Transition to surgery after pessary among female Medicare beneficiaries with pelvic organ prolapse.

BACKGROUND: The American College of Obstetricians and Gynecologists recommends offering a vaginal pessary to women seeking treatment of pelvic organ prolapse. However, single-institution series have suggested that a sizable proportion of women fitted with a pessary will transition to surgery within the first year. OBJECTIVE: This study aimed to estimate the proportion of female US Medicare beneficiaries with pelvic organ prolapse who undergo surgery after pessary fitting, to describe the median time to surgery from pessary fitting, and to identify factors associated with the transition from pessary to surgery. STUDY DESIGN: The Medicare 5% Limited Data Set was queried from 2011 to 2016 for women aged ≥65 years with a diagnosis of prolapse who underwent pessary fitting. Cases with at least 3 years of follow-up in the Medicare Data Set were followed longitudinally for the primary outcome of surgery for prolapse. The cumulative incidence of prolapse surgery following index pessary fitting was calculated. Characteristics of women who underwent surgery and those who did not were compared using time-varying Cox regression analysis. RESULTS: Among 2032 women fitted with a pessary, 608 underwent surgery within 7 years. The median time to surgery was 496 days (interquartile range, 187-1089 days). The cumulative incidence of prolapse surgery was 12.2% at 1 year and 30.9% at 7 years. After adjusting for covariates, factors significantly associated with the transition to surgery included previous prolapse surgery (adjusted hazard ratio, 1.50; 1.09-2.07) and a diagnosis of urinary incontinence at the time of pessary fitting (adjusted hazard ratio, 1.20; 0.62-0.99). Factors associated with a lower hazard of surgery included age (adjusted hazard ratio, 0.96 per year; 95% confidence interval, 0.95-0.97), dual Medicare/Medicaid eligibility (adjusted hazard ratio, 0.75; 95% confidence interval, 0.56-1.00), and pessary fitting by a nongynecologist (adjusted hazard ratio, 0.78; 95% confidence interval, 0.62-0.99). CONCLUSION: In this population of Medicare beneficiaries, within 7 years of pessary fitting, almost one-third of women aged >65 years underwent surgery for prolapse. These results add to our current understanding of the demographics of pessary use in an older population and may aid in counseling older patients presenting for treatment of symptomatic pelvic organ prolapse.

Definitions of apical vaginal support loss: a systematic review.

OBJECTIVE: We sought to identify and summarize definitions of apical support loss utilized for inclusion, success, and failure in surgical trials for treatment of apical vaginal prolapse. BACKGROUND: Pelvic organ prolapse is a common condition affecting more than 3 million women in the US, and the prevalence is increasing. Prolapse may occur in the anterior compartment, posterior compartment or at the apex. Apical support is considered paramount to overall female pelvic organ support, yet apical support loss is often underrecognized and there are no guidelines for when an apical support procedure should be performed or incorporated into a procedure designed to address prolapse. STUDY DESIGN: A systematic literature search was performed in 8 search engines: PubMed 1946-, Embase 1947-, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Review Effects, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Proquest Dissertations and Theses, and FirstSearch Proceedings, using key words for apical pelvic organ prolapse and apical suspension procedures through April 2016. Searches were limited to human beings using human filters and articles published in English. Study authors (M.R.L.M., J.L.L.) independently reviewed publications for inclusion based on predefined variables. Articles were eligible for inclusion if they satisfied any of the following criteria: (1) apical support loss was an inclusion criterion in the original study, (2) apical support loss was a surgical indication, or (3) an apical support procedure was performed as part of the primary surgery. RESULTS: A total of 4469 publications were identified. After review, 35 articles were included in the analysis. Prolapse-related inclusion criteria were: (1) apical prolapse (n = 20, 57.1%); (2) overall prolapse (n = 8, 22.8%); or (3) both (n = 6, 17.1%). Definitions of apical prolapse (relative to the hymen) included: (1) apical prolapse >-1 cm (n = 13, 50.0%); (2) apical prolapse >+1 cm (n = 7, 26.9%); (3) apical prolapse >50% of total vaginal length (-[total vaginal length/2]) (n = 4, 15.4%); and (4) cervix/apex >0 cm (n = 2, 7.7%). Sixteen of the 35 studies (45.7%) required the presence of symptoms for inclusion. A measurement of the apical compartment (relative to the hymen) was used as a measure of surgical success or failure in 17 (48.6%) studies. Definitions for surgical success included: (1) prolapse stage >2 in each compartment (n = 5, 29.4%); (2) prolapse >-[total vaginal length/2] (n = 2, 11.8%); (3) apical support >-[total vaginal length/3] (n = 1, 5.9%); (4) absence of prolapse beyond the hymen (n = 1, 5.9%); and (5) point C at ≥-5 cm (n = 2, 11.8%). Surgical failure was defined as: (1) apical prolapse ≥0 cm (n = 2, 11.8%); (2) apical prolapse ≥-1 cm (n = 2, 11.8%); (3) apical prolapse >-[total vaginal length/2] (n = 3, 17.6%); and (4) recurrent apical prolapse surgery (n = 1, 5.9%). Ten (28.6%) of the 35 studies also included symptomatic outcomes in the definition of success or failure. CONCLUSION: Among randomized, controlled surgical trials designed to address apical vaginal support loss, definitions of clinically significant apical prolapse for study inclusion and surgical success or failure are either highly variable or absent. These findings provide limited evidence of consensus and little insight into current expert opinion.

