Incidence of traffic light labelling on noncommunicable diseases: a roadmap for achieving sustainable development.

The production and diversity of the supply of food products has grown exponentially in recent decades, along with the increase in cardiovascular diseases associated with poor diet. Among the factors, one of the most important is the lack of information for the consumer when purchasing. The present work evaluates the impact of implementing the traffic light labelling of foods in reducing deaths due to Noncommunicable Diseases (NCD). Econometric techniques of two-way effects panel data from 21 Ecuadorian provinces taken from official sources for the analysis period 2010-2019. For Ecuador, a favourable impact was found in the reduction of the NCD mortality rate, especially in the last three years; in 2017, it was reduced by 0.129%, in 2018 by 0.305%, and in 2019 by 0.289%. An implication of economic policy is the advertising regulation of products that may affect health, strengthening surveillance and sanctioning companies that fail to comply with the regulation.

Initial Chemotherapy for Locally Advanced and Metastatic NUT Carcinoma.

INTRODUCTION: NUT carcinoma (NC) is an underdiagnosed and aggressive poorly differentiated or squamous cell cancer. A subset of NC is sensitive to chemotherapy, but the optimal regimen is unknown. Experts have recommended platinum- and ifosfamide-based therapy based on case reports. METHODS: Patients with pathologically confirmed NC with known survival outcomes after chemotherapy and consented to participate in a worldwide registry were studied. Results were summarized using descriptive methods. RESULTS: The study included 118 patients with NC. Median age was 34 (range: 1-82) years, 39% were women, and 61% harbored a BRD4::NUTM1 fusion. Patients received platinum (74%) or ifosfamide (26%, including regimens with both, 13%). Of 62 patients with nonmetastatic disease, 40% had a thoracic primary. Compared with platinum-based chemotherapy, patients who received ifosfamide-based chemotherapy had nominally higher progression-free survival (12 mo: 59% [95% CI: 32-87] versus 37% [95% CI: 22-52], hazard ratio = 0.68 [0.32, 1.42], p = 0.3) but not overall survival (OS). Among the 56 patients with metastatic disease, 80% had a thoracic primary. Ifosfamide had an objective response rate (ORR) of 75% (six of eight) and platinum had an ORR of 31% (11 of 36). Nevertheless, there was no difference in progression-free survival or OS. The 3-year OS of the entire cohort was 19% (95% CI: 10%-28%). Of the 11 patients alive greater than 3 years, all presented with nonmetastatic and operable or resectable disease. CONCLUSION: There is a numerically higher ORR for ifosfamide-based therapy compared with platinum-based therapy, with limited durability. OS at 3 years is only 19%, and development of effective therapies is an urgent unmet need for this patient population.

Non-linear effect of manufacturing on an environmental pollution index in Latin America.

Manufacturing is one of the primary sources of environmental pollution due to the emission of polluting gases and waste generation. This research aims to examine the manufacturing industry's effect on an environmental pollution index in nineteen Latin American countries using non-linear methods. The youth population, globalization, property rights, civil liberties, the unemployment gap, and government stability moderate the relationship between the two variables. The research has a temporal coverage between 1990 and 2017 and uses threshold regressions to verify the hypotheses. In order to obtain more specific inferences, we group countries according to the trade block and geographic region to which they belong. Our findings indicate that manufacturing has limited explanatory power for environmental pollution. This finding is supported by the fact that the manufacturing industry in the region is scarce. In addition, we find a threshold effect on the youth population, globalization, property rights, civil liberties, and government stability. Consequently, our results highlight the importance of institutional factors in designing and applying environmental mitigation mechanisms in developing regions.

Tumor Volume Nadir in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Treated With Alectinib.

