Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results.

OBJECTIVE: The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months. STUDY DESIGN: A total of 225 women were randomized to receive MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate. RESULTS: There was no statistically significant difference in the subjective (92.2% vs 94.2%; P = .78; difference, 2.0%; 95% confidence interval, -2.7% to +6.7%) or objective (94.4% vs 96.7%; P = .50; difference, 2.3%; 95% confidence interval, -1.5% to +6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms. CONCLUSION: MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months' follow-up in women without intrinsic sphincter deficiency.

Magnitude of income-related disparities in adverse perinatal outcomes.

BACKGROUND: To assess and compare multiple measurements of socioeconomic position (SEP) in order to determine the relationship with adverse perinatal outcomes across various contexts. METHODS: A birth registry, the Nova Scotia Atlee Perinatal Database, was confidentially linked to income tax and related information for the year in which delivery occurred. Multiple logistic regression was used to examine odds ratios between multiple indicators of SEP and multiple adverse perinatal outcomes in 117734 singleton births between 1988 and 2003. Models for after tax family income were also adjusted for neighborhood deprivation to gauge the relative magnitude of effects related to SEP at both levels. Effects of SEP were stratified by single- versus multiple-parent family composition, and by urban versus rural location of residence. RESULTS: The risk of small for gestational age and spontaneous preterm birth was higher across all the indicators of lower SEP, while risk for large for gestational age was lower across indicators of lower SEP. Higher risk of postneonatal death was demonstrated for several measures of lower SEP. Higher material deprivation in the neighborhood of residence was associated with increased risk for perinatal death, small for gestational age birth, and iatrogenic and spontaneous preterm birth. Family composition and urbanicity were shown to modify the association between income and some perinatal outcomes. CONCLUSIONS: This study highlights the importance of understanding the definitions of SEP and the mechanisms that lead to the association between income and poor perinatal outcomes, and broadening the types of SEP measures used in some cases.

Which women develop urgency or urgency urinary incontinence following midurethral slings?

INTRODUCTION AND HYPOTHESIS: De novo urgency has a negative impact on women after midurethral sling (MUS). We aimed to identify risk factors for de novo urgency (dU) and urgency urinary incontinence (dUUI) following MUS, using multivariate analysis. METHODS: We investigated 358 consecutive women with only stress urinary incontinence (SUI) [or urodynamic stress incontinence (USI)] and 598 women with both SUI (or USI) and urgency (but not UUI) who underwent MUS with a mean follow-up of 50 months. Women who developed dU or dUUI at long-term follow-up were compared to those who did not. RESULTS: dU occurred in 27.7 % (99/358) and dUUI occurred in 13.7 % (82/598) of women at long-term follow-up after midurethral sling. Intrinsic sphincter deficiency {odds ratio (OR) dU 3.94 [95 % confidence interval (CI) 1.50-10.38]; OR dUUI 2.5 (1.31-4.80)}, previous stress incontinence surgery [sling: OR dU 3.69 (1.45-9.37); colposuspension: OR dUUI 2.5 (1.23-5.07)], previous prolapse surgery [OR dU 2.45 (1.18-5.10)], preexisting detrusor overactivity [OR dU 1.99 (1.15-3.48); OR dUUI 1.85 (1.31-2.60)] increased the risk, whereas performing concomitant apical prolapse surgery [OR dU 0.5 (0.41-0.81); OR dUUI 0.29 (0.087-0.97)] significantly decreased the risk. Women are more likely to not recommend surgery when they experienced dU (18.2 vs 0.8 %, p < 0.0001) or dUUI (20.7 vs 2.1 %, p < 0.0001). CONCLUSIONS: Urodynamic parameters, history of prior incontinence or prolapse surgery and concomitant apical prolapse operation were important predictors of dU or dUUI following MUS.

Determinants of place of death: a population-based retrospective cohort study.