Predicting obstetric anal sphincter injuries in a modern obstetric population.

BACKGROUND: Perineal lacerations are common at the time of vaginal delivery and may predispose patients to long-term pelvic floor disorders, such as urinary incontinence and pelvic organ prolapse. Obstetric anal sphincter injuries, which are the most severe form of perineal lacerations, result in disruption of the anal sphincter and, in some cases, the rectal mucosa during vaginal delivery. Long-term morbidity, including pain, pelvic floor disorders, fecal incontinence, and predisposition to recurrent injury at subsequent delivery may result. Despite several studies that have reported risk factors for obstetric anal sphincter injuries, no accurate risk prediction models have been developed. OBJECTIVE: The purpose of this study was to identify risk factors and develop prediction models for perineal lacerations and obstetric anal sphincter injuries. STUDY DESIGN: This was a nested case control study within a retrospective cohort of consecutive term vaginal deliveries at 1 tertiary care facility from 2004-2008. Cases were patients with any perineal laceration that had been sustained during vaginal delivery; control subjects had no lacerations of any severity. Secondary analyses investigated obstetric anal sphincter injury (3rd- to 4(th)-degree laceration) vs no obstetric anal sphincter injury (0 to 2(nd)-degree laceration). Baseline characteristics were compared between groups with the use of the chi-square and Student t test. Adjusted odds ratios and 95% confidence intervals were calculated with the use of multivariable logistic regression. Prediction models were created and model performance was estimated with receiver-operator characteristic curve analysis. Receiver-operator characteristic curves were validated internally with the use of the bootstrap method to correct for bias within the model. RESULTS: Of the 5569 term vaginal deliveries that were recorded during the study period, complete laceration data were available in 5524 deliveries. There were 3382 perineal lacerations and 249 (4.5%) obstetric anal sphincter injuries. After adjusted analysis, significant predictors for laceration included nulliparity, non-black race, longer second stage, nonsmoking status, higher infant birthweight, and operative delivery. Private health insurance, labor induction, pushing duration, and regional anesthesia were not statistically significant in adjusted analyses. Significant risk factors for obstetric anal sphincter injury were similar to predictors for any laceration; nulliparity and operative vaginal delivery had the highest predictive value. Area under the curve for the predictive ability of the models was 0.70 for overall perineal laceration, and 0.83 for obstetric anal sphincter injury. When limited to primiparous patients, 1996 term vaginal deliveries were recorded. One hundred ninety-two women sustained an obstetric anal sphincter injury; 1796 women did not. After adjusted analysis, significant predictors for laceration included non-black race, age, obesity, and nonsmoking status. In secondary analyses, significant predictors for obstetric anal sphincter injury included non-black race, nonsmoking status, longer duration of pushing, operative vaginal delivery, and infant birthweight. Area under the curve for the predictive ability of the models was 0.60 for any laceration and 0.77 for obstetric anal sphincter injury. CONCLUSIONS: Significant risk factors for sustaining any laceration and obstetric anal sphincter injury during vaginal deliveries were identified. These results will help identify clinically at-risk patients and assist providers in counseling patients about modifications to decrease these risks.