Selphee Tang

Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial.

OBJECTIVE: To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. METHOD: Women with SUI were randomly allocated to either transobturator tape or TVT procedures and reviewed at 12 months after surgery. The primary outcome was objective evidence of “cure,” evaluated by standardized pad test (cure defined as less than 1 g urine leaked). Other outcomes included complications, subjective cure, incontinence-related quality of life, return to usual sexual activity, and satisfaction with surgery. Primary analysis compared the proportion of patients in each group who were cured at 12-month follow-up. RESULTS: A total of 199 women participated (94 in the transobturator tape group, 105 in the TVT group). Sixty-eight women (81%) in the transobturator tape group were cured, compared with 67 (77%) in the TVT group (relative risk 1.05, 95% confidence interval 0.90–1.23, P=.577). On vaginal examination, the tape was palpable for 68 women (80%) in the transobturator tape group and for 24 (27%) in the TVT group (relative risk 0.22, 95% confidence interval 0.13–0.37, P<.001). More women in the transobturator tape group experienced groin pain during vaginal palpation (13 [15%] in the transobturator tape group and five [6%] in the TVT group, P=.044). Quality of life improved significantly from baseline in both groups (30-point improvement in IIQ-7 score for both groups). CONCLUSION: At 12 months, the majority of women had minimal leakage and their quality of life had improved significantly, but differences were not observed between groups. The presence of palpable tape, particularly among the transobturator tape group, is concerning; longer follow-up is needed to determine whether this outcome leads to extrusion or resolves over time. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00234754. LEVEL OF EVIDENCE: I

Vaginal progesterone to prevent preterm birth in multiple pregnancy: a randomized controlled trial.

Abstract Aim: We sought to assess the effect of progesterone in increasing or decreasing duration of pregnancy for mothers with twins and triplets. Methods: Women with multiple pregnancy were randomized at 16+0 to 20+6 weeks’ gestation to receive daily doses of either 90 mg progesterone vaginal gel or placebo until 35+6 weeks or delivery. Primary outcome was gestational age (GA) at delivery. Secondary outcomes included preterm birth, infant morbidity and mortality, and adverse events up to 28 days after delivery. A sample size of 40 per group was required to detect a 2-week difference in GA at delivery. Results: Eighty-four women were randomized (42 to progesterone, 42 to placebo). Median GA at delivery was 36+3 and 36+2, respectively (difference, 1 day; 95% confidence interval, 4 to –1 days, P=0.585). There were no clinically or statistically significant differences between groups for risk of delivery before 35 or 37 weeks’ GA, rates of infant morbidity and mortality, treatment compliance, or adverse events. Conclusions: Daily treatment with progesterone gel did not prolong multiple pregnancy compared with placebo. Effective prevention strategies are needed to reduce preterm deliveries among women with multiple gestations.

Diagnostic accuracy of rapid phIGFBP-I assay for predicting preterm labor in symptomatic patients

Objective:To estimate sensitivity, specificity, positive and negative predictive values (PPV, NPV) of insulin-like growth factor binding protein-1 (phIGFBP-1) test in predicting preterm delivery in women with symptoms of preterm labor. Secondary objectives were to compare test characteristics of the phIGFBP-1 and fetal fibronectin (fFN) tests.Study Design:Labor and delivery units in two Calgary hospitals. Subjects were 349 women with suspected labor between 24 and 35 weeks gestational age (GA). Women had cervical phIGFBP-1 test +/− and fFN testing. Sensitivity, specificity, PPV and NPV were estimated. Primary outcome was birth <37 weeks GA.Result:Sensitivity of phIGFBP-1 test for delivery <37 weeks was 0.39; specificity, 0.76; PPV, 0.24; NPV, 0.86. NPV of phIGFBP-1 did not differ greatly from that of fFN testing (0.88).Conclusion:NPV did not differ between phIGFBP-1 and fFN for delivery <37 weeks. Neither test improves on pretest probability of delivery <37 weeks, so clinicians must decide whether the use of either test is justified.

Prospective risk of stillbirth and neonatal complications in twin pregnancies: systematic review and meta-analysis

