Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence.

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females. METHODS: A multicenter, interventional, single-arm study involving 5 different sites was conducted including women diagnosed with symptomatic SUI using a self-inserted pessary device. A 1-week baseline period was followed by a 2-week period of wearing the device. The main outcome of our study was to determine if the device was able to reduce at least 50% the number of leakage events and pad weight. RESULTS: Across all study sites, 73 subjects were enrolled and 51 completed the study. Efficacy analyses were conducted on the modified intent-to-treat population (n = 48), whereas the safety analysis was conducted on all consented participants. The average pad weight gain was 0.9 g/h at baseline and 0.5 g/h during the treatment phase. The number of leakage episodes per day decreased from 2 at baseline to 0.9 during the treatment phase (P < 0.0001). Seventy-one percent of the study population experienced a more than 50% reduction in leakage volume, leakage episodes, or both. The quality of life scores improved from baseline to posttreatment phase by 4.35 points on average (P < 0.0001). A total of 40 adverse events were recorded, and only 4 subjects withdrew due to adverse events. CONCLUSIONS: The self-deployable pessary device evaluated in this study is an alternative option for women seeking an over-the-counter method to manage symptoms of SUI. Further studies are required to determine the long-term effects and compliance using the device.

The Effect of Toileting Position in Uroflow Curves in Young Healthy Nulliparous Women.

The objective of our study was to determine the effect of voiding positions on uroflow parameters in young, healthy nulliparous women with no pelvic floor disorders. Material and Methods. From December 2017 to February 2018, we performed a single-institution cross-sectional study with 30 healthy volunteers comparing uroflow curves in sitting and hovering positions. 49 participants were initially prescreened with a validated tool questionnaire for pelvic floor disorders and 30 participants who had absent symptoms were included for the final analysis. From the selected participants, demographics were collected and comparisons between the sitting and hovering position groups regarding the maximum flow rate (Qmax), average flow rate (Qave), voided volume (VV), and time to peak flow (TQmax) were conducted using either the paired t-test or the Wilcoxon rank sum test. In addition, linear regression analysis was performed to determine whether height, BMI, and age have significant impact on the log-transformed average of the pre- and postvalues of either Qmax, Qave, VV, or TQmax, as the average of these values are not normally distributed. Results. There were no statistical differences between the hovering and sitting position groups on the maximum flow rate (p=0.93), average flow rate (p=0.82), voided volume (p=0.53), and time to peak flow (p=0.82). BMI had borderline significant impact on Qave with p value = 0.0531. Conclusion. Different voiding toileting habits do not affect the most commonly used uroflow parameters in young healthy nulliparous patients. Results need to be corroborated by a larger scale study considering the small sample size of our study.