Adverse events associated with pessary use over one year among women attending a pessary care clinic.

INTRODUCTION AND HYPOTHESIS: The primary objective was to determine the adverse event rate associated with pessary use. Secondary objectives were to determine discontinuation, patient satisfaction, and factors associated with adverse events. METHODS: A retrospective observational study included patients attending a nurse-led pessary clinic with ≥ 1 year follow-up. Patients were fitted with a pessary by a urogynecologist and pessary care by a nurse was performed every 3-4 months. Demographic characteristics, pessary fitting, adverse events, their management and discontinuation were recorded. Pearson Chi-square and Fisher exact tests assessed the association between predetermined risk factors and pessary complications or discontinuation. Relative risk and 95% confidence intervals were computed. RESULTS: 215 women were followed for a mean (standard deviation) of 4.4 (1.9) years. Mean age was 73.8 (8.7) years. Adverse event rate was 83.7%; most commonly vaginal discharge, vaginal bleeding and erosions. Women with cardiovascular risk factors were less likely to develop pessary-related adverse events (79.7% vs. 91.9%, p = 0.03). Gellhorn and donut pessaries were more commonly associated with pessary erosions than ring with support pessaries or incontinence rings (RR 2.37 [1.67; 3.38]). Thirty-five (16.3%) women discontinued pessary use at a mean of 3.3 (1.7) years after initial fitting. Having a pessary erosion was not associated with discontinuation (p = 0.698), but recurrent erosions were (p = 0.012). CONCLUSION: Adverse events were common among women continuing to use pessaries past 1 year, but adherence and satisfaction rates remained high after 4.4 years. Pessary type and absence of cardiovascular factors were associated with pessary-related adverse events.

Outcomes of trocar-guided Gynemesh PS™ versus single-incision trocarless Polyform™ transvaginal mesh procedures.

INTRODUCTION AND HYPOTHESIS: The aim of the study was to compare rates of success, mesh exposure, and surgical re-intervention after trocar-guided Gynemesh PS™ and trocarless Polyform™ transvaginal mesh procedures. METHODS: We conducted a retrospective cohort study of all transvaginal mesh procedures performed at our centers between January 2008 and May 2012. Multiple logistic regression models were used to explore the binary outcomes of objective and subjective success rates, as well as mesh exposure and re-intervention rates, between the two procedures after adjustment for patient's age, parity, body mass index, smoking status, previous hysterectomy, previous prolapse surgery, and follow-up time. RESULTS: We included 103 transvaginal mesh procedures (47 trocar-guided Gynemesh PS™ and 56 trocarless Polyform™). In both groups, Pelvic Organ Prolapse Quantification (POP-Q) scores were significantly improved after the procedure. Median follow-up was 340 days and interquartile range (IQR) 152-644. Objective success rates were 55.3 % (26/47) in the trocar group and 60.7 % (34/56) in the trocarless group (p = 0.9), whereas subjective success was 83.0 % (39/47) and 94.6 % (53/56), respectively (p = 0.1). The adjusted odds of developing mesh exposure were significantly less after trocarless transvaginal mesh procedures compared to trocar-guided ones [odds ratio (OR) 0.16, 95 % confidence interval (CI) 0.03-0.97]. Surgical re-interventions, aimed mostly at treating recurrent prolapse, mesh exposure, and latent stress urinary incontinence, were also significantly less frequent after trocarless procedures [5 patients (8.9 %) requiring re-intervention versus 15 (31.9 %), respectively, adjusted OR 0.15, 95 % CI 0.04-0.60]. CONCLUSIONS: Trocar-guided Gynemesh PS™ and trocarless Polyform™ transvaginal mesh systems result in similar objective and subjective success rates. The newer Polyform™ mesh results in significantly fewer mesh exposures and surgical re-interventions.

Screening for bacterial vaginosis at the time of intrauterine contraceptive device insertion: is there a role?

OBJECTIVE: To estimate the prevalence of bacterial vaginosis (BV) among women attending outpatient gynaecology clinics for insertion of an intrauterine contraceptive device (IUD); and to describe any differences between BV-positive and BV-negative women at one month after insertion with respect to four primary clinical outcomes: expulsion of IUD, pain, fever > 38 ºC, and heavy bleeding. METHODS: We carried out an observational prevalence study between March 2008 and March 2009. Seventy women were each followed for one month. Vaginal cultures for BV were obtained before and at one month after IUD insertion, and women were assessed for complications at one month after insertion. Thirty-eight women had a copper IUD (Cu-IUD) inserted and 32 had a levonorgestrel-releasing IUD (LNG-IUD) inserted. Bacterial vaginosis was diagnosed using Nugent's scoring and Gram stain evaluation of the cultures. Frequency distributions, Student t test, and Fisher exact test of independence were used to analyze the data. RESULTS: The prevalence of BV was 7.1%. Five women were found to be BV positive at the time of IUD insertion, and none experienced any clinical complications. One BV-negative patient developed a tubo-ovarian abscess three months after LNG-IUD insertion, and another BV-negative patient reported persistent, thick vaginal discharge after Cu-IUD insertion. Of 43 BV-negative patients who had repeat cultures performed at their one-month follow-up visit, four (9.3%) shifted from having normal flora to being BV positive. We found no significant relationship between a patient's BV status and any clinical outcome. CONCLUSION: The incidence of BV in this study was lower than that described in other populations. No clinical complications occurred among the BV-positive women. Screening for BV prior to IUD insertion is neither currently recommended, nor supported by our study findings.