PURPOSE: Patients with oncogene-driven advanced non-small-cell lung cancer (NSCLC) treated with effective targeted therapy demonstrate characteristic tumor volume dynamics with initial response, nadir, and subsequent regrowth. This study investigated tumor volume nadir and time to nadir in patients with ALK-rearranged advanced NSCLC treated with alectinib. MATERIALS AND METHODS: In patients with advanced ALK-rearranged NSCLC treated with alectinib monotherapy, tumor volume dynamics were evaluated on serial computed tomography (CT) scans using a previously validated CT tumor measurement technique. A linear regression model was built to predict tumor volume nadir. Time-to-event analyses were performed to evaluate time to nadir. RESULTS: Among 45 patients who experienced initial volume decrease, 37 patients (25 with tumor regrowth and 12 without regrowth but >6 months follow-up) were studied for nadir volume (Vp). The linear model to predict tumor volume nadir was built using the baseline tumor volume (V0): V0-Vp = .696 × V0 + 5,326 (P < 2 × 10-16; adjusted R2 = 0.86). The percent volume changes at nadir (median, -90.9%, mean, -85.3%) showed larger decrease in patients who were treated with alectinib as first-line therapy than in the ≥2nd-line group and were independent of V0 and clinical variables. Time to nadir had a median of 11.5 months and was longer in the first-line group (P = .04). CONCLUSION: The tumor nadir volume in patients with ALK-rearranged advanced NSCLC treated with alectinib can be predicted by the liner regression model and consists of approximately 30% of the baseline volume minus 5 cm3, providing additional insights into precision therapy monitoring and potential guides for local ablative therapy to prolong disease control.

Original Research: TikTok's 'Dancing Nurses' During the COVID-19 Pandemic: A Content Analysis.

BACKGROUND: Amid the challenges of the ongoing COVID-19 pandemic, health care workers are using social media to publish increasing numbers of posts, memes, and videos. On TikTok, a rapidly growing and widely used social networking platform, videos labeled "dancing nurses" have recently been trending. Whether nurses or the general public consider such videos to breach professional ethical standards is unknown. PURPOSE: The aim of this study was to analyze and describe the use of the social media platform TikTok by nurses whose videos featured dancing nurses during the ongoing pandemic. METHODS: Between March 1 and December 31, 2020, we conducted a search on TikTok using terms such as dancing nurse and hashtags such as "#dancingnurse." For each identified video, the numbers of followers, views, likes, concurrent COVID-19 morbidity and mortality rates, and other data were collected. For videos meeting the inclusion criteria, content analysis was performed to evaluate dancing nurse behaviors and apply the American Nurses Association (ANA) Code of Ethics for Nurses with Interpretive Statements, ANA social networking principles, and National Council of State Boards of Nursing social media guidelines. RESULTS: A total of 52 videos met all inclusion criteria and were included for analysis. These videos had a mean of 1.51 million views each. Among these videos, there were 356 violations of Code of Ethics provisions, social networking principles, and social media guidelines. Forty of the videos (77%) included a choreographed dance; 24 (46%) contained twerking and three (6%) featured dance moves such as pelvic thrusts and gyrations. CONCLUSION: The findings offer insight into how nurses are using TikTok, specifically with regard to posting videos that feature dancing nurses. Some of the analyzed videos included content that could be construed, in our view, as inappropriate and even sexually suggestive. The concern is that such videos could damage the professional image of nurses and downplay the seriousness of the current pandemic. It's essential that nurses who use social media consider the content and presentation of what they post. There is an urgent need for nurses to understand professional and workplace guidelines and policies regarding the use of social media, and how these may apply to content developed and posted on platforms such as TikTok.

The Vocalist in the Crib: the Flexibility of Respiratory Behaviour During Crying in Healthy Neonates.

OBJECTIVE: To evaluate the flexibility of respiratory behavior during spontaneous crying using an objective analysis of temporal measures in healthy neonates. PARTICIPANTS: A total of 1,375 time intervals, comprising breath cycles related to the spontaneous crying of 72 healthy, full-term neonates (35 females) aged between two and four days, were analyzed quantitatively. METHODS: Digital recordings (44 kHz, 16 bit) of cries emitted in a spontaneous, pain-free context were obtained at the University Children's Hospital Wurzburg. The amplitude-by-time representation of PRAAT: doing phonetics by computer (38) was used for the manual segmentation of single breath-cycles involving phonation. Cursors were set in these time intervals to mark the duration of inspiratory (IPh) and expiratory phases (EPh), and double-checks were carried out using auditory analyses. A PRAAT script was used to extract temporal features automatically. The only intervals analyzed were those that contained an expiratory cry utterance embedded within preceding and subsequent inspiratory phonation (IP). Beyond the reliable identification of IPh and EPh, this approach also guaranteed inter-individual and inter-utterance homogenization with respect to inspiratory strength and an unconstructed vocal tract. RESULTS: Despite the physiological constraints of the neonatal respiratory system, a high degree of flexibility in the ratio of IPh/EPh was observed. This ratio changed hyperbolically (r = 0.71) with breath-cycle duration. Descriptive statistics for all the temporal measures are reported as reference values for future studies. CONCLUSION: The existence of respiratory exploration during the spontaneous crying of healthy neonates is supported by quantitative data. From a clinical perspective, the data demonstrate the presence of a high degree of flexibility in the respiratory behavior, particularly neonates' control capability with respect to variable cry durations. These data are discussed in relation to future clinical applications.

