ≥65 at UCSF and San Francisco VA. Using retrospective chart review and telephone interviews, we ascertained demographics, incontinence characteristics, Charlson Comorbidity Index (score ≥ 4 indicates significant morbidity), frailty with Timed Up and Go (TUG) test, functional dependence with activities of daily living (ADL), calculated life expectancy, and assessed mental health and quality of life (QOL). Bivariate analysis evaluated associations between subject characteristics and ultimate treatment type (conservative vs surgery; sling vs sphincter). Logistic multivariable models evaluating treatment choice were also constructed. RESULTS: The 130 participants had a mean age of 75 and a mean incontinence score of 14.2 representing moderately bothersome incontinence. Nearly 80% had significant morbidity, three-quarters had >50% 10-year mortality risk, 10% needed help with 1 + ADL and 22% had a TUG >10 seconds indicating frailty. The mean physical and mental QOL scores were similar to the general population. Anxiety and depression were reported by 3.9% and 10%. In univariate and multivariable analysis, only incontinence characteristics were associated with conservative vs surgical treatment choice (P < .01). CONCLUSION: Multi-morbidity, functional dependence, frailty, and limited life expectancy are common among older men with mSUI, yet current treatment choices appear to be driven by incontinence characteristics. As such, mSUI surgery should be considered among men across the spectrum of health and life expectancy.

Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers.

A metastatic cancer diagnosis is associated with high levels of distress in patients and caregivers. Mindfulness interventions can reduce distress and improve quality of life in cancer patients. However, standard mindfulness training relies on in-person instruction, which is often not practical for either patients receiving chemotherapy or their caregivers. In the Being Present single arm pilot study, we designed and tested an 8-week audio-based mindfulness meditation program for patients with metastatic colorectal cancer receiving chemotherapy with or without a participating caregiver. The study accrued 33 of 74 (45%) eligible patients consenting together with 20 family caregivers (53 participants total) within nine months. Forty-one participants were evaluable (77%); 10 of 12 cases of attrition were attributable to hospitalization or death. Median participant age was 51 (range 21-78 years); 38% were men. Baseline levels of distress were similar in patients and caregivers. The top reasons for participation cited in pre-intervention interviews were to increase relaxation/calm, improve mood/emotions, and reduce stress/anxiety. In measures of adherence, 59% of responses to weekly texts asking: "Have you practiced today?" were "Yes" and 59% of interviewees reported practicing >50% of the time. Compared to baseline, post-intervention surveys demonstrated significantly reduced distress (p = 0.01) and anxiety (p = 0.03); as well as increased non-reactivity (p<0.01), and feeling at peace (p<0.01). Post-intervention qualitative interviews, where 71% of participants reported benefit, were consistent with quantitative findings. In the interviews, participants spontaneously described reduced stress/anxiety and increased relaxation/calm. Benefits appeared to be accentuated in patient-caregiver pairs as compared to unpaired patients. Seventy-nine percent of participants reported plans for continued practice after study completion. We conclude that the Being Present audio-based mindfulness meditation program is of interest to, feasible, and acceptable for patients with metastatic colorectal cancer and caregivers, with initial evidence of efficacy. These results will guide plans for a follow-up study. TRIAL REGISTRATION: ClinicalTrials.gov NCT02423720.

Survival outcomes in pediatric recurrent high-grade glioma: results of a 20-year systematic review and meta-analysis.

Recurrent pediatric high-grade glioma is a leading cause of cancer-related death in children. We report results of a systematic review and meta-analysis investigating survival outcome in pediatric patients with recurrent high-grade glioma over the last 20 years. MEDLINE/PubMed, EMBASE, Web of Science and Cochrane Review databases were searched for relevant studies reporting on survival outcomes for pediatric patients with recurrent high-grade glioma treated between 1996 and 2016. Progression-free survival (PFS) and overall survival (OS) were calculated cumulatively over all studies, by therapy subgroup, and by decade of treatment. Random effects models were used to control for heterogeneity as measured by the I2 statistic. A total of 17 studies across 4 treatment strategies were included. Eleven investigated traditional chemotherapy, 1 investigated targeted therapy, 3 investigated immunotherapy, and 2 investigated radiotherapy. A total of 129 patients were included with a median age of 10.0 years. Cumulative PFS was 3.5 months (95% CI 2.1-5.0). Cumulative OS was 5.6 months (95% CI 3.9-7.3). OS was 4.0 months (95% CI 1.9-6.1) using traditional chemotherapy, 9.3 months using targeted therapies (95% CI 5.4-13), 6.9 months using immunotherapy (95% CI 2.1-12), and 14 months using reirradiation (95% CI 2.8-25). OS between 1996 and 2006 was 4.2 months (95% CI 2.1-6.2) compared to 8.5 months (95% CI 5.6-11) after 2006. Pediatric patients with recurrent high-grade glioma suffer from poor PFS and OS, regardless of therapy. There may be a trend towards improved OS in the last decade.