Objective To determine the risks of stillbirth and neonatal complications by gestational age in uncomplicated monochorionic and dichorionic twin pregnancies. Design Systematic review and meta-analysis. Data sources Medline, Embase, and Cochrane databases (until December 2015). Review methods Databases were searched without language restrictions for studies of women with uncomplicated twin pregnancies that reported rates of stillbirth and neonatal outcomes at various gestational ages. Pregnancies with unclear chorionicity, monoamnionicity, and twin to twin transfusion syndrome were excluded. Meta-analyses of observational studies and cohorts nested within randomised studies were undertaken. Prospective risk of stillbirth was computed for each study at a given week of gestation and compared with the risk of neonatal death among deliveries in the same week. Gestational age specific differences in risk were estimated for stillbirths and neonatal deaths in monochorionic and dichorionic twin pregnancies after 34 weeks’ gestation. Results 32 studies (29u2009685 dichorionic, 5486 monochorionic pregnancies) were included. In dichorionic twin pregnancies beyond 34 weeks (15 studies, 17u2009830 pregnancies), the prospective weekly risk of stillbirths from expectant management and the risk of neonatal death from delivery were balanced at 37 weeks’ gestation (risk difference 1.2/1000, 95% confidence interval −1.3 to 3.6; I2=0%). Delay in delivery by a week (to 38 weeks) led to an additional 8.8 perinatal deaths per 1000 pregnancies (95% confidence interval 3.6 to 14.0/1000; I2=0%) compared with the previous week. In monochorionic pregnancies beyond 34 weeks (13 studies, 2149 pregnancies), there was a trend towards an increase in stillbirths compared with neonatal deaths after 36 weeks, with an additional 2.5 per 1000 perinatal deaths, which was not significant (−12.4 to 17.4/1000; I2=0%). The rates of neonatal morbidity showed a consistent reduction with increasing gestational age in monochorionic and dichorionic pregnancies, and admission to the neonatal intensive care unit was the commonest neonatal complication. The actual risk of stillbirth near term might be higher than reported estimates because of the policy of planned delivery in twin pregnancies. Conclusions To minimise perinatal deaths, in uncomplicated dichorionic twin pregnancies delivery should be considered at 37 weeks’ gestation; in monochorionic pregnancies delivery should be considered at 36 weeks. Systematic review registration PROSPERO CRD42014007538.

Need for Supplemental Oxygen at Discharge in Infants with Bronchopulmonary Dysplasia Is Not Associated with Worse Neurodevelopmental Outcomes at 3 Years Corrected Age

Objectives To determine if chronic oxygen dependency (discharge home on supplemental oxygen) in children with bronchopulmonary dysplasia (BPD; defined as requirement for supplemental O2 at 36 weeks postmenstrual age) predicts neurodevelopmental disability rates and growth outcomes at 36 months corrected age (CA). Study Design Longitudinal cohort study. Setting Southern Alberta regional center located at high altitude. Participants Preterm infants weighing ≤1250 grams with no BPD, BPD, and BPD with chronic oxygen dependency. Main outcome measures Neurodevelopmental and growth outcomes. Results Of 1563 preterm infants admitted from 1995–2007, 1212 survived. Complete follow-up data were available for 1030 (85%) children. Children in BPD and BPD with chronic oxygen dependency groups had significantly lower birth weights, gestational ages, prolonged mechanical ventilation and oxygen supplementation and received more postnatal steroids, compared to those without BPD. Children with BPD and BPD with chronic oxygen dependency were more likely to be below the 5th centile in weight and height compared to those without BPD but there was little difference between the BPD and BPD with chronic oxygen dependency groups. After controlling for confounding variables, children who had BPD and BPD with chronic oxygen dependency had higher odds of neurodevelopmental disability compared to those without BPD [OR (odds ratio) 1.9 (95%CI 1.1 to 3.5) and OR 1.8 (1.1 to 2.9), respectively], with no significant difference between BPD and BPD with chronic oxygen dependency [OR 0.9 (95% CI 0.6 to 1.5)]. Conclusions BPD and BPD with chronic oxygen dependency in children predicts abnormal neurodevelopmental outcomes at 36 months CA. However, the neurodevelopmental disability rates were not significantly higher in BPD with chronic oxygen dependency children compared to children with BPD only. Compared to those without BPD, growth is impaired in children with BPD and BPD with chronic oxygen dependency, but no difference between the latter two groups.

Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial.

OBJECTIVE: To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse (POP) surgery using a repair augmented with porcine small intestine submucosa mesh (Mesh Group) compared with those who had a native tissue repair (No Mesh Group). METHODS: This was a randomized controlled trial with 12 months follow-up. The surgical procedure was identical in both groups except for the placement of intervening mesh. The primary outcome was anatomical “cure” (Ba of −1 or less on Pelvic Organ Prolapse Quantification [POP-Q]). Secondary outcomes included POP-Q stage, patient-reported outcomes, and patient satisfaction. The study was powered to detect a 40% difference at 80% power (&agr;=0.05). RESULTS: Fifty-seven women were randomized (28 to Mesh Group, 29 to No Mesh Group). Forty-five (79%) underwent concomitant surgery. At the 12-month follow-up, 56% (15/27) in the Mesh Group and 61% (17/28) in the No Mesh Group were considered cured (relative risk 0.90, 95% confidence interval 0.52–1.54). There were no significant differences between groups in recurrent or persistent prolapse (7% in each group) nor in patient-reported outcomes at 12 months. Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group. CONCLUSION: No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair. In our study, porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT0095544. LEVEL OF EVEDIENCE: I

Goal achievement as a patient‐generated outcome measure for stress urinary incontinence

Objectivesu2002 To explore women’s goals and goal attainment for the conservative and surgical treatment of stress urinary incontinence (SUI), and to examine the feasibility of Goal Attainment Scaling (GAS) as an outcome measure in this population.