Determinants of renewable and non-renewable energy consumption in hydroelectric countries.

In the past decades, renewable energy consumption has grown considerably because of environmental degradation caused by non-renewable energy consumption. This research aims to find the causal link between renewable and non-renewable energy consumption, human capital, and non-renewable energy price for the 53 most renewable energy-consuming countries worldwide (hydroelectric) during the period 1990-2017. We use data collected from the World Bank ( http://data.worldbank.org/data-catalog/world-development-indicators , 2018) and Statistical Review of World Energy ( https://www.bp.com/ , 2018). We test simultaneously two types of regressions in order to measure the degree of elasticity of the two types of energy by using econometric techniques for panel data. The results of the GLS models indicate that human capital has a stronger significant effect on renewable energy consumption at the global level, in the middle high-income countries and low-middle income countries, compared with non-renewable energy consumption. Besides, at the global level, there is a positive and statistically significant relationship between the non-renewable energy price and the two types of energy consumption. There is a long-run consumption of both types of energy. On the other hand, the one-way relationship between human capital and non-renewable energy price and renewable energy consumption is stronger than the relationship with non-renewable energy consumption. The policy implications derived from this study should be designed to promote human capital development in order to promote renewable energy consumption and increase the investment in renewable energy sources to guarantee their access to lower prices that reduce non-renewable energy consumption.

Obesity Exacerbates the Cytokine Storm Elicited by Francisella tularensis Infection of Females and Is Associated with Increased Mortality.

Infection with Francisella tularensis, the causative agent of the human disease tularemia, results in the overproduction of inflammatory cytokines, termed the cytokine storm. Excess metabolic byproducts of obesity accumulate in obese individuals and activate the same inflammatory signaling pathways as F. tularensis infection. In addition, elevated levels of leptin in obese individuals also increase inflammation. Since leptin is produced by adipocytes, we hypothesized that increased fat of obese females may make them more susceptible to F. tularensis infection compared with lean individuals. Lean and obese female mice were infected with F. tularensis and the immunopathology and susceptibility monitored. Plasma and tissue cytokines were analyzed by multiplex ELISA and real-time RT-PCR, respectively. Obese mice were more sensitive to infection, developing a more intense cytokine storm, which was associated with increased death of obese mice compared with lean mice. This enhanced inflammatory response correlated with in vitro bacteria-infected macrophage cultures where addition of leptin led to increased production of inflammatory cytokines. We conclude that increased basal leptin expression in obese individuals causes a persistent low-level inflammatory response making them more susceptible to F. tularensis infection and heightening the generation of the immunopathological cytokine storm.

Down-regulation of love feelings after a romantic break-up: Self-report and electrophysiological data.

Because remaining love feelings for an ex-partner are negatively associated with recovery from a romantic break-up, it may be helpful to decrease those love feelings. Love regulation is the use of behavioral or cognitive strategies to change the intensity of current feelings of romantic love. This study evaluated three regulation strategies: (1) negative reappraisal of the ex-partner, (2) reappraisal of love feelings, and (3) distraction. It was tested how these regulation strategies change love feelings for the ex-partner, valence of affect, and motivated attention for the ex-partner. Participants who were upset about a romantic break-up performed these regulation strategies before passively viewing a picture of their ex-partner, during which their electroencephalogram was recorded. Negative reappraisal decreased love feelings and made participants feel more unpleasant. Love reappraisal did not change how in love or pleasant/unpleasant participants felt. Distraction did not change love feelings but made participants feel more pleasant. This suggests that in the context of a romantic break-up, negative reappraisal is an effective love down-regulation strategy, whereas distraction is an effective positive emotion up-regulation strategy. Furthermore, all three strategies decreased motivated attention for the ex-partner, as indicated by a reduced amplitude of the late positive potential. This reduced motivated attention for the ex-partner could make it easier to deal with encounters of (reminders of) the ex-partner. Love regulation is a promising phenomenon with important everyday life and clinical implications. (PsycINFO Database Record

If you could see what we see, would it bother you?