BACKGROUND: As Canada's population ages, the location of end of life care (whether at home, extended care facility or hospital) may change depending on the location of death. We carried out a study to identify determinants of the place of death. METHODS: Data on deaths in British Columbia between 2004 and 2008 were obtained from the Vital Statistics Agency. Place of death was categorized into home, extended care facility, hospital or other. Logistic regression analyses were used to estimate the effects of age, sex, marital status, residence, place of birth and cause of death on place of death using adjusted odds ratios and 95% confidence intervals (95% CI). RESULTS: Of the 153,111 deaths in the study, 16.5% occurred at home, 29.0% in extended care, 51.0% in hospital and 3.5% occurred elsewhere. Male deaths were less likely to occur in extended care as compared with female deaths (odds ratio 0.73, 95% CI 0.71-0.75). Age (odds ratio 3.31, 95% CI 3.19-3.45 for those for ≥90 vs 70-79 years), marital status (odds ratio 1.42, 95% CI 1.38-1.47 widowed vs married), residence (odds ratio 0.80, 95% CI 0.76-0.83 rural vs Vancouver), place of birth (odds ratio 0.80, 95% CI 0.75-0.86 China vs Canada) and cause of death (odds ratio 3.91, 95% CI 3.69-4.13 dementia vs cancer) were also associated with death in extended care. CONCLUSIONS: Information on determinants of place of death can inform public health policy regarding care at the end of life and make resource allocation more efficient.

Temporal trends in the frequency of twins and higher-order multiple births in Canada and the United States.

BACKGROUND: The dramatic increase in multiple births is an important public health issue, since such births have elevated risks for adverse perinatal outcomes. Our objective was to explore the most recent temporal trends in rates of multiple births in Canada and the United States. METHODS: Live birth data from Canada (excluding Ontario) and the United States from 1991-2009 were used to calculate rates of twins, and triplet and higher-order multiples (triplet+). Temporal trends were assessed using tests for linear trend and absolute and relative changes in rates. RESULTS: Twin live births in the United States increased from 23.1 in 1991 to 32.2 per 1,000 live births in 2004, remained stable between 2004 and 2007, and then increased slightly to an all-time high of 33.2 per 1,000 live births in 2009. In Canada, rates also increased from 20.0 in 1991 to 28.3 per 1,000 live births in 2004, continued to increase modestly between 2004 and 2007, and rose to a high of 31.4 per 1,000 in 2009. Rates of triplet+ live births in the United States increased dramatically from 81.4 in 1991 to 193.5 per 100,000 live births in 1998, remained stable between 1998 and 2003 and then decreased to 148.9 per 100,000 in 2007. The rate declined marginally in 2008, but then rose again in 2009 to 153.5 per 100,000. Rates of triplet+ live births were much lower in Canada, although the temporal pattern of change was similar. CONCLUSION: The rate of twin live births in the United States and Canada continues to increase, though more modestly than during the 1990s. Recent declines in rates of triplet+ live births in both countries have been followed by unstable trends.

Mesh-related chronic infections in silicone-coated polyester suburethral slings.

INTRODUCTION AND HYPOTHESIS: despite claims of equivalence to the tension-free vaginal tape, a variety of suburethral slings have been introduced, with various modifications. Complications in certain synthetic slings and meshes have led to a recent FDA public health notification. METHODS: we report the case histories and management of five women with complications following implant of an InFast sling. RESULTS: four of the five patients presented with symptom of chronic vaginal discharge, one presenting with irritative voiding symptoms and bladder pain. Resolution of presenting symptoms requires total removal of this silicone-coated polyester mesh, which often requires a combined vaginal-abdominal approach. CONCLUSIONS: the silicone-coated mesh of the AMS InFAST sling, can become a focus for chronic infection forming a sinus tract into the vagina or other viscus, causing symptoms years after its placement.

Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial).

