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BACKGROUND We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a(More)
BACKGROUND For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort(More)
BACKGROUND Severity of illness, sociodemographic factors, and breastfeeding have been identified as predictors of consultation rates in infants, and prescriptions for antibiotics have been found to increase future consultation rates in older children. The Baby Check trial (1996-1998) provided detailed information about consultations for 935 babies during(More)
This systematic review examined the use of incontinence-specific quality of life (QOL) measures in clinical trials of female incontinence treatments, and systematically evaluated their quality using a standard checklist. Of 61 trials included in the review, 58 (95.1%) used an incontinence-specific QOL measure. The most commonly used were IIQ (19 papers),(More)
In 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate(More)
BACKGROUND Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the(More)
Objective To examine the approaches to protection of intellectual property in multi-centre trials currently being conducted in Canada. Methods Two ongoing international multicentre perinatal trials, both funded by the Canadian Institutes of Health Research, were selected for study on the basis of their contrasting approaches to protecting intellectual(More)
INTRODUCTION Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study(More)
Objective: To outline the evidence for conservative management options for treating urinary incontinence. Options: Conservative management options for treating urinary incontinence include behavioural changes, lifestyle modification, pelvic floor retraining, and use of mechanical devices. Outcomes: To provide understanding of current available evidence(More)
BACKGROUND Several studies and a recent meta-analysis have suggested that previous Cesarean section may increase the risk of stillbirth in a subsequent pregnancy. Given the high rates of Cesarean section in contemporary obstetric practice, this is of considerable public health importance. We sought to evaluate the potential that this association is the(More)