OBJECTIVE: The purpose of our study was to determine whether the anatomic threshold for pelvic organ prolapse (POP) diagnosis and surgical success remains valid when the patient sees what we see on exam. METHODS: Two hundred participants were assigned, by computer-generated block randomization, to see one of four videos. Each video contained the same six clips representative of various degrees of anterior vaginal wall support. Participants were asked questions immediately after each clip. They were asked: "In your opinion, does this patient have a bulge or something falling out that she can see or feel in the vaginal area?" Similarly, they were asked to give their opinion on surgical outcome on a 4-point Likert scale. RESULTS: The proportion of participants who identified the presence of a vaginal bulge increased substantially at the level of early stage 2 prolapse (1 cm above the hymen), with 67 % answering yes to the question regarding bulge. The proportion of participants who felt that surgical outcome was less desirable also increased substantially at early stage 2 prolapse (1 cm above the hymen), with 52 % describing that outcome as "not at all" or "somewhat" successful. CONCLUSION: Early stage 2 POP (1 cm above the hymen) is the anatomic threshold at which women identify both a vaginal bulge and a less desirable surgical outcome when they see what we see on examination.

Suprapubic versus transurethral bladder drainage following reconstructive pelvic surgery: a comparison of patient satisfaction and quality of life.

INTRODUCTION AND HYPOTHESIS: To assess the differences in patient-reported, catheter-specific satisfaction and quality of life with either suprapubic or transurethral postoperative bladder drainage following reconstructive pelvic surgery. METHODS: This was a prospective study of all eligible women who were scheduled to undergo reconstructive surgery requiring bladder drainage during the study period November 2013 to March 2015. Women who did not undergo the planned procedure(s) or did not require bladder drainage were excluded. The primary outcome was patient-reported quality of life using catheter-specific instruments including the Catheter-related Quality of Life (CIQOL) instrument, and a modified version of the Intermittent Self-Catheterization Questionnaire (ISC-Q), designed to evaluate aspects of catheter-related quality of life and satisfaction specific to the needs of the individual. RESULTS: A total of 178 women were analyzed, 108 in the transurethral catheter group and 70 in the suprapubic group. Women with suprapubic bladder drainage had higher quality of life and satisfaction scores than women with transurethral bladder drainage as measured by the ISC-Q (68.31 ± 16.87 vs. 54.04 ± 16.95, mean difference 14.27, 95 % CI 9.15 - 19.39). There was no difference in quality of life by the CIQOL. After regression analysis, women with suprapubic bladder drainage were more satisfied with their catheter-specific needs despite longer duration of catheter use, more concurrent continence surgery, and higher trait anxiety. CONCLUSIONS: Differences in catheter-specific quality of life and patient satisfaction scores favoring suprapubic bladder drainage support its continued use in appropriately selected women for treatment of temporary postoperative urinary retention after reconstructive pelvic surgery.

Operationalizing the Measurement of Socioeconomic Position in Our Urogynecology Study Populations: An Illustrative Review.

OBJECTIVES: The purpose of this illustrative review is to provide guidance for the measurement of socioeconomic position when conducting health disparities research in urogynecology study populations. METHODS: Deidentified data were extracted from existing investigational review board-approved research databases for illustrative purposes. Attributes collected included the study participant's marital status, level of educational attainment (in number of years of school completed) and occupation as well as the study participant's last/only spouses' level of education and occupation. Average household and female socioeconomic position scores were calculated using two established composite indices: (1) Hollingshead Four Factor Index of Social Position, (2) Green's Socioeconomic Status scores, and 2 single-item indices: (1) Hauser-Warren Socioeconomic Index of Occupation, (2) level of educational attainment. RESULTS: The Hollingshead Four Factor Index of Social Position more than the Hauser-Warren Socioeconomic Index of Occupation provides researchers with a continuous score that is normally distributed with the least skew from the dataset. Their greater standard deviations and low kurtotic values increase the probability that statistically significant differences in health outcomes predicted by socioeconomic position will be detected compared with Green's socioeconomic status scores. CONCLUSIONS: Collection of socioeconomic data is an important first step in gaining a better understanding of health disparities through elimination of confounding bias, and for the development of behavioral, educational, and legislative strategies to eliminate them. We favor average household socioeconomic position scores over female socioeconomic position scores because average household socioeconomic position scores are more reflective of overall resources and opportunities available to each family member.

Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence.

OBJECTIVES: We previously showed that management with a novel vaginal bowel control system was efficacious in women with moderate to severe fecal incontinence. The objective of this secondary analysis was to evaluate the clinical characteristics associated with device-fitting success. METHODS: This is a secondary analysis of an institutional review board-approved, multicenter, prospective, open-label clinical study of women aged 19 to 75 years with 4 or more episodes of fecal incontinence recorded on a 2-week baseline bowel diary. Those successfully fitted with the vaginal bowel control device entered a 1-month treatment period, and efficacy was assessed with a repeat bowel diary. Demographic data, medical and surgical history, and pelvic examination findings were compared across women with successful and unsuccessful completion of the fitting period. Multivariate logistic regression analysis was performed. RESULTS: Six clinical sites in the United States recruited from August 2012 through October 2013. Overall, 110 women underwent attempted fitting, of which 61 (55.5%) of 110 were successful and entered the treatment portion of the study. Multivariate logistic regression analysis revealed that previous prolapse surgery (P = 0.007) and shorter vaginal length (P = 0.041) were independently associated with unsuccessful fitting. Women who have not undergone previous prolapse surgery had 4.7 times the odds (95% confidence interval [CI], 1.53-14.53) of a successful fit. In addition, for every additional centimeter of vaginal length, women had 1.49 times the odds (95% CI, 1.02-2.17) of a successful fit. CONCLUSIONS: Shorter vaginal length and previous prolapse surgery were associated with an increased risk of fitting failure. These findings may be used to inform patients regarding their expectation of successful fitting.

Impact of a Novel Vaginal Bowel Control System on Bowel Function.

BACKGROUND: Bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to fecal incontinence. OBJECTIVE: The purpose of this study was to examine the impact of a vaginal bowel control system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation. DESIGN: This was a secondary analysis of a multicenter, prospective clinical trial. SETTINGS: This study was conducted at 6 sites in the United States, including university hospitals and private practices in urogynecology and colorectal surgery. PATIENTS: A total of 56 evaluable female subjects aged 19 to 75 years with 4 or more fecal incontinence episodes on a 2-week bowel diary were included. INTERVENTIONS: The study intervention was composed of the vaginal bowel control system, consisting of a vaginal insert and pressure-regulated pump. MAIN OUTCOME MEASURES: Subjects completed a 2-week baseline diary of bowel function before and after treatment completed at 1 month. Fecal urgency, consistency of stool (Bristol score), and completeness of evacuation were recorded for all bowel movements. RESULTS: Use of the insert was associated with an improvement in bowel function across all 4 categories. Two thirds (8/12) of subjects with a high frequency of daily stools (more than 2 per day) shifted to a normal or low frequency of stools. Analysis of Bristol stool scale scores demonstrated a significant reduction in the proportion of all bowel movements reported as liquid (Bristol 6 or 7), from 36% to 21% (p = 0.0001). On average, 54% of stools were associated with urgency at baseline compared with 26% at 1 month (p < 0.0001). Incomplete evacuations with all bowel movements were reduced from 39% to 26% of subjects at 1 month (p = 0.0034). LIMITATIONS: The study follow-up period was 1 month (with an optional additional 2 months). CONCLUSIONS: The vaginal bowel control system was associated with an improvement in bowel symptoms and function, including reduced bowel movement frequency, less fecal urgency, increased solid consistency, and improved evacuation in patients with significant fecal incontinence.

Clinical Risk Factors Do Not Predict Shoulder Dystocia.

Objective: To compare 2 different risk factor models for the prediction of shoulder dystocia. Study Design: We performed a retrospective study of women with vaginal deliveries at a single institution over an 8-year period. Two distinct multivariable logistic regression models were used to evaluate the occurrence of shoulder dystocia: a traditional model used information based on birthweight and macrosomia, and a clinical model used information based on esti-mated fetal weight and suspected macrosomia. Results: Of the 13,998 deliveries analyzed, there were 221 cases of shoulder dystocia (1.6%). In addition to the macrosomia or suspected macrosomia variables, the final models included prolonged second stage of labor, diabetes status, and oxytocin use. Neither model was highly sensitive or highly specific, and neither demonstrated a cutoff threshold that yielded a clinically viable PPV. Conclusion: Despite the presence of 1 or more risk factors for shoulder dystocia, its occurrence remains largely an unpredictable clinical event.