Vaginal paravaginal repair with porcine small intestine submucosa: midterm outcomes.

Objective: This study aimed to determine the midterm efficacy of porcine small intestine submucosa for paravaginal repairs of anterior vaginal prolapse. Methods: One hundred five women underwent repairs between 2003 and 2006 and met our inclusion criteria. Women were invited to return for a pelvic examination and to fill out validated questionnaires. Objective failure was defined as anterior prolapse recurrence at or beyond the hymen. Results: Fifty-nine women (56%) were available for follow-up. Median age of patients was 60 years (range, 26-80 years) and 83% had a parity of 2 or more. Ninety-seven percent of patients had a preoperative prolapse stage of 2 or more. Follow-up ranged from 1 to 5 years (median, 27.5 months; interquartile range, 14.5). The most common postoperative complication was transient voiding dysfunction (23.7%). Objective cure rate was 68.8%. A positive change in bladder, vaginal, and bowel symptoms (a little better, much better, or very much better) was reported by 69.5%, 59.3%, and 25.5% of women, respectively. Thirty-one women (52.5%) were sexually active at postoperative follow-up. Only 4 women (6.8%) were not sexually active because of pelvic symptoms. Dyspareunia was reported by 8.3% of the 48 women who returned for a clinic follow-up. Twenty-four women (40.7%) were not sexually active postoperatively, for reasons unrelated to their surgeries. Conclusions: Vaginal paravaginal repair using porcine xenograft is a safe procedure whose long-term efficacy needs further evaluation through prospective trials.

Does chronic oxygen dependency in preterm infants with bronchopulmonary dysplasia at NICU discharge predict respiratory outcomes at 3 years of age

Objective:To determine whether chronic oxygen dependency at the time of discharge from the neonatal intensive care unit (NICU) in infants with bronchopulmonary dysplasia (BPD) predicts respiratory outcomes at 3 years.Study design:Preterm infants ⩽1250u2009g without BPD, BPD and BPD with chronic oxygen dependency were identified from the Southern Alberta Perinatal Follow-up clinic database (1995–2007). Respiratory outcomes at 4, 8, 18 and 36 months corrected age following NICU discharge were examined. Univariate analyses were done.Results:Out of 1563 infants admitted to the NICU, 1212 survived. Complete follow-up data at 36 months were available for 1030 (85%) children. Children with BPD with or without chronic oxygen dependency had significantly (P<0.001) lower birth weights and gestational ages, and greater post-natal steroid use, compared with those with no BPD. At 4, 8 and 18 months follow-up, the use of respiratory medications and supplemental oxygen were both significantly higher in the BPD infants with chronic oxygen dependency group compared with the no-BPD group and BPD group. At 36 months, children in the BPD with chronic oxygen dependency group were more likely to use respiratory medications and supplemental oxygen vs the no-BPD or the BPD groups. At 4, 8 and 36 months of age, more children in the BPD with chronic oxygen dependency group had post-neonatal chronic lung disease (PNCLD) than children in the other groups, but at 36 months the difference was significant only for the BPD with chronic oxygen dependency vs no-BPD group (P<0.001).Conclusions:At 36 months, children diagnosed with BPD with chronic oxygen dependency at NICU discharge were more likely to need respiratory medications and supplemental oxygen in the previous 12 months, as compared with no-BPD or BPD groups. They were also more likely to require frequent physician visits and have PNCLD at 3 years, as compared with the no-BPD group.

A New IVH Scoring System Based on Laterality Enhances Prediction of Neurodevelopmental Outcomes at 3 Years Age in Premature Infants

Objective To compare the new intraventricular hemorrhage (IVH) Abdi score to the Papile grading system of IVH for prediction of composite outcome of death or neurodevelopmental impairment (NDI). Methods In a cohort study, all preterm infants with IVH who were born ≤1,250 g and/or ≤ 28 weeks of gestation at birth were prospectively followed up in our neonatal follow‐up clinic. All cranial ultrasounds of the included infants were reviewed by neuroradiologists who were blinded to the clinical data and neurodevelopmental outcomes. Cranial ultrasounds were graded according to the Papile scoring system and by calculation of the Abdi score. Results A total of 183 preterm infants met inclusion and exclusion criteria. Of these, 80 (44%) had the composite primary outcome of death or NDI (51 died, 29 survived with NDI). The area under receiver operating characteristic curve for predicting death or NDI was 0.87 (95% confidence interval [CI]: 0.81‐0.93) for Abdi score and 0.85 (95% CI: 0.79‐0.91) for Papile grading (p = 0.04). Abdi scores had higher specificity than Papile grade II at Abdi score 5 (63.9 vs. 39.2%; p < 0.001) and Abdi score 6 (73.2 vs. 39.2%; p < 0.001). Conclusion Abdi scores seem to be more specific than Papile grading system in predicting death or NDI by 3 years corrected age.