Continuous Non-invasive finger cuff CareTaker® comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgery.

BACKGROUND: Despite increased interest in non-invasive arterial pressure monitoring, the majority of commercially available technologies have failed to satisfy the limits established for the validation of automatic arterial pressure monitoring by the Association for the Advancement of Medical Instrumentation (AAMI). According to the ANSI/AAMI/ISO 81060-2:2013 standards, the group-average accuracy and precision are defined as acceptable if bias is not greater than 5 mmHg and standard deviation is not greater than 8 mmHg. In this study, these standards are used to evaluate the CareTaker® (CT) device, a device measuring continuous non-invasive blood pressure via a pulse contour algorithm called Pulse Decomposition Analysis. METHODS: A convenience sample of 24 patients scheduled for major abdominal surgery were consented to participate in this IRB approved pilot study. Each patient was monitored with a radial arterial catheter and CT using a finger cuff applied to the contralateral thumb. Hemodynamic variables were measured and analyzed from both devices for the first thirty minutes of the surgical procedure including the induction of anesthesia. The mean arterial pressure (MAP), systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements, a Bland-Altman analysis, and polar and 4Q plots were created. RESULTS: The correlation of systolic, diastolic, and mean arterial pressures were 0.92, 0.86, 0.91, respectively (p < 0.0001 for all the comparisons). The Bland-Altman comparison yielded a bias (as measured by overall mean difference) of -0.57, -2.52, 1.01 mmHg for systolic, diastolic, and mean arterial pressures, respectively with a standard deviation of 7.34, 6.47, 5.33 mmHg for systolic, diastolic, and mean arterial pressures, respectively (p < 0.001 for all comparisons). The polar plot indicates little bias between the two methods (90%/95% CI at 31.5°/52°, respectively, overall bias = 1.5°) with only a small percentage of points outside these lines. The 4Q plot indicates good concordance and no bias between the methods. CONCLUSIONS: In this study, blood pressure measured using the non-invasive CT device was shown to correlate well with the arterial catheter measurements. Larger studies are needed to confirm these results in more varied settings. Most patients exhibited very good agreement between methods. Results were well within the limits established for the validation of automatic arterial pressure monitoring by the AAMI.

Differential Radiographic Appearance of BRAF V600E-Mutant Metastatic Colorectal Cancer in Patients Matched by Primary Tumor Location.

BACKGROUND: BRAF-mutant metastatic colorectal cancers (mCRCs) share many clinicopathologic features with right-sided colon tumors, including frequent peritoneal involvement. Because of the poorer outcomes associated with BRAF mutations, early enrollment in clinical trials has been encouraged. However, the use of standard eligibility and assessment criteria, such as measurable disease, has anecdotally impeded patient accrual and restricted appraisal of treatment response. We investigated whether the presence of a BRAF V600E mutation is differentially associated with sites and appearance of metastatic disease in patients matched by primary tumor location. METHODS: A total of 40 patients with BRAF-mutant mCRC were matched to 80 patients with BRAF wild-type mCRC by location of primary tumor (right or left colon; rectum), sex, and age. Associations between BRAF mutation status and clinicopathologic characteristics and metastatic sites were analyzed using proportion tests. Survival was summarized with Kaplan-Meier and Cox regression methods. RESULTS: The distribution of primary tumor locations was: 60% right colon, 30% left colon, and 10% rectum. Compared with BRAF wild-type tumors, BRAF-mutant tumors more commonly associated with peritoneal metastases (50% vs 31%; P=.045) and ascites (50% vs 24%; P=.0038). In patients with left colon primaries, BRAF mutations were associated with more frequent ascites (58% vs 12%; P=.0038) and less frequent liver metastases (42% vs 79%; P=.024). Among patients with right colon primaries, no significant difference in sites of disease by BRAF mutation status was observed. Disease was not measurable by RECIST 1.1 in 24% of patients with right-sided primary tumors, irrespective of BRAF mutation status. In the BRAF-mutated cohort, ascites correlated unfavorably with survival (hazard ratio, 2.35; 95% CI, 1.14, 4.83; P=.02). CONCLUSIONS: Greater frequency of ascites and peritoneal metastases, which pose challenges for RECIST 1.1 interpretation of therapeutic outcomes, are seen with BRAF-mutant mCRC, even when patients are matched for primary tumor location.