Obliterative Surgery for the Treatment of Pelvic Organ Prolapse: A Patient Survey on Reasons for Surgery Selection and Postoperative Decision Regret and Satisfaction.

OBJECTIVES: To identify patient-reported reasons for selecting obliterative surgery for the purpose of predicting decision regret and satisfaction. METHODS: We created a deidentified database of patients who underwent an obliterative procedure for prolapse from 2006 to 2013. Patients were excluded if they declined study participation, were deceased, or had dementia. Participants completed a survey regarding reasons for selecting obliterative surgery and a modified version of validated questionnaires on decision regret (Decision Regret Scale-Pelvic Floor Disorder) and satisfaction (Satisfaction with Decision Scale-Pelvic Floor Disorder). Parsimonious multivariate linear regression models were constructed to determine if any of the reasons given for choosing obliterative surgery were independent predictors of decision regret and satisfaction after controlling for significant sociodemographic, clinical, and surgical outcome data identified by bivariate analysis. RESULTS: Seventy-seven women completed the surveys. "To follow my doctor's recommendations" and "no longer sexually active," and/or "did not plan to be" as reasons for selecting obliterative surgery made the most difference; however, these reasons were not identified as independent predictors of decision regret or satisfaction after controlling for confounders. The regret linear regression models identified preoperative sexual activity rather than the patient-reported reason "no longer sexually active and/or did not plan to be," as the only independent predictor of more decision regret after obliterative surgery (B coefficient 1.68, P < 0.01). The satisfaction linear regression models identified reoperation for any reason as an independent predictor of lower satisfaction (ß, -0.24; P = 0.04) and the patient-reported reason for choosing obliterative surgery "not interested in pessary" as a predictor of higher satisfaction (ß, 0.30, P = 0.01). CONCLUSIONS: This study advances our knowledge about the obliterative surgical decision making process. Behavioral and educational interventions directed at improving patient and physician communications concerning the dynamics of sexual health issues in an aging population will likely decrease regret when obliterative surgery is chosen. Minimizing reoperation after obliterative surgery through increased experience, knowledge, and improved surgical skills and patient validation when pessary is declined will likely improve satisfaction when obliterative surgery is chosen.

A vaginal bowel-control system for the treatment of fecal incontinence.

OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms "very much better" or "much better." There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P≤.007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73-95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01655498. LEVEL OF EVIDENCE: : II.

Aging diminishes lamellar and woven bone formation induced by tibial compression in adult C57BL/6.

Aging purportedly diminishes the ability of the skeleton to respond to mechanical loading, but recent data show that old age did not impair loading-induced accrual of bone in BALB/c mice. Here, we hypothesized that aging limits the response of the tibia to axial compression over a range of adult ages in the commonly used C57BL/6. We subjected the right tibia of old (22 month), middle-aged (12 month) and young-adult (5 month) female C57BL/6 mice to peak periosteal strains (measured near the mid-diaphysis) of -2200 µÎµ and -3000 µÎµ (n=12-15/age/strain) via axial tibial compression (4 Hz, 1200 cycles/day, 5 days/week, 2 weeks). The left tibia served as a non-loaded, contralateral control. In mice of every age, tibial compression that engendered a peak strain of -2200 µÎµ did not alter cortical bone volume but loading to a peak strain of -3000 µÎµ increased cortical bone volume due in part to woven bone formation. Both loading magnitudes increased total volume, medullary volume and periosteal bone formation parameters (MS/BS, BFR/BS) near the cortical midshaft. Compared to the increase in total volume and bone formation parameters of 5-month mice, increases were less in 12- and 22-month mice by 45-63%. Moreover, woven bone incidence was greatest in 5-month mice. Similarly, tibial loading at -3000 µÎµ increased trabecular BV/TV of 5-month mice by 18% (from 0.085 mm3/mm3), but trabecular BV/TV did not change in 12- or 22-month mice, perhaps due to low initial BV/TV (0.032 and 0.038 mm3/mm3, respectively). In conclusion, these data show that while young-adult C57BL/6 mice had greater periosteal bone formation following loading than middle-aged or old mice, aging did not eliminate the ability of the tibia to accrue cortical bone.