BACKGROUND: Co-bedding, a developmental care strategy, is the practice of caring for diaper clad twins in one incubator (versus separating and caring for each infant in separate incubators), thus creating the opportunity for skin-to-skin contact and touch between the twins. In studies of mothers and their infants, maternal skin-to-skin contact has been shown to decrease procedural pain response according to both behavioral and physiological indicators in very preterm neonates. It is uncertain if this comfort is derived solely from maternal presence or from stabilization of regulatory processes from direct skin contact. The intent of this study is to compare the comfort effect of co-bedding (between twin infants who are co-bedding and those who are not) on infant pain response and physiologic stability during a tissue breaking procedure (heelstick). METHODS/DESIGN: Medically stable preterm twin infants admitted to the Neonatal Intensive Care Unit will be randomly assigned to a co-bedding group or a standard care group. Pain response will be measured by physiological and videotaped facial reaction using the Premature Infant Pain Profile scale (PIPP). Recovery from the tissue breaking procedure will be determined by the length of time for heart rate and oxygen saturation to return to baseline. Sixty four sets of twins (n = 128) will be recruited into the study. Analysis and inference will be based on the intention-to-treat principle. DISCUSSION: If twin contact while co-bedding is determined to have a comforting effect for painful procedures, then changes in current neonatal care practices to include co-bedding may be an inexpensive, non invasive method to help maintain physiologic stability and decrease the long term psychological impact of procedural pain in this high risk population. Knowledge obtained from this study will also add to existing theoretical models with respect to the exact mechanism of comfort through touch. TRIAL REGISTRATION: NCT00917631.

TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial.

INTRODUCTION: Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up. OBJECTIVE: To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence. METHODS: Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were analysed statistically. RESULTS: Between February 2011 and January 2016,a total of 246 women were randomized to receive MiniArc (121) or TVT Abbrevo (125). Baseline characteristics were clinically balanced in both groups. At 6 months subjective (94.4% vs 95.7% p=0.74) and Objective (92.9% vs 95.9% p=0.49) cure rates were high and not statistically different. At 12 months there were also no differences in subjective (73.6% vs 76.9% p=0.73) or objective (90.5% vs 96.0% p=0.21) cure rates. No differences were found in functional outcomes or when adjusted for potential confounding factors such as age, parity, BMI or menopausal status. CONCLUSION: We found no significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo.

The effect of hypertensive disorders in pregnancy on small for gestational age and stillbirth: a population based study.

BACKGROUND: Hypertensive disorders in pregnancy are leading causes of maternal, fetal and neonatal morbidity and mortality worldwide. However, studies attempting to quantify the effect of hypertension on adverse perinatal outcomes have been mostly conducted in tertiary centres. This population-based study explored the frequency of hypertensive disorders in pregnancy and the associated increase in small for gestational age (SGA) and stillbirth. METHODS: We used information on all pregnant women and births, in the Canadian province of Nova Scotia, between 1988 and 2000. Pregnancies were excluded if delivery occurred < 20 weeks, if birthweight was < 500 grams, if there was a high-order multiple pregnancy (greater than twin gestation), or a major fetal anomaly. RESULTS: The study population included 135,466 pregnancies. Of these, 7.7% had mild pregnancy-induced hypertension (PIH), 1.3% had severe PIH, 0.2% had HELLP (hemolysis, elevated liver enzymes, low platelets), 0.02% had eclampsia, 0.6% had chronic hypertension, and 0.4% had chronic hypertension with superimposed PIH. Women with any hypertension in pregnancy were 1.6 (95% CI 1.5-1.6) times more likely to have a live birth with SGA and 1.4 (95% CI 1.1-1.8) times more likely to have a stillbirth as compared with normotensive women. Adjusted analyses showed that women with gestational hypertension without proteinuria (mild PIH) and with proteinuria (severe PIH, HELLP, or eclampsia) were more likely to have infants with SGA (RR 1.5, 95% CI 1.4-1.6 and RR 3.2, 95% CI 2.8-3.6, respectively). Women with pre-existing hypertension were also more likely to give birth to an infant with SGA (RR 2.5, 95% CI 2.2-3.0) or to have a stillbirth (RR 3.2, 95% CI 1.9-5.4). CONCLUSIONS: This large, population-based study confirms and quantifies the magnitude of the excess risk of small for gestational age and stillbirth among births to women with hypertensive disease in pregnancy.