Efficacy and safety of erythropoiesis-stimulating proteins in myelodysplastic syndrome: a systematic review and meta-analysis.

OBJECTIVE: The objective was to assess the efficacy and safety of erythropoiesis-stimulating proteins (ESPs) in anemia of myelodysplastic syndrome (MDS). METHOD: A systematic review and meta-analysis was conducted covering English-language studies published from 1980 to December 2005. RESULTS: Fifty-nine studies qualified: five controlled trials (n = 354), all epoetin versus control (EvC); 51 epoetin single-arm studies (n = 1,650); and three darbepoetin single-arm studies (n = 102). In the EvC studies, epoetin patients demonstrated a significant advantage over controls in terms of hemoglobin (Hb) response (odds ratio, 5.2; 95% confidence interval, 2.5-10.8). Hb response was 48.1% in single-arm darbepoetin studies, 32.1% in epoetin single-arm studies, and 27.3% in EvC studies. Major Hb response averaged 38.8% in darbepoetin studies, 24.5% in epoetin single-arm studies, and 11.4% in EvC studies. Stratified analyses suggest that lower baseline erythropoietin levels, longer treatment durations, and concurrent iron may be associated with greater Hb response to ESPs. None of the analyzable predictors of Hb response (gender, baseline Hb, ESP type, and ESP duration) were significant in meta-regression analyses. In the few studies with quality-of-life measures, ESP groups attained a pre-post change (Functional Assessment of Cancer Therapy - Fatigue) that exceeded minimum clinically important differences. Selected adverse event rates did not differ between the epoetin and darbepoetin groups. CONCLUSION: Published studies suggest that ESPs are efficacious in anemia of MDS. Hb response appears higher in darbepoetin patients than in epoetin patients, and safety appears comparable, but darbepoetin data are sparse, and there are as yet no direct comparison studies.

Clinical benefits and risks associated with epoetin and darbepoetin in patients with chemotherapy-induced anemia: a systematic review of the literature.

BACKGROUND: Erythropoiesis-stimulating proteins (ESPs) are indicated for the treatment of chemotherapy-induced anemia (CIA). Evidence-based guidelines and systematic reviews of the management of CIA do not yet include all currently approved ESPs or all of the clinically relevant benefits and risks of ESPs. OBJECTIVES: The aims of this work were to provide up-to-date assessments of the clinical efficacy and effectiveness (ie, transfusions and quality-of-life [QoL] benefits) and safety (ie, risk of venous thromboembolism [VTE] and all-cause or treatment-associated death) of epoetin-alfa, epoetin-beta, and darbepoetin-alfa for the treatment of CIA in cancer patients with hemoglobin<11 g/dL. We also considered the impact of differences in study design, patients, and treatments on the results. METHODS: A systematic review of the literature was performed to identify and analyze English-language studies (controlled trials and prospective uncontrolled studies with >or=300 patients) published between 1980 and July 2005. The databases searched were MEDLINE and the Cochrane Library. Relevant abstracts from the last 2 annual meetings of the American Society of Clinical Oncology, American Society of Hematology, and European Society for Medical Oncology were also included. Studies were selected, using predefined eligibility criteria. Two reviewers had to agree on all included and excluded studies, and on all data extracted from each accepted study before they were entered into a relational database. Meta-analyses were performed to quantify benefit and risk outcomes. RESULTS: In total, 40 studies including 21,378 patients were eligible for analysis. Each ESP was found to have efficacy relative to standard care or placebo. The odds ratio (OR) for transfusions in studies of epoetin versus controls was 0.44 (95% CI, 0.35-0.55) and of darbepoetin versus controls was 0.41 (95% CI, 0.31-0.55). Patients receiving ESPs experienced a significant improvement in QoL; the mean difference in Functional Assessment of Cancer Therapy-Fatigue score for ESPs versus controls was 0.23 (95% CI, 0.10-0.36; P=0.001). The frequency of VTE and death was not significantly different between ESPs and control (VTE OR, 1.41 [95% CI, 0.81-2.47]; all-cause mortality OR, 1.00 [95% CI, 0.69-1.44]). CONCLUSIONS: This analysis of key clinical benefits and risks of epoetin and darbepoetin in the treatment of CIA found no clinically relevant differences between these drugs.