A parsimonious explanation for intersecting perinatal mortality curves: understanding the effect of plurality and of parity.

BACKGROUND: Birth weight- and gestational age-specific perinatal mortality curves intersect when compared across categories of maternal smoking, plurality, race and other factors. No simple explanation exists for this paradoxical observation. METHODS: We used data on all live births, stillbirths and infant deaths in Canada (1991-1997) to compare perinatal mortality rates among singleton and twin births, and among singleton births to nulliparous and parous women. Birth weight- and gestational age-specific perinatal mortality rates were first calculated by dividing the number of perinatal deaths at any given birth weight or gestational age by the number of total births at that birth weight or gestational age (conventional calculation). Gestational age-specific perinatal mortality rates were also calculated using the number of fetuses at risk of perinatal death at any given gestational age. RESULTS: Conventional perinatal mortality rates among twin births were lower than those among singletons at lower birth weights and earlier gestation ages, while the reverse was true at higher birth weights and later gestational ages. When perinatal mortality rates were based on fetuses at risk, however, twin births had consistently higher mortality rates than singletons at all gestational ages. A similar pattern emerged in contrasts of gestational age-specific perinatal mortality among singleton births to nulliparous and parous women. Increases in gestational age-specific rates of growth-restriction with advancing gestational age presaged rising rates of gestational age-specific perinatal mortality in both contrasts. CONCLUSIONS: The proper conceptualization of perinatal risk eliminates the mortality crossover paradox and provides new insights into perinatal health issues.

Ruptured tubal ectopic pregnancy with negative serum beta hCG--a case for ongoing vigilance?

A 25-year-old female with a history of recent miscarriage presents with haemodynamic shock and a negative serum beta hCG. She presents to six different healthcare facilities within a single metropolitan area, during which a pelvic ultrasound scan showed an empty uterus with a subnormal rise in serum beta hCG. Suspected ruptured tubal ectopic pregnancy was confirmed following laparoscopy and salpingectomy, with histopathological confirmation of chorionic villi in the extirpated fallopian tube. This case report highlights the ongoing clinical diagnostic challenges that are associated with ectopic pregnancy; illustrates the importance of teamwork; and perhaps also draws attention to the need for a robust protocol to facilitate consistent, good-quality early pregnancy care for all women.

Trends in twin neonatal mortality rates in the United States, 1989 through 1999: influence of birth registration and obstetric intervention.

OBJECTIVE: We sought to evaluate the contributions of changes in birth registration, labor induction, and cesarean delivery on trends in twin neonatal mortality rates. STUDY DESIGN: We conducted a population-based, retrospective cohort study of twin live births, using linked birth-infant death data in the United States (1989-1999). Relative risks and 95% confidence intervals that quantified changes in neonatal (0-27 days) mortality rates were derived from ecologic logistic regression models that were fit after aggregation of the data by each state in the United States. RESULTS: The frequency of live born twins who weighed <500 g increased 72%, from 0.7% in 1989 to 1.2% in 1999, of live born twins who weighed 500 to 749 g and 750 to 999 g increased by 55% and 28%, respectively, between 1989 and 1999. Preterm birth rates increased by 19%, from 46.2% in 1989 to 57.2% in 1999. The rate of labor induction increased from 5.8% to 13.9%, and the cesarean delivery rate increased from 49.8% to 56.3%. Between 1989 to 1991 and 1997 to 1999, the crude neonatal mortality rates among twins who weighed >or=500 g declined by 37% (95% CI, 35%-40%) from 21.5 to 13.6 per 1000 twin live births. Adjustments for preterm labor induction, preterm cesarean delivery, term labor induction, term cesarean delivery, and sociodemographic factors had little influence on neonatal mortality rate trends. CONCLUSION: Increases in preterm birth because of obstetric intervention among twins have not led to increases in twin neonatal mortality rates in the United States.